Chronic Fatigue SyndromeNCT05130099
A Complex Intervention for Chronically Fatigued Lymphoma Survivors
A study testing Interdisciplinary complex intervention in people with Chronic Fatigue Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Interdisciplinary complex intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 20 Nov 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors of Hodgkin and aggressive non-Hodgkin lymphoma
- Not indolent non-Hodgkin lymphoma
- Not CNS lymphoma at diagnosis
- Not second cancer
- Not ongoing cancer treatment
- Chronic fatigue measured by Chalder Fatigue Questionnaire
Show all 12Show fewer
- Diagnosed 2010-2020
- Received treatment with curative intent
- 18 - 70 years old at inclusion
- > 2 years since last treatment
- Able to understand the Norwegian language
- Participation approval from oncologist in the project group
Who cannot join
- Persisting fatigue > 1 year before the cancer diagnosis
- Somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches)
- Psychiatric or mental disorders (i.e. dementia, severe depression, schizophrenia)
- Use of stimulants for ADHD
- Substance abuse disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.
Read the detailed description
Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking.
Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom.
The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion.
The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway.
All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Interdisciplinary complex intervention
- Keywords
- lymphoma, cancer survivorship, physical activity, nutrition, patient education, cognitive behavioral program
- Medical subject headings
- Fatigue Syndrome, Chronic, Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary complex interventionOther
The interdisciplinary complex intervention lasts 12 weeks and includes the 4 following components;
Patient-education: a 2-hours group-based digital session, including information about fatigue, training theory, psychological strategies and nutrition, all in relation to chronic fatigue (CF).
Physical exercise program: two weekly sessions with aerobic exercise and resistance training. The participants are instructed to do the same program in the unsupervised sessions as in the supervised sessions. After the first 12 weeks exercise period, the participant and the physiotherapist makes an individually tailored plan for exercise and follow-up the next 12 weeks.
Cognitive behavioral program: 6 group-based online sessions lead by two psychologists, based on elements from cognitive behavioral therapy to reduce and/or manage CF. Each session lasts for 135 minutes.
Nutritional counselling: 3 individual sessions by a clinical dietitian. Each session lasts for 30-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary complex intervention | Experimental | Not described Receives: Other: Interdisciplinary complex intervention |
| Usual care | No intervention | Six months after the intervention period (T3), the participants randomized to usual care will be offered a modified version of the intervention in line with their personally expressed needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.
Measured: From baseline (T0) to 12 weeks (T1)
Secondary outcomes (83)
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
Measured: From baseline (T0) to 36 weeks (T3)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
Measured: From post-intervention (T1) to 12-month follow-up (T4)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3, providing a total score from 0 to 33. Higher score implies more fatigue.
Measured: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning.
Measured: From baseline (T0) to 36 weeks (T3)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning.
Measured: From post-intervention (T1) to 12-month follow-up (T4)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes five functioning scales (physical, role, cognitive, emotional and social).All of the scales range in score from 0 to 100.
A high score for a functional scale represents a high / healthy level of functioning.
Measured: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 36 weeks (T3)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From post-intervention (T1) to 12-month follow-up (T4)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Participants are asked to report their current work status
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Participants are asked to report their current work status
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Participants are asked to report their current work status
Measured: From baseline (T0) to 36 weeks (T3)
Change in work status in both groups assessed by questions from the HUNT4-study
Participants are asked to report their current work status
Measured: From post-intervention (T1) to 12 months follow-up (T4)
Change in work status in both groups assessed by questions from the HUNT4-study
Participants are asked to report their current work status
Measured: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
Measured: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index scale
Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
Measured: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index scale
Current work ability is rated compared with the lifetime best on a scale from 0 to 10. Higher score implies higher work ability.
