Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life

NCT ID: NCT02120183

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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The Effect of a Psycho-education Support Group Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Psycho-educational support group therapy

Intervention Type BEHAVIORAL

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)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Singapore

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rathi Mahendran

Role: PRINCIPAL_INVESTIGATOR

Department of Psychological Medicine, National University Health System

Locations

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National University Cancer Institute, Singapore

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Joyce Tan

Role: CONTACT

(+65) 67724516

Facility Contacts

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Rathi Mahendran

Role: primary

(+65) 67723893

References

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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.

Reference Type BACKGROUND
PMID: 20014159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11846826 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28114962 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26586322 (View on PubMed)

Other Identifiers

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NR13NMR139MP

Identifier Type: -

Identifier Source: org_study_id

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