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NCT Number: NCT07830368

Evaluating the Implementation of a Need-Based Cancer Survivorship Program

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital-Department of Surgery, Hong Kong

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About this study

This study aims to implement the survivorship program through collaboration with NGOs and District Health Centers. The implementation of a need-based cancer survivorship program involves structured screening and needs assessment, with a focus on symptom distress and weight-related concerns. Based on identified needs, appropriate service referrals will be made to ensure timely and targeted support for cancer survivors.

The program is a prospective implementation study using both quantitative and qualitative methods, guided by the RE-AIM framework. The program plans to screen approximately 12,500 cancer survivors. The program will use the Edmonton Symptom Assessment System (ESAS) to identify symptom distress and a new diagnostic framework for weight-related concerns, with referrals made to JCICC or NGO/DHC partners for moderate-to-high needs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(Cancer patients)

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

Exclusion criteria

(Cancer patients)

  • Non-Chinese or non-English speaking
  • Childhood cancer survivors
  • More than three years post-treatment
  • and/or unable to provide informed consent

Inclusion criteria

(Peer volunteers)

  • Aged 18 years or older
  • Able to communicate in Chinese or English
  • Have lived experience as a cancer survivor or caregiver

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: From enrollment to 36 months upon enrollment

    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.

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

    Time frame: Assessed yearly during the 5-year study period

    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.

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

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

    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.

Secondary outcomes

  1. Symptom distress: The Edmonton Symptom Assessment System (ESAS)

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

    The Edmonton Symptom Assessment System (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. Weight control - Weight, Height, and Body Mass Index (BMI)

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

    The investigators will use the weight machine in the clinic to measure weight in kilograms and height in centimeters. Weight and height will be used to calculate BMI in kg/m². Based on Asia-Pacific cutoffs, individuals with a normal BMI (18.5-22.9) or overweight BMI (23.0-24.9) will be classified accordingly. Individuals with an obese BMI (>25.0) will be classified as having preclinical-to-clinical obesity.

  3. 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

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

    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.

    The generic EQ-5D-5L questionnaire evaluates five dimensions including mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale (1 = no problem; 2 = slight problem; 3 = moderate problem; 4 = severe problem; 5 = extreme problem). A continuous response scale ranging from 0 (worst possible health state) to 100 (best possible health state), to assess their self-rated health on the assessment day.

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

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

    The 6-item WPAI measures work productivity loss (the extent to which current health condition induced work inability) and activity impairment (the extent to which current health condition affected regular activities other than job-related work). Items assessing work productivity loss are only relevant to those who have returned to work. Both work productivity loss and activity impairment are expressed in percentages, with higher values indicative of greater productivity loss and impaired functioning

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

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

    Physical activity level will be assessed using the Global Physical Activity Questionnaire (GPAQ) developed by WHO. The GPAQ consists of 16 items designed to assess participants' physical activity level in work, transport and leisure time, and assess time spent in sedentary behaviours. Satisfactory convergent validly of the measure of moderate-to-vigorous physical activity was reported.

  6. Knowledge and awareness of symptom management and overall health condition: To assess patients' knowledge, skills, and confidence in managing their health

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

    The Patient Activation Measure (PAM-13) will be used to measure the patient's knowledge, skills and confidence. PAM-13 is a validated, non-disease-specific instrument applicable across diverse populations and healthcare settings, including cancer survivorship. It consists of 13 items rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), yielding a raw score between 13 and 52. This raw score is then transformed into a standardized activation score ranging from 0 to 100, with higher scores indicating greater patient activation.

    Self-efficacy will be assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS).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.

Study contacts

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

Danielle Ng

CONTACT

[email protected]

852 39179897

Wendy Lam

CONTACT

[email protected]

852 39179897

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Evaluating the Implementation of a Need-based Cancer Survivorship Program Using the REAIM Framework

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

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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