Comprehensive Outcomes for After Cancer Health

NCT05349227 | Recruiting

• 2 other identifiers: 202101ZIANR000020-06
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 7

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; 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

Outcome Measures

Primary Outcomes (3)

• Acceptability of 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).

  At 6 months following the start of the coaching intervention

• Feasibility of 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.

  At 6 months following the start of the coaching intervention

• Change in Self-Efficacy for Managing Chronic Disease

  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.

  Change in baseline perception of self-efficacy at 12 months

Secondary Outcomes (11)

• 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

• 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

• Change in Anxiety as measured by the PROMIS Anxiety Short Form 8a

  Change in baseline perception of anxiety at 12 months

• Change in Depression as measured by the PROMIS Depression Short Form 8a

  Change in baseline perception of depression at 12 months

• Change in Cognitive Function as measured by the PROMIS Cognitive Function Short Form 8a

  Change in baseline perception of cognitive impairment at 12 months

Other Outcomes (7)

• Dietary Intake as measured by the Diet History Questionnaire (DHQ) III

  Within 2 weeks of microbiome collection at enrollment and month 6

• Change in medication adherence for individuals taking maintenance therapies

  Change in baseline perception of medication adherence at 12 months

• Physical Activity

  From date of enrollment up to 12 months

Study Arms (3)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Digital Health Coaching Program; Device: Fitbit

Wait List Control Group

OTHER

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.

Behavioral: Digital Health Coaching Program; Device: Fitbit

Household Healthy Participants

NO INTERVENTION

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 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.

Intervention Group; Wait List Control Group

Fitbit 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.

Intervention Group; Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have primary diagnosis of cancer;
• Are within 1 year of completion of primary therapy OR have a diagnosis of metastatic cancer
• 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
• 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).
• Are aged 18 years and older;
• Can read and consent to participate in the trial;
• Can read and speak English;
• Can complete study follow-up at pre-specified intervals;
• 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.

You may not qualify if:

• 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;
• Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their provider)
• Have a life expectancy of \<6 months, and/or
• 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:
• Be adults aged 18 years or older or the age of majority in their state of residence, whichever is older.
• Must reside in the same dwelling as the patient participant
• Can read and consent to participate in the trial;
• Can read and speak English;
• Can complete study follow-up at pre-specified intervals;

Sponsors & Collaborators

• Pack Health: lead
• Daiichi Sankyo: collaborator
• GlaxoSmithKline: collaborator
• University of Nebraska: collaborator
• Ohio State University Comprehensive Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator
• University of Florida: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Dana-Farber Cancer Institute: collaborator
• Gilead Sciences: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (7)

The University of Florida

Gainesville, Florida, 32610, United States

ACTIVE NOT RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

ACTIVE NOT RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

NOT YET RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

ACTIVE NOT RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

UT Health Houston

Houston, Texas, 77030, United States

RECRUITING

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Related Links

• National Cancer Institute Statistics and Graphs

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Lung Neoplasms; Stomach Neoplasms; Endometrial Neoplasms; Head and Neck Neoplasms; Prostatic Neoplasms; Neoplasm Metastasis; Motor Activity

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Uterine Neoplasms; Uterine Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marilyn Hammer, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Alexi Wright, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Elizabeth Arthur, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Jessica Krok-Schoen, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Robin Lally, PhD

  The University of Nebraska

  PRINCIPAL INVESTIGATOR

• Rachael Schmidt, DNP

  Nebraska Medicine

  PRINCIPAL INVESTIGATOR

• Debra E Lyon, PhD

  University of Florida College of Nursing

  PRINCIPAL INVESTIGATOR

• Anneliese Gonzalez, MD

  UTHealth Houston McGovern Medical School

  PRINCIPAL INVESTIGATOR

• Kathrin Milbury, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Kristen Fessele, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly J Brassil, PhD

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Jennifer Loftis, DNP

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 27, 2022
• Study Start: June 23, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)