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
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
April 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
April 28, 2026
April 1, 2026
8 months
April 14, 2026
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Acceptability
From enrollment to the end of the intervention at 12 weeks
Study Arms (2)
ASSIST phone application arm
EXPERIMENTALThe 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.
Usual Care
NO INTERVENTIONPatients in the usual care group will receive standard care from their oncology team, including routine symptom management and supportive care measures.
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 Criteria
You may qualify if:
- 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
- Own or willing to receive a smartphone
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
April 14, 2026
First Posted
April 28, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share