Comprehensive Outcomes for After Cancer Health

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Digital Health Coaching Program

Coaching consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

DEVICE

Fitbit

Device: Fitbit A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Sponsors & Collaborators

• Daiichi Sankyo

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• University of Nebraska

  collaborator OTHER

• Ohio State University Comprehensive Cancer Center

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Memorial Sloan Kettering Cancer Center

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Gilead Sciences

  collaborator INDUSTRY

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Pack Health

  lead INDUSTRY

Principal Investigators

• Marilyn Hammer, PhD · Dana-Farber Cancer Institute

• Alexi Wright, MD · Dana-Farber Cancer Institute

• Elizabeth Arthur, PhD · Ohio State University

• Jessica Krok-Schoen, PhD · Ohio State University

• Robin Lally, PhD · The University of Nebraska

• Rachael Schmidt, DNP · Nebraska Medicine

• Debra E Lyon, PhD · University of Florida College of Nursing

• Anneliese Gonzalez, MD · UTHealth Houston McGovern Medical School

• Kathrin Milbury, PhD · The University of Texas MD Anderson Cancer Center

• Kristen Fessele, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-23

Primary Completion

2026-12-31

Completion

2027-05-31

Countries

• United States

Study Locations