Evaluating the Implementation of a Need-Based Cancer Survivorship Program
ConditionCancer Survivorship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
The project aims to conduct an implementation evaluation of the need-based cancer survivorship program using the RE-AIM framework.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chinese/English speaking adult cancer patients aged 18 years or older
Within three years post-treatment attending the specialized outpatient clinics for surveillance
Disqualifiers
Non-Chinese or non-English speaking
Childhood cancer survivors
More than three years post-treatment
and/or unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Moderate needs intervention
BehavioralFor 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
BehavioralFor 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.
Treatment groups
12,500 Participants
are divided into 3 treatment groupsGroup A: Low needsNo intervention 0 interventions
Group B: Moderate needsActive comparator 1 intervention
Group C: High needsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to 36 months upon enrollment2
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.
Time frame
Assessed yearly during the 5-year study period3
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.
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.Secondary outcomes
1
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.
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.2
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.
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.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
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.
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.4
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
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.Sponsors and contacts
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Source ClinicalTrials.gov