Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors
Primary Purpose
Existential Suffering, Meaning of Life, Cognitive Function
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Reminiscence-Based Life Review
Sponsored by
About this trial
This is an interventional supportive care trial for Existential Suffering
Eligibility Criteria
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
Sites / Locations
- School of Nursing, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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 subjects allocated in the Control group will not receive any intervention.
Outcomes
Primary Outcome Measures
Purpose in life
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).
Secondary Outcome Measures
Cognitive function
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.
Psychological distress
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.
Perceived social support
MSPSS (Multidimensional Scale of Perceived Social Support): 12 items; Likert scale
Full Information
NCT ID
NCT05525299
First Posted
August 26, 2022
Last Updated
July 25, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05525299
Brief Title
Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors
Official Title
The Effects of a Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Existential Suffering, Meaning of Life, Cognitive Function, Psychological Distress, Social Support
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The subjects allocated in the Control group will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Reminiscence-Based Life Review
Intervention Description
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.
Primary Outcome Measure Information:
Title
Purpose in life
Description
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).
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Cognitive function
Description
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.
Time Frame
up to 6 weeks
Title
Psychological distress
Description
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.
Time Frame
up to 6 weeks
Title
Perceived social support
Description
MSPSS (Multidimensional Scale of Perceived Social Support): 12 items; Likert scale
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mu-Hsing Ho, PhD
Phone
+852 39102787
Email
mhbho@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Kelvin Chow, BSc
Phone
+852 92186066
Email
chowkayu@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mu-Hsing Ho, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mu-Hsing Ho, PhD
Phone
+852 39102787
Email
mhbho@hku.hk
First Name & Middle Initial & Last Name & Degree
Kelvin Chow, BSc
Phone
+852 92186066
Email
chowkayu@hku.hk
First Name & Middle Initial & Last Name & Degree
Mu-Hsing Ho, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors
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