Recruiting

Observational Study

Sponsor:

Pack Health

Code:

NCT05349227

Conditions

Ovarian Cancer

Breast Cancer

Lung Cancer

Gastric Cancer

Survivorship

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Digital Health Coaching Program

Fitbit

Study Details

Brief 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

Study ID

NCT05349227

Start date

Jun 23, 2022

Status verified date

Sep, 2024

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

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
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).
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.

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;

Study Design

Enrollment

625 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Acceptability of coaching intervention [ Time Frame: At 6 months following the start of the coaching intervention ]
  • Feasibility of coaching intervention [ Time Frame: At 6 months following the start of the coaching intervention ]
  • Change in Self-Efficacy for Managing Chronic Disease [ Time Frame: Change in baseline perception of self-efficacy at 12 months ]

Central Contacts and Locations

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Pack Health

Last update posted

Dec 11, 2024

Last verified

Sep, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pack Health on 2024-12-11.