Digital Health Coaching Program for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+4 More
Digital Health Coaching Program - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a digital health coaching intervention for people who have completed primary cancer therapy, to see if it's effective, acceptable, and feasible. 500 people with different types of cancer will be enrolled at up to 5 clinical sites.

Eligible Conditions
  • Breast Cancer
  • Ovarian Cancer
  • Malignant Neoplasm of Stomach
  • Lung Cancers
  • Survival Rate (Survivorship)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 11 Secondary · Reporting Duration: From date of enrollment to 12 months

Month 6
Acceptability of coaching intervention
Feasibility of coaching intervention
Month 12
Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a
Month 12
Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a
Change in Sleep-related Impairment as measured by the PROMIS Sleep related Impairment Short Form 8a
Month 12
Change in Depression as measured by the PROMIS Depression Short Form 8a
Month 12
Change in Economic Strain and Resilience in Cancer (ENRICh)
Change in The Comprehensive Score for Financial Toxicity (COST)
Month 12
Change in medication adherence for individuals taking maintenance therapies
Month 12
Change in the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 10a
Month 12
Change in Quality of Life as measured by The Functional Assessment of Cancer Therapy - General v4 (FACT-G)
Month 12
Change in Self-Efficacy for Managing Chronic Disease
Month 12
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Female
Month 12
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Male
Month 12
Change in symptom burden as measured by the Edmonton Symptom Assessment System-Revised (ESAS-R)
Month 12
Health Care Utilization
Month 6
Gut Microbiota
Month 12
Digital Engagement
Physical Activity
Month 6
Dietary Intake as measured by the 9.15 Automated Self-Administered 24 hour Dietary Assessment Tool (ASA24-2020)

Trial Safety

Trial Design

1 Treatment Group

Intervention Group
1 of 1

Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: Digital Health Coaching Program · No Placebo Group · N/A

Intervention GroupExperimental Group · 2 Interventions: Fitbit, Digital Health Coaching Program · Intervention Types: Device, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2018
N/A
~3440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date of enrollment to 12 months

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,013 Previous Clinical Trials
393,649 Total Patients Enrolled
134 Trials studying Breast Cancer
21,556 Patients Enrolled for Breast Cancer
University of NebraskaOTHER
479 Previous Clinical Trials
1,149,197 Total Patients Enrolled
13 Trials studying Breast Cancer
1,005,436 Patients Enrolled for Breast Cancer
GlaxoSmithKlineIndustry Sponsor
4,639 Previous Clinical Trials
7,944,399 Total Patients Enrolled
31 Trials studying Breast Cancer
2,325,653 Patients Enrolled for Breast Cancer
Daiichi Sankyo, Inc.Industry Sponsor
356 Previous Clinical Trials
341,054 Total Patients Enrolled
18 Trials studying Breast Cancer
14,578 Patients Enrolled for Breast Cancer
National Institute of Nursing Research (NINR)NIH
521 Previous Clinical Trials
285,583 Total Patients Enrolled
8 Trials studying Breast Cancer
1,482 Patients Enrolled for Breast Cancer
Pack HealthLead Sponsor
4 Previous Clinical Trials
504 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterOTHER
284 Previous Clinical Trials
285,459 Total Patients Enrolled
21 Trials studying Breast Cancer
2,350 Patients Enrolled for Breast Cancer
Rachael Schmidt, DNPPrincipal InvestigatorNebraska Medicine
Marilyn Hammer, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Elizabeth Arthur, PhDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
Jessica Krok-Schoen, PhDPrincipal InvestigatorThe Ohio State University Wexner Medical Center
Robin Lally, PhDPrincipal InvestigatorThe University of Nebraska
Alexi Wright, MDPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are aged 18 years and older.\n
You have access to a mobile device that would allow engagement in digital health coaching for the collection of PROs and wearable data.
You must agree to wear an activity tracking device.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References