This clinical trial gathers information about adolescents and young adults (AYA) and patient reported outcomes data in Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) trials to improve the collection of AYA patient reported outcomes. This study may help doctors understand the needs of adolescent and young adult cancer patients.
PRIMARY OBJECTIVE: I. To evaluate feasibility and acceptability of completing patient reported outcomes (PROs) among AYAs randomized to Choice PRO versus (vs) Fixed PRO. EXPLORATORY OBJECTIVES: I. To evaluate AYAs' health-related quality of life (HRQOL) priorities and HRQOL PRO trajectories. II. To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI). III. To summarize AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (CHOICE PRO): Patients rank 15 HRQOL domains from most important to least important and choose 5 HRQOL domains to complete over 13-18 minutes at baseline, 1, 3, 6 and 12 months. ARM II (FIXED PRO): Patients rank 15 HRQOL domains from most important to least important and complete 5 pre-selected HRQOL domains over 13-18 minutes at baseline, 1, 3, 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
500
Complete questionnaires
Complete questionnaires
Feasibility of completing patient reported outcomes (PROs)
Will be defined as \>= 75% completed PROs at one-month. Feasibility will be compared between two arms using the two-sample proportion tests based on two binomial distributions. Fisher's exact method will be used to calculate the p value. Potential moderators will include sociodemographic information (i.e., Protocol for Responding to \& Assessing Patients' Assets, Risks \& Experiences \[PRAPARE\] form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting). Their effects will be evaluated using the logistic regression method with feasibility modeled as the binary response.
Time frame: At 1 month
Acceptability of completing PROs
Will be defined as \>= 75% completed PROs at baseline. Acceptability will be compared between two arms using the two-sample proportion tests based on two binomial distributions. Fisher's exact method will be used to calculate the p value. Potential moderators will include sociodemographic information (i.e., PRAPARE form, geocoding, etc.), health literacy, adherence boosters (reminder calls, text messages), cancer type, treatment plan, and location of care (inpatient hospital or outpatient clinic setting). Their effects will be evaluated using the logistic regression method with acceptability modeled as the binary response.
Time frame: Baseline
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