Measured: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Assessed by rating work ability in relation to the physical demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Assessed by rating work ability in relation to the psychological demands of the job, by the following response alternatives: very good, rather good, moderate, rather poor or very poor
Measured: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Peak oxygen uptake (VO2peak) is measured
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Peak oxygen uptake (VO2peak) is measured
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Peak oxygen uptake (VO2peak) is measured
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
In cases where participants do not have the opportunity to travel for physical fitness tests, cardiorespiratory fitness will be assessed by an indirect treadmill test (modified Balke protocol) at their local physiotherapist. Time to exhaustion will be used as an indicator of cardiorespiratory fitness.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in lower body muscle strength between groups assessed by leg press
The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in lower body muscle strength between groups assessed by leg press
The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in lower body muscle strength between groups assessed by leg press
The one-repetition maximum (1RM) test (the maximal workload that can be lifted once)) in leg press.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in lower body muscle strength between groups assessed by push-ups
The maximum number of push-ups that can be performed in one set
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in upper body muscle strength between groups assessed by push-ups
The maximum number of push-ups that can be performed in one set
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in upper body muscle strength between groups assessed by push-ups
The maximum number of push-ups that can be performed in one set
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in level of depressive symptoms between groups assessed by the Patient Health Questionnaire-9
Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
Measured: From baseline (T0) to 36 weeks (T3)
Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
Measured: From post-intervention (T1) to 12-month follow-up (T4)
Change in level of depressive symptoms among all participants assessed by the Patient Health Questionnaire-9
Each of the 9 items is scored from 0-3, providing a total score from 0 to 27. A higher score implies higher level of depressive symptoms.
Measured: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Each item is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in level of anxiety symptoms between groups assessed by the General Anxiety Disorder 7-items (GAD7).
Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
Measured: From baseline (T0) to 36 weeks (T3)
Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
Measured: From baseline (T0) to 12 months follow-up weeks (T4)
Change in level of anxiety symptoms in all participants assessed by the General Anxiety Disorder 7-items (GAD7).
Each of the 7 items is scored from 0-3, providing a total score from 0-21. A higher score implies higher level of anxiety symptoms.
Measured: From baseline (T0) to 24 months follow-up weeks (T5)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in sense of exercise competence between groups assessed by the Perceived Competence Scale.
The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
Measured: From baseline (T0) to 36 weeks (T3)
Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
Measured: From post-intervention (T1) to 12 months follow-up (T4)
Change in sense of exercise competence in both groups assessed by the Perceived Competence Scale.
The scale consists of 4 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 0 to 7 is calculated based on the mean score of the items, with increasing score implying higher exercise competence.
Measured: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in satisfaction with life between groups assessed by the Satisfaction With Life Scale.
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher satisfaction with life.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in sense of vitality between groups assessed by the Subjective Vitality Scale
The scale consists of 5 items, each scored from 1 (totally disagree) to 7 (totally agree). A sum score from 5 to 35 is calculated, with increasing score implying higher sense of vitality.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in adherence to the Norwegian food-based dietary guidelines between groups assessed by DIGIKOST-FFQ
DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in adherence to the Norwegian food-based dietary guidelines assessed by DIGIKOST-FFQ
DIGIKOST-FFQ is a food frequency questionnaire aiming to benchmark against the Norwegian food-based dietary guidelines.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in general health between groups measured by European Quality of Life Five-Dimension Scale Questionnaire (EQ-5D)
EQ-5D consists of five dimensions (mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by Research and Development 36-term Short Form Health Survey (RAND SF-36)
RAND-36 comprises 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales.All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Measured: From baseline (T0) to 36 weeks (T3)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 12 weeks (T1)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 24 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 36 weeks (T2)
Difference in change in quality of life among the relatives between groups measured by the global health status / QoL scale from the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
The questionnaire includes a global health status / quality of life (QoL) scale, which range in score from 0 to 100. A high score for the global health status / QoL represents a high QoL.
Measured: From baseline (T0) to 36 weeks (T3)
Cost-effectiveness of the intervention, calculated based on measurements of health-related QoL and resource use (costs related to the intervention).
