Digital health coaching for cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the feasibility and outcomes of a digital health coaching intervention for individuals who have completed primary cancer therapy. Up to 625 participants with various cancer diagnoses will be enrolled across multiple clinical sites in a randomized wait-list control design. Participants in the intervention group will receive six months of digital coaching, while the control group will receive monitoring for six months before starting the coaching. The study aims to assess the impact of digital health coaching on patient-reported outcomes, clinical outcomes, and microbiome data.

Why it matters

Who can join: the full rules

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 \<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;

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• UT Health Houston
  Houston, Texas, United States Recruiting
• The University of Florida
  Gainesville, Florida, United States Active not recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Active not recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Not yet recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Active not recruiting

Study contacts

• Principal investigator: Marilyn Hammer, PhD — Dana-Farber Cancer Institute
• Study coordinator: Kelly J Brassil, PhD
• Email: dgxpharesearch@questdiagnostics.com
• Phone: 205-721-7542

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.