Comprehensive Outcomes for After Cancer Health

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Pack Health
Study ID
NCT05349227
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Digital Health Coaching Program — BEHAVIORAL
    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.
  • Fitbit — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 23, 2022
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
625 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Group
    In addition to standard of care services at the participant's respective health system, and study specific collection of clinical, PRO, and wearable data, as well as microbiome specimens, individuals randomized to the intervention group will receive immediate enrollment to a 6-month digital health coaching program followed by 6 months monitoring via PRO, wearable, and clinical data collection. They will collect fecal microbiome samples at baseline (study enrollment) and month 6 following enrollment.
  • Other: Wait List Control Group
    In addition to standard of care services, individuals in the wait list control will be monitored via the collection of PRO, clinical, and wearable data for the first 6 months, along with fecal microbiome collection at study enrollment baseline (study enrollment) and month 6. At month 6 these individuals will be enrolled into the 6-month digital health coaching program, during which clinical, PRO and wearable data will continue to be collected. At the completion of the 6-month coaching these individuals will come off study and will not receive additional follow-up.
  • No Intervention: Household Healthy Participants
    A cohort of consisting of adults without a cancer diagnosis residing in the same residence as participants, will be consented to collect fecal microbiome specimens to serve as a control for potential regional variation in microbiome dysbiosis. Up to 25 healthy controls will be enrolled per 100 participants at each study site. At sites enrolling fewer than 100 participants, an n up to 25% of the total patient enrollment sample will be approached for enrollment.

Primary Outcome Measure

Acceptability of coaching intervention [ Time Frame: At 6 months following the start of the coaching intervention ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The University of FloridaGainesvilleFlorida32610-
Dana Farber Cancer InstituteBostonMassachusetts02215
Marilyn Hammer, PhD
[email protected]
347-271-0293
Alexi Wright, MD, MPH
[email protected]
617-632-2334
Marilyn Hammer, PhD
Alexi Wright, MD, MPH
University of Nebraska Medical CenterOmahaNebraska68106-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Kristen L Fessele, PhD
[email protected]
646-449-1076
Kristen L Fessele, PhD
The Ohio State University Wexner Medical CenterColumbusOhio43210-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Kathrin Milbury, PhD
[email protected]
713-745-2868
Meagan Whisenant, PhD
[email protected]
713-500-2279
Meagan Whisenant, PhD
Debu Tripathy, MD
Abbey Kaler, MSN
UT Health HoustonHoustonTexas77030
Kaukab I Jafry, MD, MBBS
[email protected]
832 325 6537
Martha Thompson
[email protected]
832-325-7706
Anneliese Gonzalez, MD

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The University of Florida· Gainesville, FLDana Farber Cancer Institute· Boston, MAUniversity of Nebraska Medical Center· Omaha, NEMemorial Sloan Kettering Cancer Center· New York, NYThe Ohio State University Wexner Medical Center· Columbus, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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