Remote Monitoring for Breast and Prostate Cancer (PROMOTE Trial)

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the treatment process for breast and prostate cancer patients undergoing radiation therapy (RT). Patients often experience side effects from RT, and by allowing them to self-report these side effects using mobile

Who is the study for?

This trial is for outpatients at Princess Margaret Cancer Centre about to undergo radical or adjuvant radiation therapy for breast or prostate cancer. Participants must be able to use a mobile app in English or French to self-report their health outcomes.

What is being tested?

The study tests if using mobile apps for patients to report side effects (mPROs) and remote monitoring by healthcare providers can improve the timing and quality of patient care during and after radiation therapy.

What are the potential side effects?

While this trial focuses on monitoring rather than medication, potential side effects being reported could include skin reactions, fatigue, digestive issues, urinary problems related to radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of radiation (average 5 weeks), and 12 weeks after completion of radiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Remote monitoring efficiency

Secondary study objectives

Influencing factors (disease)

Influencing factors (patient)

Influencing factors (toxicity)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Remote monitoring PROsExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 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).

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