Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
Primary Purpose
The Effect of a Psycho-education Support Group Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Psycho-educational support group therapy
Sponsored by
About this trial
This is an interventional supportive care trial for The Effect of a Psycho-education Support Group Therapy focused on measuring Caregivers, Quality of life, Neoplasms, Psychotherapy, group, Family, Adaptation, psychological, Psycho-educational support group therapy, Cancer patients
Eligibility 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
Sites / Locations
- National University Cancer Institute, SingaporeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psycho-educational support group therapy
Arm Description
4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role
Outcomes
Primary Outcome Measures
Caregiver Quality of Life Index - Cancer
Perceived Stress Scale
Hospital Anxiety and Depression Scale
Basic Psychological Needs Scale
Healthcare Climate Questionnaire
Perceived Competence Scale
Interpersonal Support Evaluation List
Benefit Finding
Satisfaction and Feedback Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02120183
First Posted
April 17, 2014
Last Updated
July 3, 2014
Sponsor
National University Hospital, Singapore
Collaborators
National University Cancer Institute, Singapore (NCIS)
1. Study Identification
Unique Protocol Identification Number
NCT02120183
Brief Title
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
Official Title
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National University Cancer Institute, Singapore (NCIS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Effect of a Psycho-education Support Group Therapy
Keywords
Caregivers, Quality of life, Neoplasms, Psychotherapy, group, Family, Adaptation, psychological, Psycho-educational support group therapy, Cancer patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psycho-educational support group therapy
Arm Type
Experimental
Arm Description
4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educational support group therapy
Intervention Description
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 Measure Information:
Title
Caregiver Quality of Life Index - Cancer
Time Frame
4 weeks
Title
Perceived Stress Scale
Time Frame
4 weeks
Title
Hospital Anxiety and Depression Scale
Time Frame
4 weeks
Title
Basic Psychological Needs Scale
Time Frame
4 weeks
Title
Healthcare Climate Questionnaire
Time Frame
4 weeks
Title
Perceived Competence Scale
Time Frame
4 weeks
Title
Interpersonal Support Evaluation List
Time Frame
4 weeks
Title
Benefit Finding
Time Frame
4 weeks
Title
Satisfaction and Feedback Questionnaire
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce Tan
Phone
(+65) 67724516
Email
joyce_tan@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rathi Mahendran
Organizational Affiliation
Department of Psychological Medicine, National University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Cancer Institute, Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rathi Mahendran
Phone
(+65) 67723893
Email
rathi_mahendran@nuhs.edu.sg
12. IPD Sharing Statement
Citations:
PubMed Identifier
20014159
Citation
Stenberg U, Ruland CM, Miaskowski C. Review of the literature on the effects of caring for a patient with cancer. Psychooncology. 2010 Oct;19(10):1013-25. doi: 10.1002/pon.1670.
Results Reference
background
PubMed Identifier
11846826
Citation
Soothill K, Morris SM, Harman JC, Francis B, Thomas C, McIllmurray MB. Informal carers of cancer patients: what are their unmet psychosocial needs? Health Soc Care Community. 2001 Nov;9(6):464-75. doi: 10.1046/j.0966-0410.2001.00326.x.
Results Reference
background
PubMed Identifier
28114962
Citation
Mahendran R, Lim HA, Tan JY, Ng HY, Chua J, Lim SE, Kua EH, Griva K. Evaluation of a brief pilot psychoeducational support group intervention for family caregivers of cancer patients: a quasi-experimental mixed-methods study. Health Qual Life Outcomes. 2017 Jan 23;15(1):17. doi: 10.1186/s12955-017-0595-y.
Results Reference
derived
PubMed Identifier
26586322
Citation
Mahendran R, Tan JY, Griva K, Lim HA, Ng HY, Chua J, Lim SE, Kua EH. A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol. BMJ Open. 2015 Nov 19;5(11):e008527. doi: 10.1136/bmjopen-2015-008527.
Results Reference
derived
Learn more about this trial
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
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