Evaluating the Implementation of a Need-Based Cancer Survivorship Program

NCT07830368 | Recruiting

• 1 other identifier: UW 26-031 JCImp
• Study Type: interventional
• Target: 12,500
• Locations: 1 country
• Sites: 5

Brief Summary

The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.

Conditions

Cancer Survivorship

Keywords

Cancer survivorship; Community-based cancer survivorship care model; Cancer

Outcome Measures

Primary Outcomes (3)

• Reach: The percentage of eligible patients being assessed, advised, and referred based on need.

  Reach will be assessed as the percentage of eligible patients being assessed, advised, and referred based on need. Clinical units will submit weekly records of eligible patients assessed, advised, and referred to JCICC/NGO/DHC partners. The investigators will measure referral uptake through the proportion of patients accepting moderate- and high-need programs, examining attendance patterns and attrition rates. Weekly records will be collected from JCICC and NGO/DHC partners.

  From enrollment to 36 months upon enrollment

• Adoption: The proportion of intervention agents willing to initiate the program,

  Adoption refers to the proportion of intervention agents willing to initiate the program, including patient volunteers, HCPs from clinical units, and NGO partner staff. For patient volunteers, the investigators assessed enrollment and training completion rates, requiring minimum 50% enrollment by potential active members. For HCPs and NGO/DHC staff, the investigators will calculate participation rates. The acceptability, appropriateness, and feasibility will be measured using the four-item Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). Each item is rated on a 5-point Likert scale ranging from 1 to 5 to measure the agreeability, with higher scores indicating greater acceptability, appropriateness, and feasibility.

  Assessed yearly during the 5-year study period

• Effectiveness: Need-based cancer survivorship program will be assessed on patients' outcomes

  Effectiveness of need-based cancer survivorship program will be assessed on patients' outcomes including symptom distress, weight control, health-related quality of life, work productivity and activity impairment, lifestyle changes (such as physical activity levels, diet quality, alcohol consumption, and smoking habits), knowledge and awareness of symptom management and overall health condition, satisfaction with services received, and health care utilization.

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

Secondary Outcomes (6)

• Symptom distress: The Edmonton Symptom Assessment System (ESAS)

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

• Weight control - Weight, Height, and Body Mass Index (BMI)

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

• Health-related quality of life: The Standard Chinese version of the European Organization Research Treatment Cancer (EORTC) general quality of life questionnaire (QLQ-C30) and generic EQ-5D-5L questionnaire

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

• Work productivity and activity impairment: The Chinese version of the Work Productivity and Activity Impairment (WPAI) questionnaire

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

• Lifestyle changes (e.g. physical activity levels, diet quality, alcohol consumption, and smoking habits)

  Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.

Study Arms (3)

Low needs

NO INTERVENTION

Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is less than 4 and the BMI falls within the normal range (18.5-22.9), the patient will be categorized as Low needs. No referral will be made to NGO/DHCs; instead, the patient will receive two leaflets-one on diet and one on emotional well-being.

Moderate needs

ACTIVE COMPARATOR

Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is between 4 and 6 (inclusive) and the BMI indicates overweight status (23-24.9), the patient will be categorized as Moderate needs.

Behavioral: Moderate needs intervention

High needs

ACTIVE COMPARATOR

Patients will complete the ESAS and have their weight and height measured to calculate BMI. If the ESAS score is equal to or greater than 7 and the BMI indicates obesity (25 or higher), the patient will be categorized as High needs.

Behavioral: High needs

Interventions

Moderate needs intervention BEHAVIORAL

For patients with Moderate needs, e-interventions will be provided to help manage selected distress symptoms and weight issues. E-intervention videos will be sent to patients weekly or bi-weekly. These videos will address specific symptoms, including their causes and skills for management, to promote self-management and self-help. Peer volunteers or research assistants will accompany patients throughout the process, conducting follow-ups, offering support, and encouraging them to practice the skills.

Moderate needs

High needs BEHAVIORAL

For patients with High needs, referrals will be made to NGOs for further support to manage the selected distress symptoms and weight issues, provided the patient agrees to the referral. NGO nursing staff will contact the patient for a detailed consultation and determine the appropriate services to help reduce symptom distress and address weight concerns. NGOs will follow the pre-defined clinical pathway and follow-up procedures for referred patients.

High needs

Eligibility Criteria

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

You may qualify if:

• Chinese/English speaking adult cancer patients aged 18 years or older
• Within three years post-treatment attending the specialized outpatient clinics for surveillance

You may not qualify if:

• Non-Chinese or non-English speaking
• Childhood cancer survivors
• More than three years post-treatment
• and/or unable to provide informed consent
• Aged 18 years or older
• Able to communicate in Chinese or English
• Have lived experience as a cancer survivor or caregiver

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (5)

Queen Mary Hospital-Department of Surgery

Hong Kong, Hong Kong, 000, Hong Kong

RECRUITING

PYEH Department of Clinical Oncology

Hong Kong, Hong Kong

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

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Wendy Lam

CONTACT

852 39179897; wwtlam@hku.hk

Danielle Ng

CONTACT

852 39179897; dwlng@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 21, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): February 27, 2031
• Study Completion (Estimated): February 27, 2032
• Last Updated: September 21, 2026

Record last verified: 2026-02

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 (5)