Clinical trial NCT05349227: Comprehensive Outcomes for After Cancer Health
Official title: Comprehensive Outcomes for After Cancer Health (COACH): the Feasibility and Impact of an MHealth Augmented Coaching Program for Self-Management in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: Patient Reported Outcome Measures
Physical Activity
Digital Coaching
Microbiome
Wearables
Lead sponsor: Pack Health
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
name: GlaxoSmithKline
name: University of Nebraska
name: Ohio State University Comprehensive Cancer Center
name: The University of Texas Health Science Center, Houston
name: M.D. Anderson Cancer Center
name: University of Florida
name: Memorial Sloan Kettering Cancer Center
name: Dana-Farber Cancer Institute
name: Gilead Sciences
name: National Institute of Nursing Research (NINR)
First posted: 2022-04-27
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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 \&lt;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;

Primary outcomes:
measure: Acceptability of coaching intervention
timeFrame: At 6 months following the start of the coaching intervention
measure: Feasibility of coaching intervention
timeFrame: At 6 months following the start of the coaching intervention
measure: Change in Self-Efficacy for Managing Chronic Disease
timeFrame: Change in baseline perception of self-efficacy at 12 months
Secondary outcomes:
measure: Change in the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 10a
timeFrame: Change in baseline perception of physical function at 12 months
measure: Change in Quality of Life as measured by The Functional Assessment of Cancer Therapy - General v4 (FACT-G)
timeFrame: Change in baseline perception of quality of life at 12 months
measure: Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a
timeFrame: Change in baseline perception of anxiety at 12 months
measure: Change in Depression as measured by the PROMIS Depression Short Form 8a
timeFrame: Change in baseline perception of depression at 12 months
measure: Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a
timeFrame: Change in baseline perception of cognitive impairment at 12 months
measure: Change in Sleep-related Impairment as measured by the PROMIS Sleep related Impairment Short Form 8a
timeFrame: Change in baseline perception of cognitive impairment at 12 months
measure: Change in the PROMIS Brief Sexual Function & Satisfaction Measure Male
timeFrame: Change in baseline perception of sexual function and satisfaction at 12 months among male participants
measure: Change in the PROMIS Brief Sexual Function & Satisfaction Measure Female
timeFrame: Change in baseline perception of sexual function and satisfaction at 12 months among female participants
measure: Change in The Comprehensive Score for Financial Toxicity (COST)
timeFrame: Change in baseline perception of financial toxicity at 12 months
measure: Change in Economic Strain and Resilience in Cancer (ENRICh)
timeFrame: Change in baseline perception of financial toxicity at 12 months
measure: Change in symptom burden as measured by the Edmonton Symptom Assessment System-Revised (ESAS-R)
timeFrame: Change in baseline perception of symptom burden at 12 months
Other outcomes:
measure: Dietary Intake as measured by the Diet History Questionnaire (DHQ) III
timeFrame: Within 2 weeks of microbiome collection at enrollment and month 6
measure: Change in medication adherence for individuals taking maintenance therapies
timeFrame: Change in baseline perception of medication adherence at 12 months
measure: Physical Activity
timeFrame: From date of enrollment up to 12 months
measure: Physical Activity
timeFrame: From date of enrollment up to 12 months
measure: Digital Engagement
timeFrame: From date of enrollment up to 12 months
measure: Gut Microbiota
timeFrame: From date of enrollment to 6 months
measure: Health Care Utilization
timeFrame: From date of enrollment to 12 months
Locations:
city: Gainesville
country: United States
facility: The University of Florida
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: UT Health Houston
state: Texas
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Marilyn Hammer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Alexi Wright, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Elizabeth Arthur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Jessica Krok-Schoen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Nebraska
name: Robin Lally, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nebraska Medicine
name: Rachael Schmidt, DNP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida College of Nursing
name: Debra E Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UTHealth Houston McGovern Medical School
name: Anneliese Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas MD Anderson Cancer Center
name: Kathrin Milbury, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Kristen Fessele, PhD
role: PRINCIPAL_INVESTIGATOR
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