Comprehensive Outcomes for After Cancer Health

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.