Combining information about health-related QoL will give quality-adjusted life-years, while valuation of resource use using standard principles of health economic evaluation will provide estimates of costs
Measured: From baseline (0) to 36 weeks (T3)
Perceived benefits of the intervention components assessed by questions used in and modified from the PasOpp study from the Directorate of Health in Norway
Questions assessing benefits of the intervention
Measured: At 12- and 24-month follow-up
Use of information, experiences, strategies and advices learned in the intervention program assessed by self-made questions
Questions assessing daily use of information, strategies and advices learned in the intervention program
Measured: At 12- and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start20 Nov 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian School of Sport Sciences, UiT The Arctic University of Norway, Norwegian University of Science and Technology, Diakonhjemmet Hospital, University of Alberta, St. Olavs Hospital
- Responsible party
- Principal investigator, Lene Thorsen, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130099
- Sponsor's protocol ID
- #153665
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohn SH, Reinertsen KV, Kiserud CE, Loge JH, Fossa A, Skaali T, Blomhoff R, Oldervoll LM, Courneya KS, Raastad T, Nilsen TS, Wisloff T, Lie HC, Berge T, Edvardsen E, Fagerli UM, Fjerstad E, Gjerset GM, Haavik I, Henriksen HB, Rutkovskiy A, Sandberg G, Seland M, Slott M, Tjessem KH, Viktil L, Thorsen L. Effects of a Multidisciplinary Intervention on Fatigue in Lymphoma Survivors With Chronic Fatigue: Protocol for a Randomized Controlled Trial (REFUEL). JMIR Res Protoc. 2025 Aug 29;14:e69336. doi: 10.2196/69336.
PubMed 40882189
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Complex Intervention for a Complex Symptom - a Randomized Controlled Trial in Chronically Fatigued Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT05130099
- Acronym / sponsor ID
- #153665
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- lymphoma, cancer survivorship, physical activity, nutrition, patient education, cognitive behavioral program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian School of Sport Sciences, UiT The Arctic University of Norway, Norwegian University of Science and Technology, Diakonhjemmet Hospital, University of Alberta, St. Olavs Hospital
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a randomized controlled trial (RCT) with an overall objective to examine the effect of an interdisciplinary complex intervention on the level of fatigue in lymphoma survivors with chronic fatigue. Secondary aims are to examine the effects of the intervention on daily functioning, work status/ability, physical fitness and QoL among the survivors, on QoL of their relatives and on the societal costs.The intervention will last for 12+12 weeks and include four components; patient education, supervised physical exercise, cognitive behavioral program and nutritional counselling. Outcomes will be assessed at baseline,post-intervention (12 weeks after baseline) and at 3-month, 6-month, 12-month and 24-month follow-up after completed intervention.
Detailed description
Chronic fatigue (CF) is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking.
Today, there is no curative treatment of CF. However, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom.
The project is a two-armed RCT in which chronically fatigued lymphoma survivors are randomized to an interdisciplinary complex intervention or to usual care. Eligible participants will receive written information about the study by mail. Survivors who perceive themselves as having physical and mental fatigue, and who are willing to participate, will be asked to fill out and return the Chalder Fatigue Questionnaire (FQ) to the study coordinator. Those who have chronic fatigue as measured by the FQ will be invited to a medical screening by an oncologist in the project group, for evaluation of inclusion.
The interdisciplinary complex intervention will last for 12 + 12 weeks and include four components; patient education, physical exercise (and follow-up), cognitive behavioral program and nutritional counselling, organized in a systematic way, i.e. a standardized patient care pathway.
All outcomes will be assessed in all participants at four points; pre-intervention (baseline) (T0), post-intervention (12 weeks after baseline) (T1) and at 3-month (T2) and 6-month (T3) after T1. Moreover, selected patient reported outcomes will be assessed in all participants at 12-month (T4) and 24-month (T5) after T1.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary complex intervention | Experimental | Other: Interdisciplinary complex intervention |
| Usual care | No intervention | –Six months after the intervention period (T3), the participants randomized to usual care will be offered a modified version of the intervention in line with their personally expressed needs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Survivors of Hodgkin and aggressive non-Hodgkin lymphoma
- Not indolent non-Hodgkin lymphoma
- Not CNS lymphoma at diagnosis
- Not second cancer
- Not ongoing cancer treatment
Key exclusion criteria (5 listed)
- Persisting fatigue > 1 year before the cancer diagnosis
- Somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches)
- Psychiatric or mental disorders (i.e. dementia, severe depression, schizophrenia)
- Use of stimulants for ADHD
- Substance abuse disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary complex interventionThe interdisciplinary complex intervention lasts 12 weeks and includes the 4 following components; Patient-education: a 2-hours group-based digital session, including information about fatigue, training theory, psychological strategies and nutrition, all in relation to chronic fatigue (CF). Physical exercise program: two weekly sessions with aerobic exercise and resistance training. The participants are instructed to do the same program in the unsupervised sessions as in the supervised sessions. After the first 12 weeks exercise period, the participant and the physiotherapist makes an individually tailored plan for exercise and follow-up the next 12 weeks. Cognitive behavioral program: 6 group-based online sessions lead by two psychologists, based on elements from cognitive behavioral therapy to reduce and/or manage CF. Each session lasts for 135 minutes. Nutritional counselling: 3 individual sessions by a clinical dietitian. Each session lasts for 30-60 minutes. | Other | Interdisciplinary complex intervention |
Primary outcome
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire
Time frame: From baseline (T0) to 12 weeks (T1)
The Fatigue Questionnaire consists of 11 questions, distributed on a physical fatigue scale (7 items) and mental fatigue scale (4 items) Each item is scored from 0 to 3. This provides a physical fatigue score from 0 to 21, mental fatigue score from 0 to 12, and total score from 0 to 33. Higher score implies more fatigue.
