Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
625 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-23
Study Completion Date
2027-05-31
Brief Summary
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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.
Detailed Description
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Background: There are an estimated 16.9 million cancer survivors in the United States, accounting for approximately 5% of the entire US population, and this number is anticipated to increase by 31% over the next 10 years to include 22.2 million individuals.1 Due to advances in therapy individuals with cancer are experiencing increased overall survival that is often accompanied by the management of cancer as a chronic condition.2 As such many individuals require maintenance therapies that extend for months or years beyond the completion of primary therapy with surgery, radiation, and/or pharmacologic therapies. Chronic management of cancer care may include both long-term maintenance therapy as well as the management of treatment-related sequelae, the majority of which occurs beyond the clinical setting. Supportive care needs include symptom support, general wellness, and a focus on the importance of adherence to treatment and follow-up, all of which may influence quality and quantity of life. Accordingly, there is a critical and growing need for comprehensive, accessible platforms to support survivor self-management of symptoms and general wellness (including physical, functional, and psychosocial well-being and healthcare adherence). There is furthermore a critical knowledge gap on the correlation between individual symptoms and wellness on novel biomarkers, specifically intestinal (gut) microbiome. Gut microbiome regulates critical physiological processes-digestion, mood, and overall immune health, but to date studies have focused on dysbiosis during cancer treatment. The investigators seek to explore dynamics of gut microbiota after cancer treatment and understand how health behavioral changes prompted by health coaching to modulate symptoms and physical/ psychosocial well-being may also positively influence the restoration of gut flora.
Aims: The objective of this randomized, wait-list control study is to assess the effect of a 6-month digital health coaching program in cancer survivors within 1 year of primary treatment and longitudinally measure its impact on multifaceted health outcomes. The investigators aim to: 1) Primarily, assess the feasibility, acceptability, and effect of digital health coaching on participants' health self-efficacy; 2) Secondarily, characterize associations between participant symptoms, physical/psychosocial well-being, and health self-management and gut microbiota changes; and 3) Explore patient-generated health data outcomes among participants (patient-reported \[PROs\] and wearable biometrics outcomes).
Methods: The proposed study will utilize a randomized-wait list control design to enroll up to 625 individuals with diverse tumor types who have completed primary treatment and are within 1 year of diagnosis. Each of up to 8 collaborating sites will enroll up to 100 participants. Participants will be enrolled in a 6-month digital health coaching program that combines person-to-person calls once weekly, accompanied by up to 4 digital nudges of evidence-based content via text, email and/or mobile application, based on the participant's preference. Content will focus on key topics designed to optimize survivorship outcomes, including management of late and long-term effects of therapy, diet and exercise, fatigue, financial toxicity, and other associated symptoms (e.g., sleep disturbance, depression), medication adherence, surveillance, and managing anxiety and fear of cancer recurrence. The program emphasizes targeting modifiable behaviors that can improve quality of life and health outcomes, including progression-free and overall survival. Those randomized to the intervention group will receive the 6-month coaching intervention up front followed by 6 months of on-going clinical, patient reported, activity, and microbiome data collection. Those randomized to the control will receive 6-months of clinical, patient reported, activity, and microbiome data collection, after which they will be randomized to the digital health coaching intervention.
Outcome Measures: All participants will be followed for 12-months during which time they will be provided with Fitbit devices to track engagement in physical activity. Microbiome samples will be collected at enrollment and 6 months to explore biomarkers of inflammation, which will be analyzed to examine associations between microbiota signatures and engagement in physical activity and PROs. Genomic bacterial DNA will be extracted and analyzed for any taxonomic changes in the microbiota diversity and composition with 16s rRNA sequencing. Microbiome analysis will be conducted in partnership with The National Institute of Nursing Research (NINR). PROs will be collected at baseline and months 3, 6, 9, and 12 to track progress during and following the program and to provide insights into the experience of quality of life, symptom burden, mental health, cognitive function, sleep quality, sexual health, and financial toxicity.
Rationale: This program seeks to address survivors' total well-being, including co-morbid conditions, psychosocial wellness, and healthy lifestyle behaviors, to enhance outcomes for individuals who have completed primary therapy for a cancer diagnosis. The approach is innovative in exploring how digital health coaching may be used to support the holistic needs of cancer survivors beyond the clinical care setting. The robust collection of patient-reported, wearable, biomarker, and clinical data, as well as qualitative data related to patient priorities, concerns and challenges in the context of Health Coaching, will allow for triangulation of data to comprehensively inform the experience of individuals following primary therapy as they manage their health in the community setting.
Aims: The objective of this randomized, wait-list control study is to assess the effect of a 6-month digital health coaching program in cancer survivors within 1 year of primary treatment and longitudinally measure its impact on multifaceted health outcomes. The investigators aim to: 1) Primarily, assess the feasibility, acceptability, and effect of digital health coaching on participants' health self-efficacy; 2) Secondarily, characterize associations between participant symptoms, physical/psychosocial well-being, and health self-management and gut microbiota changes; and 3) Explore patient-generated health data outcomes among participants (patient-reported \[PROs\] and wearable biometrics outcomes).
