Clinical trial NCT05534386: A Self-management Based Survivorship Intervention for Chinese Cancer Survivors
Official title: How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Symptom Distress
Weight Management
Neoplasms
Keywords: Physical symptom distress
Weight management
Self-efficacy in managing cancer
Health-related quality of life
Survivorship intervention
Sequential multiple assessment randomized controlled trial
psychooncology
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: First 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 the intervention group (i.e. Cancer survivorship care intervention) or control group (i.e. a set of pamphlets explaining symptoms and describing skill-based self-management for symptom management and lifestyle recommendations).

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.
Primary purpose: TREATMENT

Brief summary: This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.

Detailed description: This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.

Eligibility criteria: Inclusion Criteria:

* Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
* have completed primary and adjuvant treatment within the past six months

Exclusion Criteria:

* Patients diagnosed with metastatic cancer

Primary outcomes:
measure: Proportion of symptom distress caseness (distress prevalence)
timeFrame: 4-months post-baseline
measure: Proportion of patients with suboptimal weight control
timeFrame: 4-months post-baseline
measure: Change in total score of health-related quality of life
timeFrame: Baseline and 4-months post-baseline
Secondary outcomes:
measure: Change in total scores of self-efficacy
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
measure: Fear of cancer recurrence
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
measure: Illness perception
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
measure: Proportion of symptom distress caseness (distress prevalence)
timeFrame: 12-months post-baseline
measure: Proportion of patients with suboptimal weight control
timeFrame: 12-months post-baseline
measure: Health state
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
Other outcomes:
measure: Demographic data
timeFrame: Baseline
measure: Clinical data
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
measure: Lifestyle behavior
timeFrame: Baseline, 4-months post-baseline, and 12 months post-baseline
Locations:
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital-Breast Center
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital-Department of oncology
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Obstetrics & Gynaecology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Oncology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital-Department of Surgery
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital-Department of Surgery
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Wendy Wing Tak Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: