RECRUITING

Comprehensive Outcomes for After Cancer Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.

Official Title

Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors

Quick Facts

Study Start:2022-06-23
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05349227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have primary diagnosis of cancer;
  2. 2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
  3. 1. For the purpose of this study, primary therapy is defined as treatment of curative intent, first-line or later, from which the individual is advancing to active surveillance or follow-up with or without maintenance therapy
  4. 2. For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic disease within the last year, are within one year of completion of initial therapy for their primary cancer diagnosis for which disease progression has occurred, or who are within one year of receiving treatment for metastatic disease (including individuals currently receiving treatment).
  5. 3. Are aged 18 years and older;
  6. 4. Can read and consent to participate in the trial;
  7. 5. Can read and speak English;
  8. 6. Can complete study follow-up at pre-specified intervals;
  9. 7. Have access to mobile technology (e.g. a smart phone or tablet) that would allow engagement in digital health coaching for the collection of PROs and wearable data.
  1. 1. Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program or complete study assessments;
  2. 2. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
  3. 3. Have a life expectancy of \<6 months, and/or
  4. 4. Are on active treatment for relapsed disease. a. Individuals with disease progression or relapse which occurs following their consent to participate will be given the option to continue on study if they wish to do so. Data from individuals experiencing disease progression or relapse will be grouped for sub-analysis to explore if and how relapse impacts study outcomes.
  5. 1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
  6. 2. Must reside in the same dwelling as the patient participant
  7. 3. Can read and consent to participate in the trial;
  8. 4. Can read and speak English;
  9. 5. Can complete study follow-up at pre-specified intervals;

Contacts and Locations

Study Contact

Kelly J Brassil, PhD
CONTACT
205-721-7542
dgxpharesearch@questdiagnostics.com
Jennifer Loftis, DNP
CONTACT
205-721-7542
dgxpharesearch@questdiagnostics.com

Principal Investigator

Marilyn Hammer, PhD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Alexi Wright, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Elizabeth Arthur, PhD
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center
Jessica Krok-Schoen, PhD
PRINCIPAL_INVESTIGATOR
The Ohio State University Wexner Medical Center
Robin Lally, PhD
PRINCIPAL_INVESTIGATOR
The University of Nebraska
Rachael Schmidt, DNP
PRINCIPAL_INVESTIGATOR
Nebraska Medicine
Debra E Lyon, PhD
PRINCIPAL_INVESTIGATOR
University of Florida College of Nursing
Anneliese Gonzalez, MD
PRINCIPAL_INVESTIGATOR
UTHealth Houston McGovern Medical School
Meagan Whisenant, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Kristen Fessele, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

The University of Florida
Gainesville, Florida, 32610
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
UT Health Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Pack Health

  • Marilyn Hammer, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute
  • Alexi Wright, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute
  • Elizabeth Arthur, PhD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center
  • Jessica Krok-Schoen, PhD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center
  • Robin Lally, PhD, PRINCIPAL_INVESTIGATOR, The University of Nebraska
  • Rachael Schmidt, DNP, PRINCIPAL_INVESTIGATOR, Nebraska Medicine
  • Debra E Lyon, PhD, PRINCIPAL_INVESTIGATOR, University of Florida College of Nursing
  • Anneliese Gonzalez, MD, PRINCIPAL_INVESTIGATOR, UTHealth Houston McGovern Medical School
  • Meagan Whisenant, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center
  • Kristen Fessele, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-23
Study Completion Date2027-05

Study Record Updates

Study Start Date2022-06-23
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Patient Reported Outcome Measures
  • Physical Activity
  • Digital Coaching
  • Microbiome
  • Wearables

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Breast Cancer
  • Lung Cancer
  • Gastric Cancer
  • Survivorship
  • Endometrial Cancer
  • Head and Neck Cancers
  • Prostate Cancers
  • Geriatric Oncology
  • Metastatic Breast Cancer
  • Metastatic Cancer