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

Heidelberg University

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Distress in Caregivers of Cancer Patients

Interventions

Tailored group intervention (PREPARE)BEHAVIORAL

Individual treatment as usualBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Distress

measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C)

Time frame: change from baseline distress at 1 week post treatment

Secondary Outcomes

Depression

measured using the Patient Health Questionnaire-9 (PHQ-9)

Time frame: 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)

Time frame: change from baseline anxiety at 1 week post treatment and at 6 months post treatment

General distress

measured using the Distress Thermometer (NCCN DT)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: change from baseline to 1 week post treatment and 6 months post treatment

Data from ClinicalTrials.gov

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