A Phase 3 interventional study of Tailored group intervention (PREPARE) and Individual treatment as usual in Distress in Caregivers of Cancer Patients, sponsored by Heidelberg University. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Heidelberg University · Phase 3, Interventional, and Treatment
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.
Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Tailored group intervention (PREPARE)
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.
Behavioral: Individual treatment as usual
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
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
Positive bonding with the group
measured via the Positive Bonding Scale of the Group Questionnaire (GQ-D)
Time frame: change from baseline bonding at 1 week post treatment and 6 months post treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Heidelberg University