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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Distress in Caregivers of Cancer Patients
• Intervention / Treatment: Behavioral: Tailored group intervention (PREPARE); Behavioral: Individual treatment as usual

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Markus W Haun, MD, Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: S-655/2015; ISRCTN22231701 (Registry Identifier: ISRCTN registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided