Comprehensive Outcomes for After Cancer Health

Not Applicable

Recruiting

• Conditions: Ovarian Cancer; Breast Cancer; Lung Cancer; Gastric Cancer; Survivorship; Endometrial Cancer; Head and Neck Cancers; Prostate Cancers; Geriatric Oncology; Metastatic Breast Cancer
• Interventions: Behavioral: Digital Health Coaching Program; Device: Fitbit

• Registration Number: NCT05349227
• Lead Sponsor: Pack Health

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 500 individuals with diverse cancer diagnoses will be enrolled across up to 5 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 to1500 individuals with diverse tumor types who have completed primary treatment and are within 1 year of diagnosis. Each of up to 15 collaborating sites will enroll 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.

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-06-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-12
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 660

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

   a. 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

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.

8. Agree to wear and have data collected from an activity tracking device

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Group	Digital Health Coaching Program	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.
Wait List Control Group	Fitbit	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.
Intervention Group	Fitbit	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.
Wait List Control Group	Digital Health Coaching Program	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of coaching intervention	At 6 months following the start of the coaching intervention	A 3-item questionnaire evaluating the following: 1) The digital health coaching program is easy to participate in; 2) the digital health coaching program is useful to me; 3) the digital health coaching program is relevant to my survivorship experience. Responses will be provided on a 10-point Likert scale ranging from 1 (Not at all) to 10 (Very Much).
Change in Self-Efficacy for Managing Chronic Disease	Change in baseline perception of self-efficacy at 12 months	A 6-item instrument measures how confident an individual is in engaging in certain health management activities. Responses are provided on a 10-point scale ranging from 1(not at all confident) to 10 (totally confident). A mean score is calculated for the instrument with a higher score indicating higher self-efficacy.
Feasibility of coaching intervention	At 6 months following the start of the coaching intervention	A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program completing the 6-months of engagement post-enrollment.

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a	Change in baseline perception of cognitive impairment at 12 months	An 8-item instrument measuring indicators of cognitive function with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater cognitive impairment.
Change in Quality of Life as measured by The Functional Assessment of Cancer Therapy - General v4 (FACT-G)	Change in baseline perception of quality of life at 12 months	A 27-item instrument using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much) to measure QoL across four dimensions: physical, social/family, emotional and functional. The FACT-G, validated for use with individuals with diverse cancer types, in addition to condition specific items as available by tumor type.
Change in Depression as measured by the PROMIS Depression Short Form 8a	Change in baseline perception of depression at 12 months	An 8-item instrument measuring indicators of depression with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater depression.
Change in Sleep-related Impairment as measured by the PROMIS Sleep related Impairment Short Form 8a	Change in baseline perception of cognitive impairment at 12 months	An 8-item instrument measuring indicators of sleep-related impairment with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater sleep-related impairment.
Change in Economic Strain and Resilience in Cancer (ENRICh)	Change in baseline perception of financial toxicity at 12 months	An 16-item instrument measuring the financial toxicity of cancer treatment. The first 15 items are rated on an 11-point scale ranging from 0 (lowest financial toxicity burden) to 10 (most severe financial toxicity burden). A final item asks individuals to rank their overall financial situation at the time of the survey compared to prior to their cancer diagnosis, using a 5-point response ranging from much better to much worse.
Change in the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Physical Function 10a	Change in baseline perception of physical function at 12 months	A 12-item instrument assessing respondents' abilities to perform physical tasks and activities of daily living. Items are scored on 5-point Likert scales, with higher scores indicating higher physical functioning.
Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a	Change in baseline perception of anxiety at 12 months	An 8-item instrument measuring indicators of anxiety with a recall period over the last 7 days. Responses are provided on a 5-point scale ranging from 1(never) to 5 (always). A summed score is calculated for the instrument with a higher score indicating greater anxiety.
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Male	Change in baseline perception of sexual function and satisfaction at 12 months among male participants	An 11-item instrument measuring indicators of male sexual function and satisfaction with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 10 domains: interest in sexual activity, orgasm ability, orgasm satisfaction, oral discomfort, oral dryness, satisfaction with sex life, erectile function. For each item on the instrument a higher score indicates more of the concept being described.
Change in the PROMIS Brief Sexual Function & Satisfaction Measure Female	Change in baseline perception of sexual function and satisfaction at 12 months among female participants	A 14-item instrument measuring sexual function and satisfaction for women with a recall period over the last 30 days. Responses are provided on various 2- to 10-point scales across 7 domains: interest in sexual activity, lubrication for sexual activity, orgasm ability, orgasm pleasure, oral discomfort, oral dryness, satisfaction with sex life, vaginal discomfort, vulvar discomfort-clitoral, vulvar discomfort-labial. For each item on the instrument a higher score indicates more of the concept being described.
Change in symptom burden as measured by the Edmonton Symptom Assessment System-Revised (ESAS-R)	Change in baseline perception of symptom burden at 12 months	A 10-item instrument measuring the presence of commonly observed symptoms in individuals with a cancer diagnosis (9 specific items and 1 allowing entry of other problems). Responses for a recall period of the last 24 hours are recorded on an 11-point scale ranging from 0 (none/not present) to 10 (worst possible).
Change in The Comprehensive Score for Financial Toxicity (COST)	Change in baseline perception of financial toxicity at 12 months	An 11-item instrument measuring the financial toxicity of cancer treatment utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

Trial Locations

Locations (7)

The University of Florida; 🇺🇸 Gainesville, Florida, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

UT Health Houston; 🇺🇸 Houston, Texas, United States