Hodgkin LymphomaNCT03968250
CBT on Fatigue in Survivors of Hodgkin Lymphoma
A study testing Cognitive Behavioral Therapy for Treating Fatigue in people with Hodgkin Lymphoma and Fatigue, run by University of Leipzig at 2 sites in Germany.
Trial summary
Background: Cancer-related fatigue is one of the most common patient-reported impairments in survivors of Hodgkin lymphoma and is associated with adverse effects on psychological well-being and everyday life including family, work and social participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Fatigue
- What is being tested?
- Cognitive Behavioral Therapy for Treating Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesGermany
- Study dates
- 20 Aug 2018to 15 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fluency in German language
- able to access the internet and use and follow a web-based Cognitive Behavioral intervention
- in complete remission after treatment for newly diagnosed HL without signs of relapse (no previous relapse)
- clinically relevant fatigue symptoms enduring at least 12 months after end of treatment (QLQ-C30 FA-12 ≥ 30 over at least two time points within the previous assessments in the course of the GHSG-trials)
- fatigue being related to HL and its treatment and interferes with usual functioning, i.e. fulfills the definition of CRF [1, 16].
Who cannot join
- Major communication difficulties
- severe cognitive impairment that would interfere with a patient's ability to give informed consent for research (indicated by the medical care team)
- Karnofsky Performance Status scale score < 70 predicting an expected survival of less than 6 months
- somatic co-morbidities that could explain the presence of severe fatigue (e.g. Chronic Obstructive Pulmonary Disease or heart failure) according to the hemato-oncologists examining the potential participant before inclusion for the study
- history of relapsed or refractory HL
- clinical symptoms which may indicate a relapse of HL
Show all 11Show fewer
- current depressive disorder and related psychotropic or psychological treatment
- Currently receiving medical and/or psychological treatment for a psychiatric disorder, other than the use of an anti-depressant
- current treatment aimed at fatigue
- previous attempt to treat fatigue with behavioral psychological therapy
- pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Cologne
Cologne
University Medical Center Leipzig
Leipzig, Saxony, 04103
About this study
Official title: Cognitive Behavioral Therapy (CBT) Web-based Intervention on Fatigue in Survivors of Hodgkin Lymphoma - a Pilot Study
Background: Cancer-related fatigue is one of the most common patient-reported impairments in survivors of Hodgkin lymphoma and is associated with adverse effects on psychological well-being and everyday life including family, work and social participation.
Methods: The investigators here present a bi-centric (Cologne and Leipzig) pilot-study for a web-based intervention (Cognitive Behavioral Therapy) on cancer-related fatigue. In detail, the investigators will conduct a non-randomized and non-controlled before-and-after study in a minimum of 20 survivors of Hodgkin lymphoma. Levels of fatigue and quality of life will be measured before the intervention (T0), post-intervention (T1) and at 3-months follow-up (T2).
Read more
Results: The investigators will provide information regarding the feasibility of the intervention (i.e., response rate, patient and therapist adherence, and patient satisfaction) and preliminary results on the efficacy of the program in reducing CRF and increasing levels of quality of life.
Aims: The results of this pilot-study will provide essential information to conduct a future randomized clinical trial to investigate the efficacy of this intervention in reducing cancer-related fatigue in survivors with Hodgkin lymphoma.
Read the detailed description
Concrete Aims: The investigators aim to conduct a a feasibility study, e.g., a pilot study before a randomized controlled trial can be planned in detail. This initial pilot-study is intended to test out the standard operating procedures, evaluate the feasibility, acceptance and adherence to the study protocol as well as preliminary efficacy of the web-based intervention for survivors of Hodgkin lymphoma. In detail, this study contains all preparation for conducting a trial, i.e., the translation, the adaptation and evaluation of the cognitive-behavioral web-based intervention manual from the original Dutch Version, the adaptation and implementation of all necessary technical and research-administrative requirements to successfully conduct the web-based randomized controlled trial and the evidence-based training of all study therapists including the implementation of therapists supervision. The investigators further assess adherence of the patients and therapists, the response rate and the patient satisfaction. Furthermore, preliminary efficacy of the intervention will be tested assessing levels of fatigue and quality of life at each measurement point.
Study Design: The design of this pilot web-based intervention on treating fatigue will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group that receives the intervention. No control group will be recruited. Assessments will be conducted on the three measurement points: before the therapy (T0), after the intervention (T1) and 3 months after the intervention (T2).
