Remote Monitoring and Symptom Management Digital Application

Patrick C. Johnson, MD60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer (Locally Advanced or Metastatic)Lymphoma Colorectal Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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