Comprehensive Outcomes for After Cancer Health
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 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 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
🗓️ Study Start (Actual) 23 June 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 660
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Gainesville, Florida, United States
📍 Boston, Massachusetts, United States
📍 Omaha, Nebraska, United States
📍 New York, New York, United States
📍 Columbus, Ohio, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Have primary diagnosis of cancer;
    • 2. Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
    • a. 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
    • 3. Are aged 18 years and older;
    • 4. Can read and consent to participate in the trial;
    • 5. Can read and speak English;
    • 6. Can complete study follow-up at pre-specified intervals;
    • 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.
    • 8. Agree to wear and have data collected from an activity tracking device

    Exclusion Criteria:

    • 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. Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
    • 3. Have a life expectancy of \<6 months, and/or
    • 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.
    • Healthy Volunteers must:
    • 1. Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
    • 2. Must reside in the same dwelling as the patient participant
    • 3. Can read and consent to participate in the trial;
    • 4. Can read and speak English;
    • 5. Can complete study follow-up at pre-specified intervals;
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 14 April 2022
  • First Submitted that Met QC Criteria 21 April 2022
  • First Posted 27 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 May 2024
  • Last Update Posted 30 May 2024
  • Last Verified May 2024