Distress in Caregivers of Cancer Patients Clinical Trial
— PREPAREOfficial title:
Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
| Verified date | October 2016 |
| Source | Heidelberg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Heidelberg University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |