The Effect of a Psycho-education Support Group TherapyNCT02120183
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
A study testing Psycho-educational support group therapy in people with The Effect of a Psycho-education Support Group Therapy, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- The Effect of a Psycho-education Support Group Therapy
- What is being tested?
- Psycho-educational support group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Cancer Institute, Singapore
Singapore, Singapore, 119074
Rathi Mahendran, (+65) 67723893, rathi_mahendran@nuhs.edu.sg
About this study
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.
Read the 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.
- Being tested
- Psycho-educational support group therapy
- Keywords
- Caregivers, Quality of life, Neoplasms, Psychotherapy, group, Family, Adaptation, psychological, Psycho-educational support group therapy, Cancer patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational support group therapyBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Psycho-educational support group therapy | Experimental | 4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role Receives: Behavioral: Psycho-educational support group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Quality of Life Index - Cancer
Measured: 4 weeks
Perceived Stress Scale
Measured: 4 weeks
Hospital Anxiety and Depression Scale
Measured: 4 weeks
Basic Psychological Needs Scale
Measured: 4 weeks
Healthcare Climate Questionnaire
Measured: 4 weeks
Perceived Competence Scale
Measured: 4 weeks
Interpersonal Support Evaluation List
Measured: 4 weeks
Benefit Finding
Measured: 4 weeks
Satisfaction and Feedback Questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for The Effect of a Psycho-education Support Group TherapyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Rathi Mahendran, Principal investigator, Department of Psychological Medicine, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120183
- Sponsor's protocol ID
- NR13NMR139MP
- Status last verified
- Jul 2014
- First submitted
- 17 Apr 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20014159Soothill 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.
PubMed 11846826Mahendran 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.
PubMed 28114962Mahendran 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.
PubMed 26586322
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
- ClinicalTrials.gov ID
- NCT02120183
- Acronym / sponsor ID
- NR13NMR139MP
- Keywords
- Caregivers, Quality of life, Neoplasms, Psychotherapy, group, Family, Adaptation, psychological, Psycho-educational support group therapy, Cancer patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycho-educational support group therapy | Experimental | Behavioral: Psycho-educational support group therapy4 week psycho-educational support group focusing on topics specific to psychosocial and emotional aspects of the cancer caregiving role |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-educational support group therapyWeekly 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) | Behavioural | Psycho-educational support group therapy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Background: PubMed 20014159Stenberg 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.
- Background: PubMed 11846826Soothill 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.
- Derived from this study: PubMed 28114962Mahendran 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.
- Derived from this study: PubMed 26586322Mahendran 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rathi Mahendran principal investigator
Department of Psychological Medicine, National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-educational support group therapy in people with The Effect of a Psycho-education Support Group Therapy, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joyce Tan ((+65) 67724516, joyce_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Quality of Life Index - Cancer (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02120183, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.