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Pilot Randomized Controlled Trial of a Remote Monitoring and Symptom Management Intervention (ASSIST) Among Patients Receiving Systemic Therapy

NCT ID: NCT07553572Sponsor: Patrick C. Johnson, MDLast updated: 2026-04-28

Summary

The goal of this clinical trial is to learn if an artificial intelligence phone application called ASSIST can help patients receiving cancer treatment. The main question\[s\] it aims to answer are: Is ASSIST feasible for patients (meaning can it be used by patients)? Is ASSIST acceptable to patients (meaning do patients like it)? Researchers will compare the ASSIST phone application to see how it compares to usual clinical care. Participants on the ASSIST arm will use the ASSIST phone application for 12 weeks, and participants in both groups will complete surveys.

Arms & interventions

  • OtherASSIST phone application

    The intervention consists of a smartphone-based application that provides personalized support using AI during cancer treatment. Patients will also receive standard care from their oncology team, including routine symptom management and supportive care measures.

Outcome measures

Primary

  • Recruitment Rates

    We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients

    Time frame: From enrollment to end of intervention at 12 weeks

  • Percentage of participants using the digital application once per week in at least 7/12 weeks

    The intervention will be feasible if among those enrolled and randomized to the intervention arm, ≥ 60% use ASSIST once per week in at least 7/12 weeks.

    Time frame: From enrollment to end of intervention at 12 weeks

Secondary

  • Acceptability

    Time frame: From enrollment to the end of the intervention at 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Age 18 years or older 2. Ability to understand English 3. About to begin definitive systemic treatment (or within 4 weeks of beginning treatment) based upon the oncology treatment intent form for a new diagnosis of breast cancer, colorectal cancer, or lymphoma. 4. Expected treatment duration of at least 12 weeks 5. Own or willing to receive a smartphone Exclusion Criteria: 1. Cognitive impairment that would interfere with ability to use smartphone application (as assessed by their attending physician) 2. Visual or motor impairment that would prevent smartphone use 3. Expected survival less than 3 months

Study locations (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting
Patrick C Johnson, MD · Contact
Remote Monitoring and Symptom Management Digital Application | Cancerify