NCT05525299

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:

  1. 1.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
  2. 2.To explore older cancer survivors' experience of the intervention regarding the impact of the intervention on their existential suffering

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

August 26, 2022

Last Update Submit

July 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    up to 6 weeks

Secondary Outcomes (3)

  • Cognitive function

    up to 6 weeks

  • Psychological distress

    up to 6 weeks

  • Perceived social support

    up to 6 weeks

Study Arms (2)

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.

Behavioral: Reminiscence-Based Life Review

Control

NO INTERVENTION

The subjects allocated in the Control group will not receive any intervention.

Interventions

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.

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Inadequate written and verbal Cantonese and/or English comprehension for study activities
  • Diagnosed with dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Mu-Hsing Ho, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu-Hsing Ho, PhD

CONTACT

Kelvin Chow, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 1, 2022

Study Start

October 30, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations