Existential SufferingNCT05525299
Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors
A study testing Reminiscence-Based Life Review in people with Existential Suffering and Meaning of Life, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Existential Suffering, Meaning of Life, Cognitive Function
- What is being tested?
- Reminiscence-Based Life Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Oct 2022to 30 Aug 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- Inadequate written and verbal Cantonese and/or English comprehension for study activities
- Diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong
Mu-Hsing Ho, PhD, +852 39102787, mhbho@hku.hk
Kelvin Chow, BSc, +852 92186066, chowkayu@hku.hk
About this study
Official title: 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.
Read more
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.
- Conditions
- Existential Suffering, Meaning of Life, Cognitive Function, Psychological Distress, Social Support
- Being tested
- Reminiscence-Based Life Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence-Based Life ReviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Reminiscence-Based Life Review |
| Control | No intervention | The subjects allocated in the Control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 6 weeks
Secondary outcomes (3)
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.
Measured: up to 6 weeks
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.
Measured: up to 6 weeks
Perceived social support
MSPSS (Multidimensional Scale of Perceived Social Support): 12 items; Likert scale
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start30 Oct 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Existential SufferingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu-Hsing Ho, The University of Hong Kong
- Investigators
- Mu-Hsing Ho, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525299
- Sponsor's protocol ID
- uhongkongw4fgupp4
- Status last verified
- Jul 2023
- First submitted
- 26 Aug 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05525299
- Acronym / sponsor ID
- uhongkongw4fgupp4
- Conditions
- Existential Suffering, Meaning of Life, Cognitive Function, Psychological Distress, Social Support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 1 Sep 2022 (actual)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Reminiscence-Based Life ReviewA 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. |
| Control | No intervention | –The subjects allocated in the Control group will not receive any intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Inadequate written and verbal Cantonese and/or English comprehension for study activities
- Diagnosed with dementia
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 |
|---|---|---|
| Reminiscence-Based Life ReviewThe 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. | Behavioural | Intervention |
Primary outcome
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).
3 secondary outcomes
Cognitive function
Time frame: up to 6 weeks
Psychological distress
Time frame: up to 6 weeks
Perceived social support
Time frame: up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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.
Mu-Hsing Ho, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence-Based Life Review in people with Existential Suffering and Meaning of Life, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 2 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 27 Jul 2023. 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 Hong Kong. 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 Mu-Hsing Ho, PhD (+852 39102787, mhbho@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purpose in life (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.