A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534386
• Other study ID #: UW20-100
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: The University of Hong Kong
• Contact: Wendy Wing Tak Lam, PhD
• Phone: +852 39179878
• Email: wwtlam[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Weight Management

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic data	Demographic data including age, gender, marital status, education level, occupation and monthly family income will be assessed by self-reported questionnaire.	Baseline
Other	Clinical data	Clinical data will be extracted from medical records.	Baseline, 4-months post-baseline, and 12 months post-baseline
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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