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.
Condition or disease | Intervention/treatment | Phase |
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Hodgkin Lymphoma Fatigue | Behavioral: Cognitive Behavioral Therapy for Treating Fatigue | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Primary Purpose: | Supportive Care |
Official Title: | Cognitive Behavioral Therapy (CBT) Web-based Intervention on Fatigue in Survivors of Hodgkin Lymphoma - a Pilot Study |
Actual Study Start Date : | August 20, 2018 |
Actual Primary Completion Date : | February 28, 2021 |
Actual Study Completion Date : | March 15, 2021 |
Arm | Intervention/treatment |
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Experimental: Cognitive Behavioral Therapy for Treating Fatigue
This is the patient group that receives the intervention (IG), i.e., the cognitive behavioral therapy for reducing fatigue.
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Behavioral: Cognitive Behavioral Therapy for Treating Fatigue
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. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University Medical Center Leipzig | |
Leipzig, Saxony, Germany, 04103 | |
University Medical Center Cologne | |
Cologne, Germany |
Principal Investigator: | Anja Mehnert, Prof. Dr. | University of Leipzig | |
Principal Investigator: | Peter Borchmann, Prof. Dr. | University of Cologne |
Tracking Information | |||||||
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First Submitted Date ICMJE | August 24, 2018 | ||||||
First Posted Date ICMJE | May 30, 2019 | ||||||
Last Update Posted Date | April 28, 2021 | ||||||
Actual Study Start Date ICMJE | August 20, 2018 | ||||||
Actual Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | CBT on Fatigue in Survivors of Hodgkin Lymphoma | ||||||
Official Title ICMJE | Cognitive Behavioral Therapy (CBT) Web-based Intervention on Fatigue in Survivors of Hodgkin Lymphoma - a Pilot Study | ||||||
Brief 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. 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. |
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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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention 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)Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Cognitive Behavioral Therapy for Treating Fatigue
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. |
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Study Arms ICMJE | Experimental: Cognitive Behavioral Therapy for Treating Fatigue
This is the patient group that receives the intervention (IG), i.e., the cognitive behavioral therapy for reducing fatigue.
Intervention: Behavioral: Cognitive Behavioral Therapy for Treating Fatigue
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
17 | ||||||
Original Estimated Enrollment ICMJE |
20 | ||||||
Actual Study Completion Date ICMJE | March 15, 2021 | ||||||
Actual Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03968250 | ||||||
Other Study ID Numbers ICMJE | 933 000-146 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Anja Mehnert, University of Leipzig | ||||||
Study Sponsor ICMJE | University of Leipzig | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Leipzig | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |