Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05108298
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05108298
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment
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 Other: Questionnaires

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : October 31, 2024


Group/Cohort Intervention/treatment
Intervention arm
5 domain-specific HRQOL measures
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.

Control arm
5 pre-selected HRQOL measures
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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).

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adolescent & Young Adult (AYAs) with cancer from participating NCTN, LAPS and NCORP sites, including minority/underserved sites.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108298


Locations
Layout table for location information
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: John M Salsman, PhD    336-713-3613    jsalsman@wakehealth.edu   
Principal Investigator: John M Salsman         
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT05108298    
Other Study ID Numbers: EAQ202
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Sarcoma
Thyroid Neoplasms
Neoplasms, Germ Cell and Embryonal
Bone Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Bone Diseases
Musculoskeletal Diseases
Breast Diseases
Skin Diseases