Measuring Health Related Quality of Life in AYAs (NCT03482778) | Clinical Trial Compass
CompletedNot Applicable
Measuring Health Related Quality of Life in AYAs
United States165 participantsStarted 2018-02-09
Plain-language summary
AIM1a:
AYAs with cancer experience many challenges that impact their health-related quality of life (HRQOL) but few measures adequately capture AYAs' HRQOL in valid and reliable ways. The main goal of the study is to expand the use of the Patient-Reported Outcome Measurement Information System (PROMIS) to provide valid and reliable assessment of important HRQOL concerns for AYAs. The study team will do this by validating existing PROMIS measures and developing and validating new measures of financial distress, fertility/parenthood concerns, and body image concerns for AYAs with cancer.
AIM1b:
Investigators have developed conceptual frameworks and created item pools for body image, fertility, and financial burden domains and are ready to proceed with the next aim of our measure development work, cognitive interview testing.
Who can participate
Age range
15 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.
AYA Patients:
Inclusion Criteria:
* 15 to 39 years of age
* Diagnosed with cancer at 15 to 39 years of age
* Able to read and understand English
* Have a new cancer diagnosis and are receiving curative treatment OR are currently 0 to 5 years post-treatment
Exclusion Criteria:
* Diagnosed with basal cell skin cancer
* Experienced a cancer recurrence
* Currently receiving palliative or hospice care
* Had an infertility diagnosis prior to their cancer diagnosis
* Report a significant psychiatric history
AYA Caregivers:
Inclusion Criteria:
* 18 years or age or older.
* Able to read and understand English
* Have a child/ward/partner for whom they are providing care and at least partly financially responsible.
* Have a child/ward/partner who is 15 to 25 years of age and meets the other criteria as an eligible AYA participant based on the AYA patient inclusion and exclusion criteria.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Number and type of themes for financial burden - Aim1A
Timeframe: Baseline
2
Number and type of themes for body image - Aim1A
Timeframe: Baseline
3
Number and type of themes for fertility and future parenthood - Aim1A
Timeframe: Baseline
4
Number of Participants with Adequate Understanding of Trial Themes Through Cognitive Interviews