A Self-management Based Survivorship Intervention for Chinese Cancer Survivors
NCT ID: NCT05534386
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
486 participants
INTERVENTIONAL
2023-04-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Second stage intervention: We will use a block randomization with randomly permuted block sizes of 2,4, and 6 to ensure close balance of the numbers in each arm. Participants will be randomised to continue in the trial as usual (i.e. those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlets) or to attend a step-up targeted personalized intervention.
TREATMENT
QUADRUPLE
The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
Study Groups
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First stage intervention: Cancer survivorship care intervention (CSCI)
Patients randomized to the CSCI will attend a 120-minutes survivorship clinic in which each participant will be assessed by members a multidisciplinary team comprising a registered nurse, a dietitian, an exercise physiologist and a psychologist/counsellor. During the visit, participants will receive a personalized (1) treatment summary, (2) assessment and recommendation on managing physical and psychological symptoms, (3) assessment and recommendation on dietary advice, (4) assessment and recommendation on physical activity, and (5) advice on managing potential psychosocial issues. While this is a multidisciplinary clinic, the nurse will be the core facilitator who will give a summary of health assessment report including personalized healthy lifestyle advice and action plan to each participant at the end of the visit.
Cancer survivorship care intervention
A one-off face-to-face assessment and personal advice by members of a multidisciplinary team
First stage intervention: Control intervention
Patients randomized to the control group will be given a set of pamphlets explaining symptoms and describing skill-based self-management for symptom management and lifestyle recommendations. Each pamphlet addresses one of the 7 most commonly-reported symptoms (sleep difficulties, fatigue, neuropathy, pain, anxiety, depression, and fear of cancer recurrence) observed in Hong Kong cancer survivors, plus two on lifestyle recommendations (physical activity and healthy diet). All pamphlets are developed based on the self-management framework.
First stage control intervention
A set of skill-based pamphlets will be given.
Second stage intervention: Step-up targeted personalized intervention
The step-up targeted personalized intervention will adopt a multi-disciplinary approach but place more emphasis on coaching to enhance patient' skills to manage their symptom burden and weight control.
Step-up targeted personalized intervention
To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
Second stage intervention: Control intervention
Patients randomized to the control arm at the re-assessment at 4-months post-baseline will continue in the trial as usual (i.e. those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlets).
Second stage control intervention
Those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlet
Interventions
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Cancer survivorship care intervention
A one-off face-to-face assessment and personal advice by members of a multidisciplinary team
Step-up targeted personalized intervention
To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
First stage control intervention
A set of skill-based pamphlets will be given.
Second stage control intervention
Those in the survivorship clinic arm will be asked to follow the advice given by the multidisciplinary team in the initial visit and for those in the control arm will be asked to follow the advices printed in the skill-based self-management pamphlet
Eligibility Criteria
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Inclusion Criteria
* have completed primary and adjuvant treatment within the past six months
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Wendy Wing Tak Lam
Associate Professor
Principal Investigators
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Wendy Wing Tak Lam, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health, The University of Hong Kong
Locations
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Kwong Wah Hospital-Breast Center
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital-Department of oncology
Hong Kong, , Hong Kong
Prince of Wales Hospital-Department of Surgery
Hong Kong, , Hong Kong
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Hong Kong, , Hong Kong
Queen Mary Hospital-Department of Oncology
Hong Kong, , Hong Kong
Queen Mary Hospital-Department of Surgery
Hong Kong, , Hong Kong
Tung Wah Hospital-Department of Surgery
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UW20-100
Identifier Type: -
Identifier Source: org_study_id
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