Physical Symptom DistressNCT05534386
A Self-management Based Survivorship Intervention for Chinese Cancer Survivors
A study testing Cancer survivorship care intervention and Step-up targeted personalized intervention in people with Physical Symptom Distress and Weight Management, run by The University of Hong Kong at 7 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Symptom Distress, Weight Management, Neoplasms
- What is being tested?
- Cancer survivorship care intervention and Step-up targeted personalized intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 7 sitesHong Kong
- Study dates
- 12 Apr 2023to 31 Dec 2027
- 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
- Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
- have completed primary and adjuvant treatment within the past six months
Who cannot join
- Patients diagnosed with metastatic cancer
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Hong Kong7 sites, 3 recruiting
- Active, not recruiting
Kwong Wah Hospital-Breast Center
Hong Kong
- Active, not recruiting
Pamela Youde Nethersole Eastern Hospital-Department of oncology
Hong Kong
- Active, not recruiting
Prince of Wales Hospital-Department of Surgery
Hong Kong
- 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-Department of Surgery
Hong Kong
Dominic Foo, ccfoo@hku.hk
- Active, not recruiting
Tung Wah Hospital-Department of Surgery
Hong Kong
About this study
Official title: How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors
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.
Read the detailed description
This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.
- Conditions
- Physical Symptom Distress, Weight Management, Neoplasms
- Being tested
- Cancer survivorship care intervention, Step-up targeted personalized intervention, First stage control intervention, Second stage control intervention
- 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer survivorship care interventionBehavioural
A one-off face-to-face assessment and personal advice by members of a multidisciplinary team
Step-up targeted personalized interventionBehavioural
To provide a more personalized intervention to the participants, but focusing more on symptom management and weight control.
First stage control interventionBehavioural
A set of skill-based pamphlets will be given.
Second stage control interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Behavioral: Second stage control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-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.
Measured: 12-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.
Measured: Baseline and 12-months post-baseline
Secondary outcomes (6)
Change in total scores of self-efficacy
The process outcome is change in total scores of self-efficacy assessed by Self-Efficacy for Managing Chronic Disease scale (SEMCDS) from baseline to 4-months post-baseline, and baseline to 12 months post-baseline. 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, 4-months post-baseline, and 12 months post-baseline
Fear of cancer recurrence
The 42-items Fear of cancer recurrence inventory comprised of seven subscales will be used to assess the change of fear of cancer recurrence (FCR). Each item is rated on a 5-point Likert Scale with a total score ranging from 0 to 168. Higher scores indicate greater FCR. The subscale, Severity will be used as a screening tool for high level of FCR. A score of 13 or higher was optimal for screening.
Measured: Baseline, 4-months post-baseline, and 12 months post-baseline
Illness perception
Cognitive and emotional representations of illness were measured using the nine-item Brief Illness Perception Questionnaire (B-IPQ).
Measured: Baseline, 4-months post-baseline, and 12 months post-baseline
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.
Measured: 12-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.
Measured: 12-months post-baseline
Health state
Health questionnaire (EQ-5D-5L) including five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression will be used to assessed participants' health state. Each dimension has 5 levels from no problems, slight problems, moderate problems, severe problems to extreme problems. The EQ-5D-5L also records participants self-rated health on a vertical visual analogue scale, where higher values indicate better health the participants can imagine.
Measured: Baseline, 4-months post-baseline, and 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start12 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Symptom DistressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Wing Tak Lam, The University of Hong Kong
- Investigators
- Wendy Wing Tak Lam, PhD, Principal investigator, School of Public Health, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534386
- Sponsor's protocol ID
- UW20-100
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2022
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Prevent Lost in Transition? - Adaptive Randomised Controlled Trial of a Self-management Based Survivorship Intervention for Chinese Cancer Survivors
- ClinicalTrials.gov ID
- NCT05534386
- Acronym / sponsor ID
- UW20-100
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2022 (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.
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.
Detailed description
This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| First stage intervention: Cancer survivorship care intervention (CSCI) | Experimental | Behavioral: Cancer survivorship care interventionPatients 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. |
| First stage intervention: Control intervention | Active comparator | Behavioral: First stage control interventionPatients 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. |
| Second stage intervention: Step-up targeted personalized intervention | Experimental | Behavioral: Step-up targeted personalized interventionThe 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. |
| Second stage intervention: Control intervention | Active comparator | Behavioral: Second stage control interventionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
- have completed primary and adjuvant treatment within the past six months
Key exclusion criteria (1 listed)
- Patients diagnosed with metastatic cancer
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 |
|---|---|---|
| Cancer survivorship care interventionA one-off face-to-face assessment and personal advice by members of a multidisciplinary team | Behavioural | First stage intervention: Cancer survivorship care intervention (CSCI) |
| Step-up targeted personalized interventionTo provide a more personalized intervention to the participants, but focusing more on symptom management and weight control. | Behavioural | Second stage intervention: Step-up targeted personalized intervention |
| First stage control interventionA set of skill-based pamphlets will be given. | Behavioural | First stage intervention: Control intervention |
| Second stage control interventionThose 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 | Behavioural | Second stage intervention: Control intervention |
Primary outcome
Proportion of symptom distress caseness (distress prevalence)
Time frame: 12-months post-baseline
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.
Proportion of patients with suboptimal weight control
Time frame: 12-months post-baseline
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.
Change in total score of health-related quality of life
Time frame: Baseline and 12-months post-baseline
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.
6 secondary outcomes
Change in total scores of self-efficacy
Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline
Fear of cancer recurrence
Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline
Illness perception
Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline
Proportion of symptom distress caseness (distress prevalence)
Time frame: 12-months post-baseline
Proportion of patients with suboptimal weight control
Time frame: 12-months post-baseline
Health state
Time frame: Baseline, 4-months post-baseline, and 12 months post-baseline
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 13 Aug 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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Caregiver, Health Care Provider
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.
Wendy Wing Tak Lam, PhD principal investigator
School of Public Health, The University of Hong Kong
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer survivorship care intervention and Step-up targeted personalized intervention in people with Physical Symptom Distress and Weight Management, run by The University of Hong Kong at 7 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 2 inclusion and 1 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Wing Tak Lam, PhD (+852 39179878, wwtlam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of symptom distress caseness (distress prevalence) (time frame: 12-months post-baseline). 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 13 Aug 2026.