NCT07553572

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress7%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

April 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 14, 2026

Last Update Submit

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

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Patients 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.

ASSIST phone application arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisLymphomaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Patrick C Johnson, MD

CONTACT

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

Locations