Cancer SurvivorshipNCT07830368
Evaluating the Implementation of a Need-Based Cancer Survivorship Program
A study testing Moderate needs intervention and High needs in people with Cancer Survivorship, run by The University of Hong Kong at 5 sites in Hong Kong.
Trial summary
The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Moderate needs intervention and High needs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,500 participants
- Where
- 5 sitesHong Kong
- Study dates
- 2 Mar 2026to 27 Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese/English speaking adult cancer patients aged 18 years or older
- Within three years post-treatment attending the specialized outpatient clinics for surveillance
- Aged 18 years or older
- Able to communicate in Chinese or English
- Have lived experience as a cancer survivor or caregiver
Who cannot join
- Non-Chinese or non-English speaking
- Childhood cancer survivors
- More than three years post-treatment
- and/or unable to provide informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Hong Kong5 sites, 5 recruiting
- Recruiting
Queen Mary Hospital-Department of Surgery
Hong Kong, Hong Kong, 000
Dominic Foo, ccfoo@hku.hk
- Recruiting
PYEH Department of Clinical Oncology
Hong Kong
Sung Inda Soong, +852 97194300, soongs@ha.org.hk
- Recruiting
Queen Mary Hospital-Department of Obstetrics & Gynaecology
Hong Kong
Karen Chan, kklchan@hku.hk
- Recruiting
Queen Mary Hospital-Department of Oncology
Hong Kong
Wendy Chan, winglok@hku.hk
- Recruiting
Queen Mary Hospital
Hong Kong
Wendy Lam, 85239179878, wwtlam@hku.hk
About this study
Official title: Evaluating the Implementation of a Need-based Cancer Survivorship Program Using the REAIM Framework
The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.
Read the detailed description
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.
- Conditions
- Cancer Survivorship
- Being tested
- Moderate needs intervention, High needs
- Keywords
- Cancer survivorship, Community-based cancer survivorship care model, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate needs interventionBehavioural
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 needsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: High needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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
Measured: 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)
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.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.
Knowledge and awareness of symptom management and overall health condition: To assess patients' knowledge, skills, and confidence in managing their health
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.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months post-initial assessment, and subsequently every 6 months throughout the 5-year study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start2 Mar 2026
- Primary completion27 Feb 2031 (estimated)
- Study completion27 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830368
- Sponsor's protocol ID
- UW 26-031 JCImp
- Status last verified
- Feb 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the PI upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation of a Need-based Cancer Survivorship Program Using the REAIM Framework
- ClinicalTrials.gov ID
- NCT07830368
- Acronym / sponsor ID
- UW 26-031 JCImp
- Conditions
- Cancer Survivorship
- Keywords
- Cancer survivorship, Community-based cancer survivorship care model, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 27 Feb 2031 (estimated)
- Study completion
- 27 Feb 2032 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Moderate needs interventionPatients 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. |
| High needs | Active comparator | Behavioral: High needsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese/English speaking adult cancer patients aged 18 years or older
- Within three years post-treatment attending the specialized outpatient clinics for surveillance
- Aged 18 years or older
- Able to communicate in Chinese or English
- Have lived experience as a cancer survivor or caregiver
Key exclusion criteria (4 listed)
- Non-Chinese or non-English speaking
- Childhood cancer survivors
- More than three years post-treatment
- and/or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate needs interventionFor 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. | Behavioural | Moderate needs |
| High needsFor 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. | Behavioural | High needs |
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the PI upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate needs intervention and High needs in people with Cancer Survivorship, run by The University of Hong Kong at 5 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendy Lam (852 39179897, wwtlam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach: The percentage of eligible patients being assessed, advised, and referred based on need. (time frame: From enrollment to 36 months upon enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.