PREPARE – A clinical trial on a group treatment for distressed caregivers of cancer patients
| ISRCTN | ISRCTN22231701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22231701 |
| ClinicalTrials.gov number | NCT02739243 |
| Secondary identifying numbers | S-655/2015 |
- Submission date
- 31/03/2016
- Registration date
- 07/04/2016
- Last edited
- 13/02/2020
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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.
Who can participate?
Adult carers of patients who have been diagnosed with cancer in the last six months.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the tailored group therapy program, over a course of five sessions spread over eight weeks. The sessions are structured group talks and discussions which revolve around pre-specified themes: coping and acceptance, distress, handling cancer-related stressful situations, self-care and a final session for stabilisation. Those in the second group receive a leaflet containing brief information about what individual counselling services are available. One week after the eight week treatment period and again six months later, participants in both groups complete a number of questionnaires in order to find out if their distress levels are lower as well as how well they are coping.
What are the possible benefits and risks of participating?
It is possible that caregivers who take part in the tailored group therapy program will benefit from lower levels of distress and improved coping. There are no notable risks involved with taking part in this study.
Where is the study run from?
Heidelberg University Hospital (Germany)
When is the study starting and how long is it expected to run for?
February 2016 to August 2017
Who is funding the study?
Heidelberg University (Germany)
Who is the main contact?
Dr Markus W. Haun
markus.haun@med.uni-heidelberg.de
Contact information
Scientific
Department of General Internal Medicine and Psychosomatics
Heidelberg University Hospital
Heidelberg
D-69120
Germany
 ORCID ID |
0000-0003-1851-3747 |
|---|---|
| Phone | +49 6221 56 38 39 6 |
| markus.haun@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (in German) |
| Scientific title | Addressing the hidden patient - A randomised-controlled trial of a tailored group intervention for caregivers of cancer patients |
| Study acronym | PREPARE |
| Study objectives | A caregiver-specific group intervention is significantly more effective in reducing disease-related distress than treatment as usual that includes brief information and individual referral to the local outpatient counselling centre. |
| Ethics approval(s) | Institutional Review Board of the Medical Faculty Heidelberg, 08/02/2016, ref: S-129/2015 |
| Health condition(s) or problem(s) studied | Disease-specific distress in caregivers of cancer patients |
| Intervention | Gender-stratified 1:1 randomisation with allocation concealment (computed-assisted randomisation in RANDI2 by a blinded data manager). Total treatment duration is eight weeks for both groups. Follow-up for both study arms is at 1-week and 6-months post treatment. Experimental condition: 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 Control condition: 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. Participants in both groups are followed up 1 week and 6 months post-treatment. |
| Intervention type | Behavioural |
| Primary outcome measure | Distress is measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C) at baseline, 1 week, and 6 months post treatment. |
| Secondary outcome measures | 1. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 1 week, and 6 months post treatment 2. Anxiety is measured using the Generalized Anxiety Disorder-7 (GAD-7) at baseline, 1week, and 6 months post treatment 3. General distress is measured using the Distress Thermometer (NCCN DT) at baseline, 1week, and 6 months post treatment 4. Unmet needs are measured using the Supportive Care Needs Survey – Partners & Caregivers (SCNS-P&C-G) at baseline, 1 week, and 6 months post treatment 5. Self-effficacy in coping with the cancer disease is measured using the adapted General Perceived Self-Efficacy Scale, Positive Bonding Scale of the Group Questionnaire (GQ-D) at baseline, 1 week, and 6 months post treatment 6. Utilisation of primary healthcare is measured via the number of visits with the individual primary care physician at baseline, 1-week, and 6-months post treatment |
| Overall study start date | 01/02/2016 |
| Completion date | 30/08/2017 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 15/04/2016 |
| Date of final enrolment | 14/05/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 410
Heidelberg
D-69120
Germany
Sponsor information
University/education
Heidelberg University Hospital
Im Neuenheimer Feld 410
Heidelberg
D-69120
Germany
| Website | https://www.klinikum.uni-heidelberg.de/innere2 |
|---|---|
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/02/2020: ClinicalTrials.gov number added.
18/10/2017: Internal review.
26/10/2016: This study has been withdrawn as of October 24th, 2016 due to enrolment slower than anticipated accrual. Actual number of enrolled participants was zero.
