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

  • STATUS
    Recruiting
  • End date
    Jan 25, 2025
  • participants needed
    400
  • sponsor
    Eastern Cooperative Oncology Group
Updated on 22 September 2022
cancer
chemotherapy regimen

Summary

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

Description

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.

Details
Condition Breast Cancer, NOS, CNS Primary Tumor, NOS, Cervical Cancer, NOS, Colorectal Cancer, NOS, Leukemia, NOS, Lymphoma, NOS, Miscellaneous Neoplasm, NOS, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, NOS, Testicular Nonseminomatous Germ Cell Tumor, NOS, Thyroid Cancer, NOS, Melanoma, Bone Cancer, NOS
Treatment Questionnaires
Clinical Study IdentifierNCT05108298
SponsorEastern Cooperative Oncology Group
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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