Digital Monitoring in Cancer Survivors

NCT ID: NCT06669832

Last Updated: 2025-09-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-11

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* • 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangor University

OTHER

Sponsor Role collaborator

Open University

OTHER

Sponsor Role collaborator

Laura Longshaw

OTHER_GOV

Sponsor Role lead

Responsible Party

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Laura Longshaw

Deputy Research and Development Manager

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Betsi Cadwaladr University Health board

Bangor, Gwynedd, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Laura Longshaw

Role: CONTACT

+443000856766

Pasquale Innominato

Role: CONTACT

+443000841563

Facility Contacts

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Laura Longshaw

Role: primary

+443000856766

Lona Tudor Jones

Role: backup

03000856766

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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