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A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients

NCT ID: NCT02739243

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.

Detailed Description

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Conditions

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Distress in Caregivers of Cancer Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tailored group intervention

Participants take part in the tailored group intervention which consists of five 90-minute group sessions over eight weeks. The sessions are in the form of structured group talk/discussions following specific themes:

Session 1 - Coping and acceptance: identification of common themes from participants' feedback, provision of information about support services, mindfulness practices

Session 2 - Distress: introduction of the distress model, identification of resources, breathing practices

Session 3 - Handling of stressful situations: individual identification in tandems, discussion of common pitfalls in the group

Session 4 - Self-care: inspection of individual daily routines, group collects positive experiences with "windows" for self-care

Session 5 - Feedback and outlook: stabilisation, retrospective reflection on the group experience and its benefits and, if applicable, potential adverse events

Group Type EXPERIMENTAL

Tailored group intervention (PREPARE)

Intervention Type BEHAVIORAL

Treatment as usual

Participants are provided with brief information in a leaflet, about the possibilities for individual counselling including referral to the local outpatient cancer counselling centre providing client-centred counselling and financial social work.

Group Type ACTIVE_COMPARATOR

Individual treatment as usual

Intervention Type BEHAVIORAL

Interventions

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Tailored group intervention (PREPARE)

Intervention Type BEHAVIORAL

Individual treatment as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Time since initial diagnosis (of patient) not longer than six months previously
2. Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
3. Provision of informed consent
4. Aged 18 or over, either gender

Exclusion Criteria

1. Inability to give informed consent
2. Insufficient German language knowledge
3. Cognitive impairment impeding handling of questionnaires
4. Severe psychiatric disease (acute psychosis or acute suicidality)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Markus Haun

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus W Haun, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital

Other Identifiers

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ISRCTN22231701

Identifier Type: REGISTRY

Identifier Source: secondary_id

S-655/2015

Identifier Type: -

Identifier Source: org_study_id