- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05525299
Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors
The Effects of a Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors With Cognitive Impairment
Target Issue:
Cognitive impairment in older cancer survivors is highly prevalent and the co-existing neuro-psychiatric symptoms, particularly depression, would further complicate the psychosocial consequence of existential suffering. However, no reminiscence-based interventions are specifically developed for older people with cancer have been developed and evaluated.
Target Population:
Cancer survivors aged 65 years old and above with a mild cognitive impairment identified by the HK-MoCA 5-Min Protocol cognitive assessment.
Intervention:
This research project aims to implement a brief reminiscence-based intervention that includes six reminiscence chatting sessions among older cancer survivors. The proposed reminiscence-based intervention has great potential to provide psychological and spiritual care as well as comfort to those who are weak, aged and are in need of assistance.
Study Objectives:
- To evaluate the effect of a reminiscence-based life review intervention on copying with existential suffering including meaning of life (primary outcome), cognitive function, psychological distress and social support (secondary outcomes) in older cancer survivors
- To explore older cancer survivors' experience of the intervention regarding the impact of the intervention on their existential suffering
Study Method:
The investigator will recruit 116 voluntary elder patients from the outpatient oncology clinics of the Queen Mary Hospital to participate in the study. They will be individually randomized at a 1:1 ratio to receive usual care or the brief reminiscence-based intervention at home. Outcomes will be assessed at baseline (T0), post-intervention (T1), and 6-week follow-up (T2). A qualitative interview regarding the feedback on the intervention will be undertaken only in the intervention group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mu-Hsing Ho, PhD
- Phone Number: +852 39102787
- Email: mhbho@hku.hk
Study Contact Backup
- Name: Kelvin Chow, BSc
- Phone Number: +852 92186066
- Email: chowkayu@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- School of Nursing, The University of Hong Kong
-
Contact:
- Mu-Hsing Ho, PhD
- Phone Number: +852 39102787
- Email: mhbho@hku.hk
-
Contact:
- Kelvin Chow, BSc
- Phone Number: +852 92186066
- Email: chowkayu@hku.hk
-
Principal Investigator:
- Mu-Hsing Ho, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged ≥ 65 years
- Diagnosed with stage I-III non-metastatic cancer
- Completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
- identified as mild cognitive impairment by the HK-MoCA 5-Min Protocol cognitive assessment (≤ 7th age and education corrected percentile cutoff score)
Exclusion Criteria:
- Inadequate written and verbal Cantonese and/or English comprehension for study activities
- Diagnosed with dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
A brief reminiscence-based life review with six themes to recall subjects' memory through the life review reminiscence intervention will be given.
A total of six reminiscence chatting sessions (30-60 minutes per session) covering these themes will be conducted weekly.
|
The reminiscence chatting activities covering 6 themes include: Week 1: "Instruction of the 'Life Story Narrative Journal' and My 'Childhood' memories" Week 2: "My 'Adolesces' memories and Memorable moments spent with my family" Week 3: "My 'Adulthood' memories and My very first full time job" Week 4: "My thoughts when I received my cancer diagnosis" Week 5: "My favourite activities before and after receiving a cancer diagnosis" Week 6: "When COVID-19 hits, _____ changes and The story goes on! The future pages are more to come!" A 'Life Story Narrative Journal' with six themes to recall subjects' memory through the life review reminiscence activities will be given. The Life Story Narrative Journal is a diary booklet that enables the participant to write down and express their thoughts in a narrative. |
|
No Intervention: Control
The subjects allocated in the Control group will not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purpose in life
Time Frame: up to 6 weeks
|
The purpose in life will be assessed by the Purpose in Life (PIL) Test developed by Crumbaugh and Maholick (1964), which considers the meaning of life as unique and personal for each individual and as changing throughout the life cycle.
The PIL test consists of 20 items that saturate four dimensions: perception of meaning (motives, reasons, and valuation of living life); experience of meaning (perception of one's own life and daily life as full of good things); goals and tasks (goals linked to concrete actions in life and perception of personal responsibility) and dialectic/destiny and freedom (tension between destiny and freedom and coping with death as an uncontrollable, unpredictable, and inevitable event).
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: up to 6 weeks
|
The objective cognitive function will be assessed by the HK-MoCA 5-Min Protocol cognitive assessment.
The HK-MoCA 5-Min Protocol includes four subtests examining five cognitive domains, namely attention, verbal learning and memory, executive functions/language, and orientation.
This measure can be alternatively done by a telephone interview and has excellent test-retest reliability, as well as highly correlated with original MoCA.
The self-reported cognitive function will be assessed by the FACT-Cog (Functional Assessment of Cancer Therapy - Cognitive Function) scale which consists of 37 items for detecting cancer-related cognitive impairment.
|
up to 6 weeks
|
|
Psychological distress
Time Frame: up to 6 weeks
|
The 21-item version of the Depression, Anxiety and Stress Scale (DASS-21) was used to assess mental well-being via core symptoms of depression, anxiety and stress.
Each subscale consists of seven self-report items that are each rated on a 4-point self-report scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time).
The subscales possess very good psychometric properties in an older population.
|
up to 6 weeks
|
|
Perceived social support
Time Frame: up to 6 weeks
|
MSPSS (Multidimensional Scale of Perceived Social Support): 12 items; Likert scale
|
up to 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mu-Hsing Ho, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- uhongkongw4fgupp4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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