Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process

NCT06274892 | Recruiting

• 1 other identifier: 23-5818
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making. Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life. Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT. Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life.

Conditions

Prostate Cancer; Breast Cancer

Keywords

Radiation Therapy; Patient reported outcomes; Remote monitoring; Mobile phone application

Outcome Measures

Primary Outcomes (1)

• Remote monitoring efficiency

  Proportion of review visits attended during RT, and up to 12 weeks after RT. Number of review visits attended (from weekly participant questionnaire) as a percentage of the total possible review visits. Values will range from 0% to 100%. Low percentage indicates desirable outcome.

  At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

Secondary Outcomes (7)

• Remote monitoring efficacy

  At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

• Remote monitoring value

  At the end of radiation (average 5 weeks)

• Remote monitoring comprehensiveness

  At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

• Influencing factors (patient)

  At the end of radiation (average 5 weeks)

• Influencing factors (disease)

  At the end of radiation (average 5 weeks)

Study Arms (2)

Remote monitoring PROs

EXPERIMENTAL

All participants allocated to the interventional arm will receive the RT technique, dose and fractionation according to institutional standards. Once per week, participants will use a mobile phone 'app' to enter mPROs, and indicate a need for review for any other reason. The treatment Radiation Therapists will triage the participant to either attend or skip that week's on-treatment review based on this information and established criteria. After RT completion, Advanced Practice Radiation Therapists (apRTs) will triage the participant to receive a virtual follow-up visit when necessary. Participants will be seen once by a Radiation Oncologist 4 to 12 weeks after last radiation treatment. The participants will also complete the following questionnaires: 1) Baseline (patient factors); 2) 'During treatment' (review quality); 3) 'Post acute phase' (satisfaction with care). Circle-of-care HCP will comment on the impact of the PROMOTE process on the quality of care for that participant.

Other: Remote monitoring PROs

Standard of Care

NO INTERVENTION

All participants allocated to the standard of care arm will receive all RT treatment activities according to institutional standards. Participants will attend the weekly in-person review session with a Radiation Oncologist during treatment and will be seen once between 4 and 12 weeks after last RT treatment. Documentation of radiation-related toxicity will be performed by the radiation HCPs according to standard of care. Participants will be asked to complete the following study questionnaires: 1) Baseline evaluation (patient factors); 2) 'During treatment' evaluation (need/usefulness of review); 3) 'Post acute phase' evaluation (satisfaction with care).

Interventions

Remote monitoring PROs OTHER

Attendance at RT review appointments triaged based on remotely monitored PROs

Also known as: Zamplo mobile healthcare application

Remote monitoring PROs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of breast or prostate cancer
• About to receive a course of radical or adjuvant radiation therapy as an outpatient at Princess Margaret Cancer Centre
• Able to enter PRO responses into the mobile app in English or French

You may not qualify if:

• Significant comorbidities that would render the patient not suitable for remote monitoring

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2J9, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Tara Rosewall, PhD

CONTACT

416 946 2000; tara.rosewall@rmp.uhn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: February 23, 2024
• Study Start: April 9, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)