A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

NCT05534386 | Recruiting

• 1 other identifier: UW20-100
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in total scores of self-efficacy

  Baseline, 4-months post-baseline, and 12 months post-baseline

• Fear of cancer recurrence

  Baseline, 4-months post-baseline, and 12 months post-baseline

• Illness perception

  Baseline, 4-months post-baseline, and 12 months post-baseline

• Proportion of symptom distress caseness (distress prevalence)

  12-months post-baseline

• Proportion of patients with suboptimal weight control

  12-months post-baseline

Other Outcomes (3)

• Demographic data

  Baseline

• Clinical data

  Baseline, 4-months post-baseline, and 12 months post-baseline

• Lifestyle behavior

  Baseline, 4-months post-baseline, and 12 months post-baseline

Study Arms (4)

First stage intervention: Cancer survivorship care intervention (CSCI)

EXPERIMENTAL

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

First stage intervention: Control intervention

ACTIVE COMPARATOR

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

Second stage intervention: Step-up targeted personalized intervention

EXPERIMENTAL

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

Second stage intervention: Control intervention

ACTIVE COMPARATOR

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

Interventions

Cancer survivorship care intervention BEHAVIORAL

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

First stage intervention: Cancer survivorship care intervention (CSCI)

Step-up targeted personalized intervention BEHAVIORAL

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

Second stage intervention: Step-up targeted personalized intervention

First stage control intervention BEHAVIORAL

A set of skill-based pamphlets will be given.

First stage intervention: Control intervention

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

Second stage intervention: Control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients diagnosed with metastatic cancer

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (7)

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

Queen Mary Hospital-Department of Obstetrics & Gynaecology

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital-Department of Oncology

Hong Kong, Hong Kong

RECRUITING

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong

RECRUITING

Tung Wah Hospital-Department of Surgery

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Wendy Wing Tak Lam, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Wing Tak Lam, PhD

CONTACT

+852 39179878; wwtlam@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, care provider, investigator and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or control arms. The participants are masked in terms of not knowing that one intervention is hypothesized to yield larger effects than the other.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 9, 2022
• Study Start: April 12, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (7)