A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients
- Conditions
- Distress in Caregivers of Cancer Patients
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Inability to give informed consent
- Insufficient German language knowledge
- Cognitive impairment impeding handling of questionnaires
- Severe psychiatric disease (acute psychosis or acute suicidality)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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)