Remote Monitoring and Symptom Management Digital Application (ASSIST)

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

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 Overview

• Status: Recruiting
• Conditions: Lymphoma; Colorectal Cancer; Breast Cancer (Locally Advanced or Metastatic)
• Intervention / Treatment: Other: ASSIST phone application

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick C Johnson, MD; Phone Number: 6177244000; Email: pcjohnson@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Patrick C Johnson, MD; Phone Number: 6177244000; Email: pcjohnson@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASSIST phone application arm; 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.	Other: ASSIST 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.
No Intervention: Usual Care; Patients in the usual care group will receive standard care from their oncology team, including routine symptom management and supportive care measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rates	We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients	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.	From enrollment to end of intervention at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of the intervention at 12 weeks

Collaborators and Investigators

• Sponsor: Patrick C. Johnson, MD

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Immune System Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Colorectal Neoplasms; Breast Neoplasms; Lymphoma; Neoplasm Metastasis
• Other Study ID Numbers: 25-739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No