Clinical trial · Interventional
CBT on Fatigue in Survivors of Hodgkin Lymphoma
Cognitive Behavioral Therapy (CBT) Web-based Intervention on Fatigue in Survivors of Hodgkin Lymphoma - a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Therapy for Treating Fatigue | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cognitive Behavioral Therapy for Treating Fatigue
- description
- This is the patient group that receives the intervention (IG), i.e., the cognitive behavioral therapy for reducing fatigue.
- interventionNames
- Behavioral: Cognitive Behavioral Therapy for Treating Fatigue
Primary outcomes (4)
- measure
- Response rate
- timeFrame
- 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.
- description
- 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.
- measure
- Patient adherence
- timeFrame
- During the intervention phase for each patient, which will be about sixth months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 \[1, 16\]. Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDEsser 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. PMID 36808045