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

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ClinicalTrials.gov Identifier: NCT05108298
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE October 5, 2021
First Posted Date  ICMJE November 4, 2021
Last Update Posted Date September 22, 2022
Actual Study Start Date  ICMJE October 28, 2021
Estimated Primary Completion Date January 25, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2021)
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO. [ Time Frame: Feasibility at 1 month and acceptability at baseline ]
Evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 3, 2021)
  • Evaluate AYAs' HRQOL priorities and HRQOL PRO trajectories [ Time Frame: Through study completion, an average of 1 year ]
    The goal of the ranking exercise is to evaluate the importance of HRQOL domain rank choice PROs and examine their changes over time.
  • Access and Utilization [ Time Frame: Assessed up to 52 months ]
    To evaluate access to and utilization of psychosocial and financial resources using items from the Consumer-Based Cancer Care Value Index (CCVI).
  • To summarize AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers. [ Time Frame: Assessed up to 52 months ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Official Title  ICMJE Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Brief Summary The purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Other - Patients will complete questionnaires online through EASEE-PRO. There will be a set of fixed questionnaires at each timepoint for both arms.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • 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
Intervention  ICMJE Other: Questionnaires
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.
Study Arms  ICMJE
  • Intervention arm
    5 domain-specific HRQOL measures
    Intervention: Other: Questionnaires
  • Control arm
    5 pre-selected HRQOL measures
    Intervention: Other: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2021)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 25, 2025
Estimated Primary Completion Date January 25, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05108298
Other Study ID Numbers  ICMJE EAQ202
NCI-2021-07529 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAQ202 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EAQ202 ( Other Identifier: DCP )
EAQ202 ( Other Identifier: CTEP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eastern Cooperative Oncology Group
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: John M Salsman, PhD ECOG-ACRIN Cancer Research Group
PRS Account Eastern Cooperative Oncology Group
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP