Digital Symptom Tracking, Patient Engagement and Quality of Life in Advanced Cancer

NCT ID: NCT05112198

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2025-09-30

Brief Summary

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The purpose of this study is to (1) describe patient and clinician engagement in web-based symptom self-monitoring, (2) identify differences in symptom management between intervention and usual care groups, and (3) identify potential outcomes of real-time symptom tracking and management.

With the assistance of the study coordinator, participants randomized to the intervention will create an account with Noona. Patients will be instructed to log symptoms as often as relevant using their own personal devices. Patients will also be prompted once per week for 24 weeks to log any recent symptoms. These participants will be sent a Symptom Questionnaire (SQ) via the Noona tool that summarizes their symptoms and distress one week prior to each oncology clinic visit. Symptoms designated as clinically severe either during regular symptom logging or via the SQ will trigger a prompt to contact the clinical team for immediate follow-up.

Detailed Description

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New patients from three cancer care programs (thoracic oncology, gastrointestinal oncology, and palliative care) at two academic institutions (Stanford and UCSF) will be screened for demographic and disease stage data within the patient medical record. Eligible patients will be asked by their oncology team whether they would be interested in participating a study of symptom management in oncology care.

Patients who express interest and ability to participate will be interviewed to determine eligibility.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Noona web-based symptom tracking tool

In addition to usual care for their disease, patients interact with Noona system and system questioners to record their symptoms over a period of 6 months.

Group Type EXPERIMENTAL

Use of Noona web- based symptom tracking tool

Intervention Type DEVICE

Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress

Usual Care

Participants will receive the standard of care for their disease

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of Noona web- based symptom tracking tool

Noona patient reported outcome (PRO) platform tool that summarizes symptoms and distress

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Individuals (men and women) aged 18 years or older
2. Biopsy proven (recurrent or metastatic) advanced lung or gastrointestinal cancer
3. No limit on prior lines of therapy in the metastatic setting
4. ECOG performance status of 0-2
5. Estimated life expectancy of at least 6 months
6. Access to smartphone, tablet or computer with capability to utilize symptom tracking application
7. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
8. Willing and able to comply with all study procedures

Exclusion Criteria

1. Concurrent disease or condition that interferes with participation or safety
2. Non-english speaking, as the application is developed in the english language
3. Non-castrate resistant prostate cancer
4. Enrolled in other non-therapeutic or therapeutic clinical trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian Medical Systems

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kavitha Ramchandran, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Cancer Institute

Palo Alto, California, United States

Site Status

UCSF Helen Diller Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-12414

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-38423

Identifier Type: -

Identifier Source: org_study_id

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