Intervention: The internet-based cognitive behavioral therapy on postcancer fatigue includes two face-to-face sessions with their therapist and eight web-based treatment modules, each approximately 45 minutes in length, delivered over 6 months. The intervention will be specifically tailored to the individual needs of each patient: The therapy model of cancer-related fatigue distinguishes six perpetuating factors: 1) insufficient processing of being diagnosed with Hodgkin lymphoma and being treated for it; 2) excessive fear of disease recurrence; 3) inactivity or a dysregulated (physical) activity pattern; 4) dysfunctional fatigue-related beliefs; 5) dysregulated sleep-wake pattern and 6) lack of social support. For each of these six cognitive-behavioural factors that can perpetuate fatigue a treatment module has been developed. The intervention will consist of a maximum of eight treatment modules: aside from the six modules addressing the fatigue maintaining factor there is a module on goal formulation and realization of goals.
Recruitment: the recruitment will be realized on the basis of two ongoing trials of the German Hodgkin study group (HD 16- HD18) where fatigue of the patients is measured continuously.
Duration: The duration for patients will be 9 months (6 months intervention, 3 month-follow-up assessment). The duration of the whole study will be 18 months.
- Conditions
- Hodgkin Lymphoma, Fatigue
- Being tested
- Cognitive Behavioral Therapy for Treating Fatigue
- Medical subject headings
- Hodgkin Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Treating FatigueBehavioural
The internet-based CBT postcancer fatigue intervention includes two face-to-face sessions with their therapist and eight web-based treatment modules, each approximately 45 minutes in length, delivered over 6 months.
The intervention will be specifically tailored to the individual needs of each patient: The CBT model of cancer-related fatigue distinguishes six perpetuating factors: 1) insufficient processing of being diagnosed with HL and being treated for it; 2) excessive fear of disease recurrence; 3) inactivity or a dysregulated (physical) activity pattern; 4) dysfunctional fatigue-related beliefs; 5) dysregulated sleep-wake pattern and 6) lack of social support. For each of these six cognitive-behavioural factors that can perpetuate fatigue a treatment module has been developed.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Treating Fatigue | Experimental | This is the patient group that receives the intervention (IG), i.e., the cognitive behavioral therapy for reducing fatigue. Receives: Behavioral: Cognitive Behavioral Therapy for Treating Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
Measured: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.
Patient adherence
Patient adherence will be assessed via documentation of patient drop-outs. In detail, we will document whether patients leave the study during the treatment (and if yes, at what stage).
Measured: During the intervention phase for each patient, which will be about sixth months.
Patient satisfaction
Assessed by a questionnaire (Working Alliance Inventory - short form revised). The total sum score across the 12 items, rated on a five-point Likert scale, will be presented (ranging from 12 to 60). Higher values present higher satisfaction.
Measured: Assessed only once for each patient, immediately after the patient has completed the intervention.
Therapist adherence
Using information of the therapy protocols of each participant, it will be assessed if the treatment sessions were done according to the treatment protocol.
Measured: Assessed during the intervention phase for each patient, i.e., within about 6 six months.
Secondary outcomes (3)
Levels of fatigue 1
Assessed by a questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Module Measuring Cancer-Related Fatigue (EORTC QLQ-FA12). The questionnaire assesses the level of cancer-related fatigue. The sum score across all 12 items, rated on a 4-point Likert scale, will be reported (total range: 12-48). Higher values indicate higher levels of fatigue (i.e., higher values indicate a worse outcome).
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Levels of fatigue 2
Levels of fatigue will additionally assessed by a second questionnaire, the Checklist Individual Strength - Subscale Fatigue Severity. The scale assesses the level of cancer-related fatigue. The sum score across all 8 items, rated on a 7-point Likert scale, will be presented (total range: 8 - 56). Higher values indicate higher levels of fatigue (i.e., higher values indicate a worse outcome).
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Global quality of life
Global quality of Life will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC), Quality of Life-questionnaire (EORTC QLQ-C30). Global quality of life is assessed in a 2-item subscale of the questionnaire, each rated on a 7-point-Likert scale (total range: 2-14). According to the questionnaire manual, however, the sum score of the two items will be linear-transformed to a 0-100 scale, with higher values indicating higher levels of quality of life (i.e., higher values indicate a better outcome).
