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Cognitive Behavioral Therapy (CBT) on Fatigue

AcronymISRCTNEudraCTClinicaltrials.govDRKS

Cognitive Behavioral Therapy (CBT) web-based Intervention on Fatigue in survivors of Hodgkin Lymphoma – RCT pilot study

Status: Active

Purpose / Objectives

Primary Outcome

  • organizational issues and the feasibility of the intervention in order to better plan a future RCT
  • measures of patient recruitment
  • patient adherence and attrition
  • patient satisfaction with the intervention
  • experience and adherence of the treatment providers

Secondary Outcomes

  • Preliminary results concerning the efficacy of the intervention in reducing fatigue and improving quality of life (outcome measure: EORTC QLQ-FA12, EORTC QLQ-C30)

Diagnosis

Patient attributes

Inclusion criteria

  • 18 years of age or older
  • fluency in German language
  • able to access the internet and use and follow a web-based CBT intervention
  • able to provide written informed consent
  • in complete remission after treatment for newly diagnosed HL without signs of relapse (no previous relapse)
  • HL treatment has ended at least 18 months ago (no spontaneous recovery of fatigue is to be expected to occur after this period)
  • 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

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. COPD 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; to diagnose depression, all potential participants are screened with the PHQ-9; all patients scoring relatively high on that screener (sum score > 9) will be further assessed via a structured clinical interview (SCID-5)
  • 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 design

  • Phase IIa
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

  • 10 sessions (45 minutes each) over 6 months
    • the first and the last session are conducted face to face
    • 8 sessions are web-based using a specifically programmed web-page

Documents (password protected)

Responsibilities in overall trial

Deutsche Hodgkin Studiengruppe

Study Sites

Klinik I für Innere Medizin

Status

Active

Principal Investigator

Prof. Dr. med. Peter Borchmann

Deputy of Principal Investigator

  • Dr. Stefanie Kreissl

Contact at Site