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Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05108298
Enrollment
500
Registered
2021-11-04
Start date
2021-11-10
Completion date
2027-05-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

Brief summary

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.

Detailed description

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.

Interventions

OTHERQuality-of-Life Assessment

Complete questionnaires

OTHERQuestionnaire Administration

Complete questionnaires

Sponsors

ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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 not have a recurrence or second primary cancer * Patients must not have basal cell skin carcinoma * 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 Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Patient must have a life expectancy \> 24 months * Patient must be able to complete questionnaires in English or in Spanish * 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 * Participation in clinical trials is not an exclusionary criterion in EAQ202. Patients may be dually enrolled in EAQ202 as well as in therapeutic trials, including those involving checkpoint inhibitors * NOTE: We understand that some therapeutic trials may also collect PRO data (e.g., the cross-National Clinical Trials Network \[NCTN\] S1826 study in which ECOG-ACRIN is participating), thus creating a potential for overburdening patients. We will be attentive to informing all patients of this potential overburdening as they consider a voluntary decision to register for EAQ202. We will coordinate with the PRO chair(s) of the therapeutic studies to ensure that the integrity of the PRO analyses be preserved

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of completing patient reported outcomes (PROs)At 1 monthWill 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.
Acceptability of completing PROsBaselineWill 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJohn M Salsman

ECOG-ACRIN Cancer Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026