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

Phase 3

Withdrawn

• Conditions: Distress in Caregivers of Cancer Patients
• Interventions: Behavioral: Individual treatment as usual; Behavioral: Tailored group intervention (PREPARE)

• Registration Number: NCT02739243
• Lead Sponsor: Heidelberg University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Individual 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.
Tailored group intervention	Tailored group intervention (PREPARE)	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

Primary Outcome Measures

Name	Time	Method
Distress	change from baseline distress at 1 week post treatment	measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C)

Secondary Outcome Measures

Name	Time	Method
General distress	change from baseline general distress at 1 week post treatment and at 6 months post treatment	measured using the Distress Thermometer (NCCN DT)
Unmet needs	change from baseline unmet needs at 1 week post treatment and at 6 months post treatment	measured using the Supportive Care Needs Survey - Partners \& Caregivers (SCNS-P\&C-G)
Self-efficacy in coping with the cancer disease	change from baseline self-efficacy at 1 week post treatment and at 6 months post treatment	measured using the adapted General Perceived Self-Efficacy Scale
Depression	change from baseline depression at 1 week post treatment and at 6 months post treatment	measured using the Patient Health Questionnaire-9 (PHQ-9)
Anxiety	change from baseline anxiety at 1 week post treatment and at 6 months post treatment	measured using the Generalized Anxiety Disorder-7 (GAD-7)
Utilisation of primary healthcare	change from baseline to 1 week post treatment and 6 months post treatment	measured via the number of visits with the individual primary care physician
Positive bonding with the group	change from baseline bonding at 1 week post treatment and 6 months post treatment	measured via the Positive Bonding Scale of the Group Questionnaire (GQ-D)