- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06669832
Digital Monitoring in Cancer Survivors (DM-CS)
Digital Monitoring in Cancer Survivors: a Feasibility Pilot Combining a Smartwatch and Patient-reported Outcome Measures
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laura Longshaw
- Phone Number: +443000856766
- Email: Laura.Longshaw@wales.nhs.uk
Study Contact Backup
- Name: Pasquale Innominato
- Phone Number: +443000841563
- Email: Pasquale.Innominato@wales.nhs.uk
Study Locations
-
-
Gwynedd
-
Bangor, Gwynedd, United Kingdom, LL57 2PW
- Recruiting
- Betsi Cadwaladr University Health Board
-
Principal Investigator:
- Pasquale Innominato
-
Contact:
- Laura Longshaw
- Phone Number: +443000856766
- Email: Laura.Longshaw@wales.nhs.uk
-
Contact:
- Lona Tudor Jones
- Phone Number: 03000856766
- Email: BCU.researchapplications@wales.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Cancer surviviors
Cancer Survivors who are on a scheduled therapeutic break or having completed cancer treatments,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of routine self assessment
Time Frame: From enrolment until end of study at 16 weeks.
|
To assess the feasibility of routine self-assessment through questionnaire (ESAS) on an App associated with continuous wearing of a smart watch in cancer survivors.
|
From enrolment until end of study at 16 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS301068
- IRAS 301068 (Other Identifier: Betsi Cadwaladr University Health Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Second Affiliated Hospital of Soochow UniversityNot yet recruitingCancer | Solid Cancer
-
New Mexico Cancer Research AllianceOhio State University Comprehensive Cancer Center; H. Lee Moffitt Cancer Center...RecruitingCancer | Cancer RiskUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States