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

ConditionsBreast Cancer, NOSCNS Primary Tumor, NOSCervical Cancer, NOSColorectal Cancer, NOSLeukemia, NOSLymphoma, NOSMiscellaneous Neoplasm, NOSNon-Rhabdomyosarcoma Soft Tissue Sarcoma, NOSTesticular Nonseminomatous Germ Cell Tumor, NOSThyroid Cancer, NOSMelanomaBone Cancer, NOS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorEastern Cooperative Oncology Group

About this trial

The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armOther 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.

Evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.

Time frame
Feasibility at 1 month and acceptability at baseline

Secondary outcomes

Other outcomes

1

Evaluate AYAs' HRQOL priorities and HRQOL PRO trajectories

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
Through study completion, an average of 1 year
2

Access and Utilization

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
3

To summarize AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers.

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.

Time frame
Assessed up to 52 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Cooperative Oncology Group

Lead sponsor

Source ClinicalTrials.gov
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