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NCT Number: NCT07553572

Remote Monitoring and Symptom Management Digital Application

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.

Recruiting

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Key information

Conditions

Breast Cancer (Locally Advanced or Metastatic) Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Patrick C Johnson, MD

CONTACT

[email protected]

6177244000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ASSIST phone application

Other

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.

Primary outcomes

  1. Recruitment Rates

    Time frame: From enrollment to end of intervention at 12 weeks

    We will deem the intervention feasible if recruitment rates achieve ≥ 60% of eligible patients

  2. Percentage of participants using the digital application once per week in at least 7/12 weeks

    Time frame: From enrollment to end of intervention at 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.

Secondary outcomes

  1. Acceptability

    Time frame: From enrollment to the end of the intervention at 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick C Johnson, MD

CONTACT

[email protected]

6177244000

Sponsors and collaborators

Lead sponsor

Patrick C. Johnson, MD

Other

Registry information

Official study title

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

Acronym: ASSIST

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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