Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
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|ClinicalTrials.gov Identifier: NCT02120183|
Recruitment Status : Unknown
Verified July 2014 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : April 22, 2014
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|The Effect of a Psycho-education Support Group Therapy||Behavioral: Psycho-educational support group therapy||Not Applicable|
Participants Study participants are caregivers, recruited from the Medical Oncology Clinic (under NCIS) at NUH.
Intervention and Evaluation of the Psycho-educational Support Group Therapy This is a pre and post-intervention study with a control group design. The strength of this design is its experimental nature but without randomization, thereby avoiding the problems related to randomization. Instead, a wait-list is used as the control group.
Consecutive family caregivers who agree to participate will be placed in the first group (Group 1a) till a group size of ten is reached. The next ten will be put on a wait-list and form the control group (Group 1b), who will still be able to benefit from the program at a later time. In this manner subsequent treatment and control groups will be recruited.
The Intervention consists of weekly Psycho-educational Support Groups focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role. The Intervention is over a short duration of 4 weeks so as to appeal to caregivers and reduce the attrition rate. The proposed intervention is exploratory in nature but is hypothesized to be beneficial in helping to recognize and handle the difficult and often tumultuous journey of cancer caregiving. The planned Intervention was developed in discussions and consensus views using the Delphi method and adapted the brief integrative psychological therapy developed by Kua et al and psycho-educational programs at overseas centres. The CQOLC, the Perceived Stress Scale, and the HADS will be administered to participants at 4 time points: T1 (week 0), T2 (end of week 4), T3 (end of week 8) and T4 (end of week 12). The fourth time point is to evaluate whether the effects of the intervention are sustained. A Satisfaction and Feedback Questionnaire will be administered to participants at T2, immediately upon completion of the intervention. Some participants who have gone through the program will be invited to take part in a 15 minute interview. The purpose of the interview is to obtain feedback on the ways in which the program has been beneficial. The participants in the control group will complete a set of the same questionnaires when they are entered into the wait list; they will complete the questionnaires 5 times.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Psycho-educational support group therapy
4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role
Behavioral: Psycho-educational support group therapy
Weekly sessions lasting 60 minutes. Topics addressed each week:
Week 1: Coping with the diagnosis of loved one and dealing with uncertainty
Week 2: Caring for the carer 1: Feeding your body (self-care, stress management, mindfulness concepts)
Week 3: Caring for the carer 2: Feeding your mind (challenging negative thinking habits)
Week 4: The emotions of caregiving (handling emotional reactivity)
- Caregiver Quality of Life Index - Cancer [ Time Frame: 4 weeks ]
- Perceived Stress Scale [ Time Frame: 4 weeks ]
- Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
- Basic Psychological Needs Scale [ Time Frame: 4 weeks ]
- Healthcare Climate Questionnaire [ Time Frame: 4 weeks ]
- Perceived Competence Scale [ Time Frame: 4 weeks ]
- Interpersonal Support Evaluation List [ Time Frame: 4 weeks ]
- Benefit Finding [ Time Frame: 4 weeks ]
- Satisfaction and Feedback Questionnaire [ Time Frame: 4 weeks ]
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): NCT02120183
|Contact: Joyce Tan||(+65) firstname.lastname@example.org|
|National University Cancer Institute, Singapore||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Rathi Mahendran (+65) 67723893 email@example.com|
|Principal Investigator:||Rathi Mahendran||Department of Psychological Medicine, National University Health System|