Digital Monitoring in Cancer Survivors (NCT06669832) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital Monitoring in Cancer Survivors
United Kingdom50 participantsStarted 2024-11-11
Plain-language summary
Digital monitoring in cancer survivors WHY? There is a large amount of evidence to suggest that addressing a cancer patients' quality of life and symptoms has a positive impact on their wellbeing and experience with care. Finding ways of accurately and timely measuring Patient Reported Outcomes (PROs), along with developing electronic and mobile health (eHealth and mHealth) solutions, is being increasingly recognized as one way to manage patients' quality of life and symptoms without increasing burden on time and resource-stretched National Health Services.
WHAT? The main objective of this study is to assess the feasibility of administering routine self assessment through questionnaire called the Edmonton Symptom Assessment System (ESAS) via MS Forms associated with continuous wearing of a smart watch in cancer survivors. We also hope to identify predictors of attrition or dissatisfaction.
WHO? Adult outpatients with controlled cancer undergoing surveillance (cancer survivors) WHERE? Participants will be identified through attendance in oncology outpatient clinics by the oncologist in charge.
HOW? Participants will receive a smart watch and smart phone (or an App downloaded onto their own phone). The smart watch will record physical activity , sleep patterns and other data such as heart rate and participants are expected to wear the watch all the time for about 4 months. Participants will also attend the hospital for a research appointment at the start and the end of the research and complete questionnaires weekly throughout the study, delivered via MS forms. At the end of the study the patients will be invited to a focus group to discuss their experience. The study will last for 18 months; each participants' involvement will be for about 4 month.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Diagnosis of any solid malignancy, at any stage
* Completion of treatment (including surgery, radiotherapy, and any kind of cytotoxic systemic anticancer treatment \[hormonal and targeted treatments allowed\])
* Clinical, biochemical and radiological confirmation of controlled disease (no evidence of residual disease or not-progressive disease)
* Scheduled for either a therapeutic break (from cytotoxic systemic anticancer treatment), or having completed the planned multimodal treatment
* Scheduled for active surveillance plan within oncology service or discharged to surgical or GP care following completion of adjuvant treatment
* Male or female patients aged at least 18 years old
* WHO Performance Status 0-2
Exclusion Criteria:
* • Not in possession of a SIM card
* No internet access through Wi-Fi or unwilling to use mobile data allowance on a daily basis
* Unable to understand and follow the instructions autonomously
* Uncontrolled severe comorbidities (I.e., cardiovascular, neurological, respiratory)
* Lack of capacity
* Unable to understand English
* Still undergoing systemic anticancer treatment (apart from bone-targeted agents, hormonal treatment against breast or prostate cancers or maintenance monoclonal antibody monotherapy)
* Poor general condition (PS\>2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of routine self assessment
Timeframe: From enrolment until end of study at 16 weeks.