Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-11-11
2026-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer surviviors
Cancer Survivors who are on a scheduled therapeutic break or having completed cancer treatments,
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Bangor University
OTHER
Open University
OTHER
Laura Longshaw
OTHER_GOV
Responsible Party
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Laura Longshaw
Deputy Research and Development Manager
Locations
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Betsi Cadwaladr University Health board
Bangor, Gwynedd, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS 301068
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS301068
Identifier Type: -
Identifier Source: org_study_id
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