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Remote Monitoring and Symptom Management Digital Application

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07553572
Acronym
ASSIST
Enrollment
60
Registered
2026-04-28
Start date
2026-04-14
Completion date
2027-03-31
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer (Locally Advanced or Metastatic), Colorectal Cancer, Lymphoma

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.

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.

Sponsors

Patrick C. Johnson, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment RatesFrom enrollment to end of intervention at 12 weeksWe will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients
Percentage of participants using the digital application once per week in at least 7/12 weeksFrom enrollment to end of intervention at 12 weeksThe 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.

Secondary

MeasureTime frameDescription
AcceptabilityFrom enrollment to the end of the intervention at 12 weeksThe 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.

Countries

United States

Contacts

CONTACTPatrick C Johnson, MD
pcjohnson@mgh.harvard.edu6177244000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026