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NCT Number: NCT05534386

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital-Breast Center, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer survivorship care intervention

Behavioral

A one-off face-to-face assessment and personal advice by members of a multidisciplinary team

Step-up targeted personalized intervention

Behavioral

To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.

First stage control intervention

Behavioral

A set of skill-based pamphlets will be given.

Second stage control intervention

Behavioral

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

Primary outcomes

  1. Proportion of symptom distress caseness (distress prevalence)

    Time frame: 4-months post-baseline

    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.

  2. Proportion of patients with suboptimal weight control

    Time frame: 4-months post-baseline

    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.

  3. Change in total score of health-related quality of life

    Time frame: Baseline and 4-months post-baseline

    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.

Secondary outcomes

  1. Change in total scores of self-efficacy

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    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.

  2. Fear of cancer recurrence

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    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.

  3. Illness perception

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).

  4. Proportion of symptom distress caseness (distress prevalence)

    Time frame: 12-months post-baseline

    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.

  5. Proportion of patients with suboptimal weight control

    Time frame: 12-months post-baseline

    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.

  6. Health state

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    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.

Other outcomes

  1. Demographic data

    Time frame: Baseline

    Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire.

  2. Clinical data

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    Clinical data will be extracted from medical records.

  3. Lifestyle behavior

    Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline

    Lifestyle behavior e.g. drinking and smoking habit will be assessed using a single item question.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendy Wing Tak Lam, PhD

CONTACT

[email protected]

+852 39179878

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 9, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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