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

Study Overview
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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.

Official Title
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Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)

Conditions
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Distress in Caregivers of Cancer Patients

Intervention / Treatment
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* Behavioral: Tailored group intervention (PREPARE)
* Behavioral: Individual treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Time since initial diagnosis (of patient) not longer than six months previously Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points) Provision of informed consent Aged 18 or over, either gender Exclusion Criteria: Inability to give informed consent Insufficient German language knowledge Cognitive impairment impeding handling of questionnaires Severe psychiatric disease (acute psychosis or acute suicidality)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored group intervention<br>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 | Behavioral: Tailored group intervention (PREPARE)<br> <br> |
| Active Comparator: Treatment as usual<br>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. | Behavioral: Individual treatment as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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