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A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients (PREPARE)

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ClinicalTrials.gov Identifier: NCT02739243
Recruitment Status : Withdrawn (Enrolment slower than anticipated accrual.)
First Posted : April 15, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Markus Haun, 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.

Condition or disease Intervention/treatment Phase
Distress in Caregivers of Cancer Patients Behavioral: Tailored group intervention (PREPARE) Behavioral: Individual treatment as usual Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Tailored group intervention

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)
Active Comparator: Treatment as usual
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



Primary Outcome Measures :
  1. Distress [ Time Frame: 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 :
  1. Depression [ Time Frame: change from baseline depression at 1 week post treatment and at 6 months post treatment ]
    measured using the Patient Health Questionnaire-9 (PHQ-9)

  2. Anxiety [ Time Frame: change from baseline anxiety at 1 week post treatment and at 6 months post treatment ]
    measured using the Generalized Anxiety Disorder-7 (GAD-7)

  3. General distress [ Time Frame: change from baseline general distress at 1 week post treatment and at 6 months post treatment ]
    measured using the Distress Thermometer (NCCN DT)

  4. Unmet needs [ Time Frame: 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)

  5. Self-efficacy in coping with the cancer disease [ Time Frame: 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

  6. Utilisation of primary healthcare [ Time Frame: 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

  7. Positive bonding with the group [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739243


Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Markus W Haun, MD Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital

Responsible Party: Markus Haun, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT02739243     History of Changes
Other Study ID Numbers: S-655/2015
ISRCTN22231701 ( Registry Identifier: ISRCTN registry )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided