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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Cologne, Alemanha
- University Medical Center Cologne
-
-
Saxony
-
Leipzig, Saxony, Alemanha, 04103
- University Medical Center Leipzig
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Taxa de resposta
Prazo: O período de avaliação deste desfecho será desde o início do recrutamento até a inclusão do último paciente, que será de cerca de 1 ano.
|
Os investigadores avaliarão a quantidade de pacientes elegíveis que estão dispostos a participar do estudo em relação à quantidade de pacientes que foram convidados a participar.
|
O período de avaliação deste desfecho será desde o início do recrutamento até a inclusão do último paciente, que será de cerca de 1 ano.
|
|
Adesão do paciente
Prazo: Durante a fase de intervenção para cada paciente, que será de cerca de seis meses.
|
A adesão do paciente será avaliada por meio da documentação das desistências do paciente.
Em detalhes, documentaremos se os pacientes abandonam o estudo durante o tratamento (e se sim, em que estágio).
|
Durante a fase de intervenção para cada paciente, que será de cerca de seis meses.
|
|
Satisfação do paciente
Prazo: Avaliado apenas uma vez para cada paciente, imediatamente após o paciente ter concluído a intervenção.
|
Avaliado por um questionário (Working Alliance Inventory - versão abreviada revisada).
Será apresentada a pontuação total dos 12 itens, classificados em uma escala Likert de cinco pontos (variando de 12 a 60).
Valores mais altos apresentam maior satisfação.
|
Avaliado apenas uma vez para cada paciente, imediatamente após o paciente ter concluído a intervenção.
|
|
Therapist adherence
Prazo: 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.
|
Assessed during the intervention phase for each patient, i.e., within about 6 six months.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Levels of fatigue 1
Prazo: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
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).
|
Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
|
Levels of fatigue 2
Prazo: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
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).
|
Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
|
Global quality of life
Prazo: Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
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).
|
Assessed at three time points: before the intervention, immediately after the intervention and 3 months after the intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anja Mehnert, Prof. Dr., University of Leipzig
- Investigador principal: Peter Borchmann, Prof. Dr., University of Cologne
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 933 000-146
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .