NCT Number: NCT05108298
The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Interested in participating?
Request Info18 year–39 year
All sexes
Interventional
Not applicable
Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
Primary Aim: Conduct a pilot randomized controlled trial with AYAs to determine the feasibility and acceptability of completing PROs informed by AYAs' priorities. AYAs will be consented and randomized to select five HRQOL domains from a dashboard (Choice PRO) at each assessment period or to five standard HRQOL domains (Fixed PRO; physical function, pain, cognitive function, social support, finances) at each assessment period. AYAs will complete baseline, 1-, 3-, 6-, and 12-month assessments which will include a combination of CATs and static short forms. Feasibility will be operationalized as ≥ 75% completed PROs and ≥ 75% acceptability. Feasibility and acceptability will be compared between AYAs randomized to Choice PRO vs Fixed PRO. Adherence boosters (reminder calls, text messages) will be used to minimize missing data and evaluated as moderators.
Exploratory Aim: Solicit AYA preferences for how their PRO data should be shared with them and/or their providers. To inform future research, AYAs will be asked if and how participants want their PRO data to be used by their medical teams as well as if and how participants want their PRO data to be shared with them and their families.
The investigators anticipate PROMIS CATs will increase capacity for PRO data capture, AYAs randomized to Choice PRO, who are given the opportunity to choose which PRO domains to complete, will have less missing data. The investigators expect the majority of AYAs will want PRO feedback for themselves, their families, and their providers. Findings will promote and sustain the inclusion of PROs in clinical and supportive care trials, providing AYA's a voice and informing future patient-centered care tailored to the diverse needs of AYAs. By offering AYAs the opportunity to choose which PRO domains to complete based on relevance to their health-related quality of life, as opposed to completing domains pre-determined by the research team, the investigators raise the patient-centeredness of investigators assessment approach.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Patients will complete questionnaires online through EASEE-PRO. There will be a set of fixed questionnaires at each timepoint for both arms. The patients will be asked to rank the 15 types of PROs according to their importance. The participants randomized to the choice arm will be asked to choose 5 of the 15 PROs to complete. The participants randomized to the fixed arm will be given a fixed 5 of the 15 PROs at each time point.
Time frame: Feasibility at 1 month and acceptability at baseline
Evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Time frame: Through study completion, an average of 1 year
The goal of the ranking exercise is to evaluate the importance of HRQOL domain rank choice PROs and examine their changes over time.
Time frame: Assessed up to 52 months
To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI).
Time frame: Assessed up to 52 months
Solicit AYAs preferences with regard to possible applications for their PRO data, including sharing PRO data with their medical teams and/or their families, and providing participants with summary feedback.
Eastern Cooperative Oncology Group
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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