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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
Sponsor:
Collaborator:
National University Cancer Institute, Singapore (NCIS)
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
This is a study to determine the effectiveness of a Group Therapy that provides psycho-education and support for caregivers of cancer patients. Caregivers must be between 21 and 64 years of age and be willing to attend a one-hour a week program for four weeks. The sessions will be in English, and a set of questionnaires (demographic data, some information about your family member with cancer, and scales: Caregiver Quality of Life-Cancer Scale (CQOLC), Perceived Stress Scale and the Hospital Anxiety Depression Scale (HADS)) will be completed at the start, at 4 weeks, at 8 weeks and at 12 weeks. Some participants placed on a wait-list to start the Group Therapy 4 weeks later will also complete the set of questionnaires at this point. A Feedback and Satisfaction Questionnaire will be completed at the end of the 4 week program. In addition, at the end of the 4 week program, some participants will go through a 15-minute interview.

Condition or disease Intervention/treatment Phase
The Effect of a Psycho-education Support Group Therapy Behavioral: Psycho-educational support group therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
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)





Primary Outcome Measures :
  1. Caregiver Quality of Life Index - Cancer [ Time Frame: 4 weeks ]
  2. Perceived Stress Scale [ Time Frame: 4 weeks ]
  3. Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
  4. Basic Psychological Needs Scale [ Time Frame: 4 weeks ]
  5. Healthcare Climate Questionnaire [ Time Frame: 4 weeks ]
  6. Perceived Competence Scale [ Time Frame: 4 weeks ]
  7. Interpersonal Support Evaluation List [ Time Frame: 4 weeks ]
  8. Benefit Finding [ Time Frame: 4 weeks ]
  9. Satisfaction and Feedback Questionnaire [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 21 to 64 years of age
  • Willingness to attend a 1-hour program every week for 4 weeks
  • Able to understand and speak basic English
  • Able to understand and complete self-report questionnaires with minimal assistance
  • Be the primary adult family member who provides care and support for the patient and lives together with the patient

Exclusion Criteria:

  • Younger than 21 years of age, or 65 years of age and older
  • Unable to understand and speak basic English
  • Unable to understand and complete self-report questionnaires with minimal assistance

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): NCT02120183


Contacts
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Contact: Joyce Tan (+65) 67724516 joyce_tan@nuhs.edu.sg

Locations
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Singapore
National University Cancer Institute, Singapore Recruiting
Singapore, Singapore, 119074
Contact: Rathi Mahendran    (+65) 67723893    rathi_mahendran@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
National University Cancer Institute, Singapore (NCIS)
Investigators
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Principal Investigator: Rathi Mahendran Department of Psychological Medicine, National University Health System
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02120183    
Other Study ID Numbers: NR13NMR139MP
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by National University Hospital, Singapore:
Caregivers
Quality of life
Neoplasms
Psychotherapy, group
Family
Adaptation, psychological
Psycho-educational support group therapy
Cancer patients