New treatment option for Ovarian Cancer
Official title Comprehensive Outcomes for After Cancer Health
ClinicalTrials.gov ID: NCT05349227
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- For individuals with metastatic cancer, individuals may be included provided they completed primary therapy for a de novo diagnosis of metastatic...
- Are aged 18 years and older;
You likely can't join if
- Have a cognitive impairment (as assessed by their provider) that would prohibit the individual from engaging with the digital health coaching program...
- Have a neurologic, musculoskeletal, or other comorbid condition that would impede their ability to engage in physical activity (as assessed by their...
- 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...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States; Columbus, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.