Comprehensive Outcomes for After Cancer Health

Launched by PACK HEALTH · Apr 21, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Comprehensive Outcomes for After Cancer Health," is looking at how digital health coaching can help people who have completed their primary cancer treatments, such as chemotherapy or surgery. The study will involve up to 625 participants with various types of cancers, including ovarian, breast, lung, and others. Participants will be split into two groups: one will receive six months of digital coaching right away, while the other will first be monitored for six months before starting the coaching. Throughout the study, both groups will be asked to share information about their health and will provide samples for analysis to help researchers understand the impact of the coaching program.

To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with cancer, and completed their primary treatment within the past year, or have metastatic cancer (cancer that has spread). They should also have access to a smartphone or tablet for the coaching sessions. Participants can expect to engage in regular health monitoring and receive support through the digital platform, helping them improve their health and well-being after cancer treatment. This study will provide valuable insights into how digital health tools can benefit cancer survivors.

Gender

ALL

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 \<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;