Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials (NCT05108298) | Clinical Trial Compass
RecruitingNot Applicable
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
United States400 participantsStarted 2021-11-10
Plain-language summary
The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient must be ≥ 18 years and ≤ 39 years of age at registration. Patient must have a histologically confirmed diagnosis of primary cancer of any stage within 12 weeks (84 days) at registration.
Patient must have received, be currently receiving or planning to receive treatment for cancer, including surgery and/or chemotherapy and/or radiation therapy.
Patient must have an ECOG performance status 0-3. Patient must have a life expectancy \>24 months. Patient must be able to complete questionnaires in English. Patient must have internet access through computer, tablet, or smartphone. Patient must have an email address. Patient must have a mobile phone able with text messaging capabilities. Patient must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).
Patient must be able to provide informed consent.
Exclusion Criteria:
Patient must not have a recurrence or second primary cancer. Patients must not have basal cell skin carcinoma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to focus on how young adults fill out self-reported health questionnaires rather than testing a new treatment — can you help me understand how participating would fit alongside my actual cancer treatment plan?
2Since this study covers such a wide range of cancer types, including my specific diagnosis, can you explain whether the way I report my symptoms and experiences here could actually influence how future young adult patients are cared for in ECOG-ACRIN trials?
3I noticed this is listed as Phase NA, which suggests it's more of a research methods or data-collection study than a drug or therapy trial — does that mean there's no direct medical intervention involved, and what would my time commitment actually look like?
4The study compares letting participants choose their own questionnaires versus being assigned fixed ones — can you walk me through what that randomization process means for me and whether either option might feel more burdensome given everything else I'm managing right now?
5Are there standard options for tracking and communicating my symptoms and quality of life outside of this trial that I should consider, and how does joining this study compare to those alternatives in terms of benefit to me personally?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Timeframe: Feasibility at 1 month and acceptability at baseline