Health TrialsbyHealthPanel

Remote Monitoring and Symptom Management Digital Application

ConditionsBreast Cancer (Locally Advanced or Metastatic)LymphomaColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPatrick C. Johnson, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Ability to understand English

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.

Expected treatment duration of at least 12 weeks

Disqualifiers

Cognitive impairment that would interfere with ability to use smartphone application (as assessed by their attending physician)

Visual or motor impairment that would prevent smartphone use

Expected survival less than 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • ASSIST phone application

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ASSIST phone application armExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

Acceptability

The intervention will be deemed acceptable if ≥ 80% of patients on the ASSIST intervention arm report satisfaction based on a rating of "Somewhat satisfied" or "Very satisfied" when asked about their experience with the intervention.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Patrick C. Johnson, MD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Source ClinicalTrials.gov
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