Distress in Caregivers of Cancer Patients
Conditions
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.
Interventions
BEHAVIORALTailored group intervention (PREPARE)
BEHAVIORALIndividual treatment as usual
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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 |
Outcome results
None listed