FatigueNCT04931407
A Feasibility Study in Chronically Fatigued Cancer Survivors
A study testing A 12-week interdisciplinary complex intervention in people with Fatigue and Lymphoma, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect… Read more about this study
- Who is it for?
- Ages 19 to 67 years
- What is being tested?
- A 12-week interdisciplinary complex intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 6 Apr 2021to 31 Jan 2022
- 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 19 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors of Hodgkin and aggressive non-Hodgkin lymphoma, diagnosed 2014 or 2019 (n=7)
- 18-65 years at diagnosis, and 19-67 years at participation.
- CF measured by Chalder FQ.
- Curatively treated, more than 2 years since last treatment.
- Participation approval from oncologist.
Who cannot join
- Indolent non-Hodgkin lymphoma.
- Fatigue more than one year before the cancer diagnosis.
- Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches).
- Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder.
- In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF).
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.
Read more
CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, 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 Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF.
During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021.
- Being tested
- A 12-week interdisciplinary complex intervention
- Keywords
- exercise, chronic fatigue, lymphoma, cancer survivors, nutrition, cognitive therapy, patient education
- Medical subject headings
- Fatigue, Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 12-week interdisciplinary complex interventionOther
The intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling.
The patient education will include an online 2-hours group-based patient-education sessions in week 1.
The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists.
The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist.
The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary complex intervention | Experimental | The intervention includes patient education, physical exercise, a group-based cognitive behavioral program and individual nutritional counseling Receives: Other: A 12-week interdisciplinary complex intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Assessed by the number who consent to participate
Measured: The week before the intervention period (week 0)
Inclusion rate
Assessed by the number of consenting participants who are included (i.e. have chronic fatigue according to the Fatigue Questionnaire, and are cleared for participation by oncologist after the medical screening).
Measured: The week before the intervention period (week 0)
Completion rate
Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment
Measured: The week before the intervention period (week 0)
Strengths and weaknesses with the inclusion procedure: participants
Assessed by structured conversations with the participants
Measured: Week 4
Strengths and weaknesses with the inclusion procedure: study personnel
Assessed by structured conversations with the study personnel
Measured: Week 4
Feasibility of the patient education session: participants
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the participants after the patient education session.
Measured: Week 4
Feasibility of the patient education session: presenters
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the presenters after the patient education session.
Measured: Week 4
Feasibility of the exercise program part one (week 1-3): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Measured: Week 4
Feasibility of the exercise program part one (week 1-3): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Measured: Week 4
Feasibility of the exercise program part two (week 4-7): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Measured: Week 8
Feasibility of the exercise program part two (week 4-7): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Measured: Week 8
Compliance to the cognitive behavioral therapy groups sessions
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
Measured: Week 8
Feasibility of the cognitive behavioral therapy groups sessions: participants
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
Measured: Week 8
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
Measured: Week 8
Compliance to the nutrition counseling
Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
Measured: Week 11
Feasibility of the nutrition counseling: participants
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.
Measured: Week 11
Feasibility of the nutrition counseling: clinical dietitian
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the clinical dietitian after the last counseling session.
Measured: Week 11
Compliance to the exercise program: attendance
Registered by the physiotherapists in an exercise log
Measured: Week 13
Compliance to the exercise program: intensity during the aerobic exercise intervals
Registered by pulse sensors
Measured: Week 13
Compliance to the exercise program: implementation of the strength training exercises
Registered by the physiotherapists in an exercise log
Measured: Week 13
Feasibility of the exercise program part three (week 8-12): participants
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Measured: Week 13
Feasibility of the exercise program part three (week 8-12): physiotherapists
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Measured: Week 13
Feasibility of the questionnaires
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
Measured: Week 13
Feasibility of the physical tests: participants
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
Measured: Week 13
Feasibility of the physical tests: physiotherapists
Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
Measured: Week 13
Compliance to the physical tests
Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
Measured: Week 13
Completeness of the questionnaires
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
Measured: Week 13
Secondary outcomes (43)
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of fatigue
Measured by Chalder Fatigue Questionnaire. Total score range from 0 to 33, with increasing score implying more fatigue.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in daily functioning and global quality of life
Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range fro 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in subjective well-being
Measured by the Satisfaction with Life Scale. Total score range from 5 to 35, with increasing score implying higher subjective well-being.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in vitality
Measured by the Subjective Vitality Scale. The total score ranges from 6 to 36 with a higher score indicating a better condition
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in general health
Measured by European Quality of Life Five-dimension Scale Questionnaire (EQ-5D). Total score range from 5 (worst health) to 25 (best health).
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in work ability
Measured by Work Ability Index. Total score range from 7 to 49 points, with higher score indicating better work ability.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in anxiety symptoms
Measured by the General Anxiety Disorder 7-items. Total score range from 0 to 21 with increasing score implying higher level of anxiety.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in depressive symptoms
Measured by the Patient Health Questionnaire-9. Total score from 0 to 27, increasing score implying higher depressive symptoms.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of physical activity
Measured by the Godin Leisure Time Exercise Questionnaire
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in exercise mastery
Assessed by the Perceived Competence Scale. The scale consists of 4 items (statements). On each item, participants are asked to rate how true a statement is using a 7-point scale.Total score range from 4 to 28, with increasing score reflecting higher exercise mastery.
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in dietary intake of the participants
Measured by a digital food frequency questionnaire (DIGIKOST-FFQ)
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in meal pattern
Measured by the Meal Pattern Questionnaire
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Calculated by measuring weight and height
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Calculated by measuring weight and height
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in body mass index
Calculated by measuring weight and height
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in sleep problems
Measured by questions from the Trøndelag Health Survey
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in cardiorespiratory fitness
Assessed by a submaximal and indirect treadmill test (modified Balke protocol)
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in lower body muscle strength
Assessed by 30 second sit-to-stand test
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Measured: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in upper body muscle strength
Assessed by maximum repetitions of push-ups with various starting positions
Measured: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in quality of life among relatives
Assessed by the Research and Development 36-item Short Form Survey (RAND SF-36).The eight scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Change in global health status among relatives
The global health status / quality of life scale from the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores range from 0 to 100, a higher score represents a higher (better) level of functioning or a higher (worse) level of symptoms.
Measured: Change from baseline (week 0) and to post-intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start6 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 FatigueStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Diakonhjemmet Hospital, Norwegian School of Sport Sciences, Norwegian University of Science and Technology, University of Alberta, UiT The Arctic University of Norway
- Responsible party
- Principal investigator, Lene Thorsen, Oslo University Hospital
- Investigators
- Lene Thorsen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931407
- Sponsor's protocol ID
- 153665
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohn S, Oldervoll LM, Reinertsen KV, Seland M, Fossa A, Kiserud C, Skaali T, Nilsen TS, Blomhoff R, Henriksen HB, Lie HC, Berge T, Fjerstad E, Wisloff T, Slott M, Zajmovic I, Thorsen L. The feasibility of a multidimensional intervention in lymphoma survivors with chronic fatigue. Support Care Cancer. 2023 Dec 14;32(1):22. doi: 10.1007/s00520-023-08204-5.
PubMed 38095797
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study in Chronically Fatigued Cancer Survivors
- ClinicalTrials.gov ID
- NCT04931407
- Acronym / sponsor ID
- 153665
- Keywords
- exercise, chronic fatigue, lymphoma, cancer survivors, nutrition, cognitive therapy, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Diakonhjemmet Hospital, Norwegian School of Sport Sciences, Norwegian University of Science and Technology, University of Alberta, UiT The Arctic University of Norway
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Jun 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.
Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF).
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.
CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, 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 Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF.
During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary complex intervention | Experimental | Other: A 12-week interdisciplinary complex interventionThe intervention includes patient education, physical exercise, a group-based cognitive behavioral program and individual nutritional counseling |
Who may qualify
- Ages
- 19 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Survivors of Hodgkin and aggressive non-Hodgkin lymphoma, diagnosed 2014 or 2019 (n=7)
- 18-65 years at diagnosis, and 19-67 years at participation.
- CF measured by Chalder FQ.
- Curatively treated, more than 2 years since last treatment.
- Participation approval from oncologist.
Key exclusion criteria (5 listed)
- Indolent non-Hodgkin lymphoma.
- Fatigue more than one year before the cancer diagnosis.
- Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches).
- Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder.
- In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.
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 |
|---|---|---|
| A 12-week interdisciplinary complex interventionThe intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling. The patient education will include an online 2-hours group-based patient-education sessions in week 1. The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists. The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist. The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian. | Other | Interdisciplinary complex intervention |
Primary outcome
Recruitment rate
Time frame: The week before the intervention period (week 0)
Assessed by the number who consent to participate
Inclusion rate
Time frame: The week before the intervention period (week 0)
Assessed by the number of consenting participants who are included (i.e. have chronic fatigue according to the Fatigue Questionnaire, and are cleared for participation by oncologist after the medical screening).
Completion rate
Time frame: The week before the intervention period (week 0)
Assessed by the number of consenting participants consenting patients who complete any measurement at the final assessment
Strengths and weaknesses with the inclusion procedure: participants
Time frame: Week 4
Assessed by structured conversations with the participants
Strengths and weaknesses with the inclusion procedure: study personnel
Time frame: Week 4
Assessed by structured conversations with the study personnel
Feasibility of the patient education session: participants
Time frame: Week 4
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the participants after the patient education session.