Measured: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start20 Aug 2018
- Primary completion28 Feb 2021
- Study completion15 Mar 2021
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 Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The design of this pilot web-based CBT Fatigue therapy will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group that receives the intervention (IG). No control group will be recruited. Assessments will be conducted at three measurement points: T0 (before the intervention), T1 (at the end of the intervention), T2 (3 months after T1).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung e.V. (Germany), Medical University of Cologne
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Anja Mehnert, Prof. Dr., Principal investigator, University of LeipzigPeter Borchmann, Prof. Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968250
- Sponsor's protocol ID
- 933 000-146
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Esser P, Muller H, Borchmann P, Kreissl S, Knoop H, Platzbecker U, Vucinic V, Mehnert-Theuerkauf A. Web-Based Cognitive-Behavioral Therapy to Reduce Severe Cancer-Related Fatigue Among Survivors of Hodgkin Lymphoma: A Feasibility Study. J Clin Psychol Med Settings. 2023 Dec;30(4):856-865. doi: 10.1007/s10880-023-09944-6. Epub 2023 Feb 20.
PubMed 36808045
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy (CBT) Web-based Intervention on Fatigue in Survivors of Hodgkin Lymphoma - a Pilot Study
- ClinicalTrials.gov ID
- NCT03968250
- Acronym / sponsor ID
- 933 000-146
- Conditions
- Hodgkin Lymphoma, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Deutsche José Carreras Leukämie-Stiftung e.V. (Germany), Medical University of Cologne
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 30 May 2019 (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.
Background: Cancer-related fatigue is one of the most common patient-reported impairments in survivors of Hodgkin lymphoma and is associated with adverse effects on psychological well-being and everyday life including family, work and social participation.
Methods: The investigators here present a bi-centric (Cologne and Leipzig) pilot-study for a web-based intervention (Cognitive Behavioral Therapy) on cancer-related fatigue. In detail, the investigators will conduct a non-randomized and non-controlled before-and-after study in a minimum of 20 survivors of Hodgkin lymphoma. Levels of fatigue and quality of life will be measured before the intervention (T0), post-intervention (T1) and at 3-months follow-up (T2).
Results: The investigators will provide information regarding the feasibility of the intervention (i.e., response rate, patient and therapist adherence, and patient satisfaction) and preliminary results on the efficacy of the program in reducing CRF and increasing levels of quality of life.
Aims: The results of this pilot-study will provide essential information to conduct a future randomized clinical trial to investigate the efficacy of this intervention in reducing cancer-related fatigue in survivors with Hodgkin lymphoma.
Detailed description
Concrete Aims: The investigators aim to conduct a a feasibility study, e.g., a pilot study before a randomized controlled trial can be planned in detail. This initial pilot-study is intended to test out the standard operating procedures, evaluate the feasibility, acceptance and adherence to the study protocol as well as preliminary efficacy of the web-based intervention for survivors of Hodgkin lymphoma. In detail, this study contains all preparation for conducting a trial, i.e., the translation, the adaptation and evaluation of the cognitive-behavioral web-based intervention manual from the original Dutch Version, the adaptation and implementation of all necessary technical and research-administrative requirements to successfully conduct the web-based randomized controlled trial and the evidence-based training of all study therapists including the implementation of therapists supervision. The investigators further assess adherence of the patients and therapists, the response rate and the patient satisfaction. Furthermore, preliminary efficacy of the intervention will be tested assessing levels of fatigue and quality of life at each measurement point.
Study Design: The design of this pilot web-based intervention on treating fatigue will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group that receives the intervention. No control group will be recruited. Assessments will be conducted on the three measurement points: before the therapy (T0), after the intervention (T1) and 3 months after the intervention (T2).
Intervention: The internet-based cognitive behavioral therapy on postcancer fatigue includes two face-to-face sessions with their therapist and eight web-based treatment modules, each approximately 45 minutes in length, delivered over 6 months. The intervention will be specifically tailored to the individual needs of each patient: The therapy model of cancer-related fatigue distinguishes six perpetuating factors: 1) insufficient processing of being diagnosed with Hodgkin lymphoma and being treated for it; 2) excessive fear of disease recurrence; 3) inactivity or a dysregulated (physical) activity pattern; 4) dysfunctional fatigue-related beliefs; 5) dysregulated sleep-wake pattern and 6) lack of social support. For each of these six cognitive-behavioural factors that can perpetuate fatigue a treatment module has been developed. The intervention will consist of a maximum of eight treatment modules: aside from the six modules addressing the fatigue maintaining factor there is a module on goal formulation and realization of goals.
Recruitment: the recruitment will be realized on the basis of two ongoing trials of the German Hodgkin study group (HD 16- HD18) where fatigue of the patients is measured continuously.
Duration: The duration for patients will be 9 months (6 months intervention, 3 month-follow-up assessment). The duration of the whole study will be 18 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of this pilot web-based CBT Fatigue therapy will be a non-randomised prospective non-controlled before-and-after study, in which observations will be made only in a patient group that receives the intervention (IG). No control group will be recruited. Assessments will be conducted at three measurement points: T0 (before the intervention), T1 (at the end of the intervention), T2 (3 months after T1).
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Treating Fatigue | Experimental | Behavioral: Cognitive Behavioral Therapy for Treating FatigueThis is the patient group that receives the intervention (IG), i.e., the cognitive behavioral therapy for reducing fatigue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- fluency in German language
- able to access the internet and use and follow a web-based Cognitive Behavioral intervention
- in complete remission after treatment for newly diagnosed HL without signs of relapse (no previous relapse)
- clinically relevant fatigue symptoms enduring at least 12 months after end of treatment (QLQ-C30 FA-12 ≥ 30 over at least two time points within the previous assessments in the course of the GHSG-trials)
- fatigue being related to HL and its treatment and interferes with usual functioning, i.e. fulfills the definition of CRF [1, 16].
Key exclusion criteria (11 listed)
- Major communication difficulties
- severe cognitive impairment that would interfere with a patient's ability to give informed consent for research (indicated by the medical care team)
- Karnofsky Performance Status scale score < 70 predicting an expected survival of less than 6 months
- somatic co-morbidities that could explain the presence of severe fatigue (e.g. Chronic Obstructive Pulmonary Disease or heart failure) according to the hemato-oncologists examining the potential participant before inclusion for the study
- history of relapsed or refractory HL
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Treating FatigueThe internet-based CBT postcancer fatigue intervention includes two face-to-face sessions with their therapist and eight web-based treatment modules, each approximately 45 minutes in length, delivered over 6 months. The intervention will be specifically tailored to the individual needs of each patient: The CBT model of cancer-related fatigue distinguishes six perpetuating factors: 1) insufficient processing of being diagnosed with HL and being treated for it; 2) excessive fear of disease recurrence; 3) inactivity or a dysregulated (physical) activity pattern; 4) dysfunctional fatigue-related beliefs; 5) dysregulated sleep-wake pattern and 6) lack of social support. For each of these six cognitive-behavioural factors that can perpetuate fatigue a treatment module has been developed. | Behavioural | Cognitive Behavioral Therapy for Treating Fatigue |
Primary outcome
Response rate
Time frame: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
Patient adherence
Time frame: During the intervention phase for each patient, which will be about sixth months.
Patient adherence will be assessed via documentation of patient drop-outs. In detail, we will document whether patients leave the study during the treatment (and if yes, at what stage).
Patient satisfaction
Time frame: Assessed only once for each patient, immediately after the patient has completed the intervention.
Assessed by a questionnaire (Working Alliance Inventory - short form revised). The total sum score across the 12 items, rated on a five-point Likert scale, will be presented (ranging from 12 to 60). Higher values present higher satisfaction.
Therapist adherence
Time frame: Assessed during the intervention phase for each patient, i.e., within about 6 six months.
Using information of the therapy protocols of each participant, it will be assessed if the treatment sessions were done according to the treatment protocol.
3 secondary outcomes
Levels of fatigue 1
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Levels of fatigue 2
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
Global quality of life
Time frame: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
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 28 Apr 2021.
- Derived from this study: PubMed 36808045Esser P, Muller H, Borchmann P, Kreissl S, Knoop H, Platzbecker U, Vucinic V, Mehnert-Theuerkauf A. Web-Based Cognitive-Behavioral Therapy to Reduce Severe Cancer-Related Fatigue Among Survivors of Hodgkin Lymphoma: A Feasibility Study. J Clin Psychol Med Settings. 2023 Dec;30(4):856-865. doi: 10.1007/s10880-023-09944-6. Epub 2023 Feb 20.
- Individual participant dataSharing planned: No
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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.
Anja Mehnert, Prof. Dr. principal investigator
University of Leipzig
Peter Borchmann, Prof. Dr. principal investigator
University of Cologne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Treating Fatigue in people with Hodgkin Lymphoma and Fatigue, run by University of Leipzig at 2 sites in Germany.
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 11 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Response rate (time frame: The assessment period for this outcome will be from the start of recruitment until the inclusion of the last patient, which will be about 1 year.). The study lists 4 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 NCT03968250, 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 28 Apr 2021.