A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Weight Management; Physical Symptom Distress
• Intervention / Treatment: Behavioral: Cancer survivorship care intervention; Behavioral: First stage control intervention; Behavioral: Step-up targeted personalized intervention; Behavioral: Second stage control intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Wing Tak Lam, PhD; Phone Number: +852 39179878; Email: wwtlam@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital-Department of Obstetrics & Gynaecology
    • Contact: Karen Chan; Email: kklchan@hku.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital-Department of Oncology
    • Contact: Wendy Chan; Email: winglok@hku.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital-Department of Surgery
    • Contact: Dominic Foo; Email: ccfoo@hku.hk
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Kwong Wah Hospital-Breast Center
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Pamela Youde Nethersole Eastern Hospital-Department of oncology
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Prince of Wales Hospital-Department of Surgery
  • Hong Kong, Hong Kong
    • Active, not recruiting
    • Tung Wah Hospital-Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Cancer survivorship care intervention; A one-off face-to-face assessment and personal advice by members of a multidisciplinary team
Active Comparator: 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.	Behavioral: First stage control intervention; A set of skill-based pamphlets will be given.
Experimental: 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.	Behavioral: Step-up targeted personalized intervention; To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
Active Comparator: 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).	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of symptom distress caseness (distress prevalence)	The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =>7 will be categorized as moderate-to-severe symptom distress cases.	4-months post-baseline
Proportion of patients with suboptimal weight control	Anthropometric measures include weight, height, and body composition, which will be measured in light clothing and without shoes. Weight and body composition including body fat, total body water, muscle mass, bone mass and BMI will be measured using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). Height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.	4-months post-baseline
Change in total score of health-related quality of life	The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) will assess health-related quality of life. The EORTC QLQ-C30 includes 30 items that measure five function scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptom items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulty.	Baseline and 4-months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total scores of self-efficacy	The process outcome is change in total scores of self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS) from baseline to 4-months post-baseline, and baseline to 12 months post-baseline. This is a 6-item scale assessing patients' confidence to perform six self-management behaviours. Each item is rated on a 10-point Likert scale. A high score indicates high self-efficacy.	Baseline, 4-months post-baseline, and 12 months post-baseline
Fear of cancer recurrence	The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.	Baseline, 4-months post-baseline, and 12 months post-baseline
Illness perception	Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).	Baseline, 4-months post-baseline, and 12 months post-baseline
Proportion of symptom distress caseness (distress prevalence)	The 13-items Edmonton Symptom Checklist (ESAS) will be used to assess symptom distress. The ESAS assesses 13 common symptoms, including pain, fatigue, sleep difficulties, numbness, worrying, feeling sad, or feeling nervous, using a 10-point Likert scale. Patients rating at least one symptom at =>7 will be categorized as moderate-to-severe symptom distress cases.	12-months post-baseline
Proportion of patients with suboptimal weight control	Anthropometric measures include weight, height, and body composition, which will be measured in light clothing and without shoes. Weight and body composition including body fat, total body water, muscle mass, bone mass and BMI will be measured using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). Height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.	12-months post-baseline
Health state	Health questionnaire (EQ-5D-5L) including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression will be used to assessed participants' health state. Each dimension has 5 levels from no problems, slight problems, moderate problems, severe problems to extreme problems. The EQ-5D-5L also records participants self-rated health on a vertical visual analogue scale, where higher values indicate better health the participants can imagine.	Baseline, 4-months post-baseline, and 12 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire.	Baseline
Clinical data	Clinical data will be extracted from medical records.	Baseline, 4-months post-baseline, and 12 months post-baseline
Lifestyle behavior	Lifestyle behavior e.g. drinking and smoking habit will be assessed using a single item question.	Baseline, 4-months post-baseline, and 12 months post-baseline

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Wendy Wing Tak Lam, PhD, School of Public Health, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Health-related quality of life; Weight management; Physical symptom distress; Self-efficacy in managing cancer; Survivorship intervention; Sequential multiple assessment randomized controlled trial; psychooncology
• Other Study ID Numbers: UW20-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No