Feasibility of the patient education session: presenters
Time frame: Week 4
Strengths, weaknesses, and usefulness of the contents in the education session will be assessed by structured conversations with the presenters after the patient education session.
Feasibility of the exercise program part one (week 1-3): participants
Time frame: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Feasibility of the exercise program part one (week 1-3): physiotherapists
Time frame: Week 4
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Feasibility of the exercise program part two (week 4-7): participants
Time frame: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Feasibility of the exercise program part two (week 4-7): physiotherapists
Time frame: Week 8
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Compliance to the cognitive behavioral therapy groups sessions
Time frame: Week 8
Participation to the cognitive behavioral therapy groups sessions will be registered by the study coordinators/psychologists..
Feasibility of the cognitive behavioral therapy groups sessions: participants
Time frame: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the participants after the last group session
Feasibility of the cognitive behavioral therapy groups sessions: psychologists
Time frame: Week 8
Strengths, weaknesses, and usefulness of the groups sessions will be assessed by structured conversations with the psychologists after the last group session
Compliance to the nutrition counseling
Time frame: Week 11
Participation rate of the individual nutrition counseling sessions will be registered by the clinical dietitian.
Feasibility of the nutrition counseling: participants
Time frame: Week 11
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the participants after the last counseling session.
Feasibility of the nutrition counseling: clinical dietitian
Time frame: Week 11
Strengths, weaknesses, and usefulness of the contents in the sessions will be assessed by structured conversations with the clinical dietitian after the last counseling session.
Compliance to the exercise program: attendance
Time frame: Week 13
Registered by the physiotherapists in an exercise log
Compliance to the exercise program: intensity during the aerobic exercise intervals
Time frame: Week 13
Registered by pulse sensors
Compliance to the exercise program: implementation of the strength training exercises
Time frame: Week 13
Registered by the physiotherapists in an exercise log
Feasibility of the exercise program part three (week 8-12): participants
Time frame: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the participants
Feasibility of the exercise program part three (week 8-12): physiotherapists
Time frame: Week 13
Strengths and weaknesses with the exercise program will be evaluated through structured conversations with the physiotherapists
Feasibility of the questionnaires
Time frame: Week 13
Strengths and weaknesses with the questionnaire will be evaluated through structured conversations with the participants.
Feasibility of the physical tests: participants
Time frame: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the participants.
Feasibility of the physical tests: physiotherapists
Time frame: Week 13
Strengths and weaknesses with the tests will be evaluated through structured conversations with the physiotherapists conducting the tests.
Compliance to the physical tests
Time frame: Week 13
Assessed by the completion rate of the physical tests (i.e. the number of participants who conduct the tests as planned).
Completeness of the questionnaires
Time frame: Week 13
Assessed by the completion rate of the questionnaire (i.e. proportion of missing).
43 secondary outcomes
Change in level of fatigue
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of fatigue
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of fatigue
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in daily functioning and global quality of life
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in daily functioning and global quality of life
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in daily functioning and global quality of life
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in subjective well-being
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in vitality
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in general health
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in work ability
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in work ability
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in anxiety symptoms
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in anxiety symptoms
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in anxiety symptoms
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in depressive symptoms
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in depressive symptoms
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in depressive symptoms
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in level of physical activity
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in level of physical activity
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in level of physical activity
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in exercise mastery
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in exercise mastery
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in exercise mastery
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in dietary intake of the participants
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in meal pattern
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in body mass index
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in body mass index
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in sleep problems
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in sleep problems
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in sleep problems
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in cardiorespiratory fitness
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in cardiorespiratory fitness
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in cardiorespiratory fitness
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in lower body muscle strength
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in lower body muscle strength
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Change in lower body muscle strength
Time frame: Change from baseline (week 0) to 7 months follow-up (week 42)
Change in upper body muscle strength
Time frame: Change from baseline (week 0) and to post-intervention (week 13)
Change in upper body muscle strength
Time frame: Change from baseline (week 0) to 4 months follow-up (week 29)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 38095797Bohn S, Oldervoll LM, Reinertsen KV, Seland M, Fossa A, Kiserud C, Skaali T, Nilsen TS, Blomhoff R, Henriksen HB, Lie HC, Berge T, Fjerstad E, Wisloff T, Slott M, Zajmovic I, Thorsen L. The feasibility of a multidimensional intervention in lymphoma survivors with chronic fatigue. Support Care Cancer. 2023 Dec 14;32(1):22. doi: 10.1007/s00520-023-08204-5.
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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.
Lene Thorsen principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 12-week interdisciplinary complex intervention in people with Fatigue and Lymphoma, 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 5 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: finished, as of the sponsor's last update on 21 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment rate (time frame: The week before the intervention period (week 0)). The study lists 27 primary outcomes in all. 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 NCT04931407, 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 21 Apr 2022.