CBT on Fatigue in Survivors of Hodgkin Lymphoma

NCT03968250 | Completed

• 1 other identifier: 933 000-146
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Hodgkin Lymphoma; Fatigue

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  Assessed during the intervention phase for each patient, i.e., within about 6 six months.

Secondary Outcomes (3)

• Levels of fatigue 1

  Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

• Levels of fatigue 2

  Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

• Global quality of life

  Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention

Study Arms (1)

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.

Behavioral: Cognitive Behavioral Therapy for Treating Fatigue

Interventions

Cognitive Behavioral Therapy for Treating Fatigue BEHAVIORAL

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.

Cognitive Behavioral Therapy for Treating Fatigue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[1, 16\].

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Leipzig: lead
• Deutsche José Carreras Leukämie-Stiftung e.V. (Germany): collaborator
• Medical University of Cologne: collaborator

Study Sites (2)

University Medical Center Leipzig

Leipzig, Saxony, 04103, Germany

Location

University Medical Center Cologne

Cologne, Germany

Location

Related Publications (1)

• 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.

  PMID: 36808045 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Fatigue

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anja Mehnert, Prof. Dr.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

• Peter Borchmann, Prof. Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Medical Psychology and Medical Sociology

Model Details: 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).

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: May 30, 2019
• Study Start: August 20, 2018
• Primary Completion: February 28, 2021
• Study Completion: March 15, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)