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Improving Adolescent and Young Adult Self-Reported Data in Cancer Trials

This study aims to find the best way for young people (ages 18-39) with cancer to share information about their health and well-being. It compares two approaches: one where you choose which health topics to report on (Choice PRO) and another where you report on a fixed set of topics (Fixed PRO). Researchers want to see if it's practical and acceptable for young adults to complete these health questionnaires. To join, you must be 18-39 years old with a recently diagnosed cancer and be receiving or planning to receive cancer treatment. The study will be considered successful if at least 75% of the questionnaires are completed and found acceptable by participants. The current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two ways of collecting health information from participants, with a planned enrollment of 400 individuals.
What's involved
You would complete questionnaires online at the start of the study, and then again at 1, 3, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for up to 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05108298

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

Active, Not Recruiting
EARLY_PHASE1Ages 18–39InterventionalHealth services
ECOG-ACRIN Cancer Research Group
~500 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
0 of 347 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of completing patient reported outcomes (PROs)
Measured over At 1 month
+1 more outcome measured

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

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NCT05108298

Where you'd take part

This study runs at 347 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesotano site contact published

  • Adena Regional Medical Center

    Chillicothe, Ohiono site contact published

  • AdventHealth Littleton

    Littleton, Coloradono site contact published

  • AdventHealth Parker

    Parker, Coloradono site contact published

  • AdventHealth Porter

    Denver, Coloradono site contact published

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraskano site contact published

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraskano site contact published

  • Alegent Health Lakeside Hospital

    Omaha, Nebraskano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John M Salsman · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

What this trial measures

  • Feasibility of completing patient reported outcomes (PROs)At 1 month

    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.

  • Acceptability of completing PROsBaseline

    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.