83 secondary outcomes
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in fatigue levels between groups assessed by Chalder Fatigue Questionnaire
Time frame: From baseline (T0) to 36 weeks (T3)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
Time frame: From post-intervention (T1) to 12-month follow-up (T4)
Change in fatigue levels among all participants assessed by Chalder Fatigue Questionnaire
Time frame: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in daily functioning between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 36 weeks (T3)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From post-intervention (T1) to 12-month follow-up (T4)
Change in daily functioning among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in global quality of life between groups assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From baseline (T0) to 36 weeks (T3)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From post-intervention (T1) to 12-month follow-up (T4)
Change in global quality of life among all participants assessed by European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: From post-intervention (T1) to 24-month follow-up (T5)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in work status between groups assessed by questions from the HUNT4-study
Time frame: From baseline (T0) to 36 weeks (T3)
Change in work status in both groups assessed by questions from the HUNT4-study
Time frame: From post-intervention (T1) to 12 months follow-up (T4)
Change in work status in both groups assessed by questions from the HUNT4-study
Time frame: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index scale
Time frame: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index scale
Time frame: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index scale
Time frame: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: physical demands of the job
Time frame: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Time frame: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: physical demands of the job
Time frame: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in work ability between groups assessed by the Work Ability Index: psychological demands of the job
Time frame: From baseline (T0) to 36 weeks (T3)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Time frame: From post-intervention (T1) to 12 months follow-up (T4)
Change in work ability in both groups assessed by the Work Ability Index: psychological demands of the job
Time frame: From post-intervention (T1) to 24 months follow-up (T5)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by cardio-pulmonary exercise testing (CPET)
Time frame: From baseline (T0) to 36 weeks (T3)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Time frame: From baseline (T0) to 12 weeks (T1)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Time frame: From baseline (T0) to 24 weeks (T2)
Difference in change in cardiorespiratory fitness between groups assessed by a treadmill test
Time frame: From baseline (T0) to 36 weeks (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40882189Bohn SH, Reinertsen KV, Kiserud CE, Loge JH, Fossa A, Skaali T, Blomhoff R, Oldervoll LM, Courneya KS, Raastad T, Nilsen TS, Wisloff T, Lie HC, Berge T, Edvardsen E, Fagerli UM, Fjerstad E, Gjerset GM, Haavik I, Henriksen HB, Rutkovskiy A, Sandberg G, Seland M, Slott M, Tjessem KH, Viktil L, Thorsen L. Effects of a Multidisciplinary Intervention on Fatigue in Lymphoma Survivors With Chronic Fatigue: Protocol for a Randomized Controlled Trial (REFUEL). JMIR Res Protoc. 2025 Aug 29;14:e69336. doi: 10.2196/69336.
Related trials for Chronic Fatigue Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
RecruitingPhase 2
LIFT: Life Improvement Trial
ME/CFS, Long COVID
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary complex intervention in people with Chronic Fatigue Syndrome, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in fatigue levels (physical-, mental- and total fatigue) between intervention and control group, assessed by the Chalder Fatigue Questionnaire (time frame: From baseline (T0) to 12 weeks (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.