Methods: The proposed study will utilize a randomized-wait list control design to enroll up to 625 individuals with diverse tumor types who have completed primary treatment and are within 1 year of diagnosis. Each of up to 8 collaborating sites will enroll up to 100 participants. Participants will be enrolled in a 6-month digital health coaching program that combines person-to-person calls once weekly, accompanied by up to 4 digital nudges of evidence-based content via text, email and/or mobile application, based on the participant's preference. Content will focus on key topics designed to optimize survivorship outcomes, including management of late and long-term effects of therapy, diet and exercise, fatigue, financial toxicity, and other associated symptoms (e.g., sleep disturbance, depression), medication adherence, surveillance, and managing anxiety and fear of cancer recurrence. The program emphasizes targeting modifiable behaviors that can improve quality of life and health outcomes, including progression-free and overall survival. Those randomized to the intervention group will receive the 6-month coaching intervention up front followed by 6 months of on-going clinical, patient reported, activity, and microbiome data collection. Those randomized to the control will receive 6-months of clinical, patient reported, activity, and microbiome data collection, after which they will be randomized to the digital health coaching intervention.
Outcome Measures: All participants will be followed for 12-months during which time they will be provided with Fitbit devices to track engagement in physical activity. Microbiome samples will be collected at enrollment and 6 months to explore biomarkers of inflammation, which will be analyzed to examine associations between microbiota signatures and engagement in physical activity and PROs. Genomic bacterial DNA will be extracted and analyzed for any taxonomic changes in the microbiota diversity and composition with 16s rRNA sequencing. Microbiome analysis will be conducted in partnership with The National Institute of Nursing Research (NINR). PROs will be collected at baseline and months 3, 6, 9, and 12 to track progress during and following the program and to provide insights into the experience of quality of life, symptom burden, mental health, cognitive function, sleep quality, sexual health, and financial toxicity.
Rationale: This program seeks to address survivors' total well-being, including co-morbid conditions, psychosocial wellness, and healthy lifestyle behaviors, to enhance outcomes for individuals who have completed primary therapy for a cancer diagnosis. The approach is innovative in exploring how digital health coaching may be used to support the holistic needs of cancer survivors beyond the clinical care setting. The robust collection of patient-reported, wearable, biomarker, and clinical data, as well as qualitative data related to patient priorities, concerns and challenges in the context of Health Coaching, will allow for triangulation of data to comprehensively inform the experience of individuals following primary therapy as they manage their health in the community setting.
Conditions
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Ovarian Cancer
Breast Cancer
Lung Cancer
Gastric Cancer
Survivorship
Endometrial Cancer
Head and Neck Cancers
Prostate Cancers
Geriatric Oncology
Metastatic Breast Cancer
Metastatic Cancer
Keywords
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Patient Reported Outcome Measures
Physical Activity
Digital Coaching
Microbiome
Wearables
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Wait list control trial in which up to 625 patients will be randomized to receive either 6-months of digital coaching immediately followed by 6-months of monitoring or 6-months of monitoring followed by 6-months of digital health coaching. All participants will receive 12 months of patient reported outcomes collection and activity tracking via wrist-worn devices, as well as microbiome collection at baseline and month 6 only.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Digital Health Coaching Program
Intervention Type
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
Intervention Type
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.
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.
Group Type
OTHER
Digital Health Coaching Program
Intervention Type
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
Intervention Type
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.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
BEHAVIORAL
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.
Intervention Type
DEVICE
Eligibility Criteria
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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.
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;
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;
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Daiichi Sankyo
INDUSTRY
Sponsor Role
collaborator
GlaxoSmithKline
INDUSTRY
Sponsor Role
collaborator
University of Nebraska
OTHER
Sponsor Role
collaborator
Ohio State University Comprehensive Cancer Center
OTHER
Sponsor Role
collaborator
The University of Texas Health Science Center, Houston
OTHER
Sponsor Role
collaborator
M.D. Anderson Cancer Center
OTHER
Sponsor Role
collaborator
University of Florida
OTHER
Sponsor Role
collaborator
Memorial Sloan Kettering Cancer Center
OTHER
Sponsor Role
collaborator
Dana-Farber Cancer Institute
OTHER
Sponsor Role
collaborator
Gilead Sciences
INDUSTRY
Sponsor Role
collaborator
National Institute of Nursing Research (NINR)
NIH
Sponsor Role
collaborator
Pack Health
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marilyn Hammer, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Alexi Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Elizabeth Arthur, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Jessica Krok-Schoen, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Robin Lally, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Nebraska
Rachael Schmidt, DNP
Role: PRINCIPAL_INVESTIGATOR
Nebraska Medicine
Debra E Lyon, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida College of Nursing
Anneliese Gonzalez, MD
Role: PRINCIPAL_INVESTIGATOR
UTHealth Houston McGovern Medical School
Kathrin Milbury, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Kristen Fessele, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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The University of Florida
Gainesville, Florida, United States
Site Status
ACTIVE_NOT_RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
RECRUITING
University of Nebraska Medical Center
Omaha, Nebraska, United States
Site Status
ACTIVE_NOT_RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
NOT_YET_RECRUITING
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Site Status
ACTIVE_NOT_RECRUITING
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
NOT_YET_RECRUITING
UT Health Houston
Houston, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Marilyn Hammer, PhD
Role: primary
Alexi Wright, MD, MPH
Role: backup
Marilyn Hammer, PhD
Role: backup
Alexi Wright, MD, MPH
Role: backup
Kristen L Fessele, PhD
Role: primary
Kristen L Fessele, PhD
Role: backup
Kathrin Milbury, PhD
Role: primary
Meagan Whisenant, PhD
Role: backup
Meagan Whisenant, PhD
Role: backup
Debu Tripathy, MD
Role: backup
Abbey Kaler, MSN
Role: backup
Kaukab I Jafry, MD, MBBS
Role: primary
Martha Thompson
Role: backup
Anneliese Gonzalez, MD
Role: backup
References
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Related Links
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Other Identifiers
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202101
Identifier Type: -
Identifier Source: org_study_id