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Questionnaire Choice for Cancer Data Quality

N/A
Recruiting
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a mobile phone able with text messaging capabilities
Patient must have an ECOG performance status 0-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing if letting people choose which health questionnaire to fill out leads to more people filling it out and if they find it more acceptable.

Who is the study for?
This trial is for young adults aged 18-39 with a recent diagnosis of various cancers like leukemia, breast cancer, or melanoma. They must be able to use text messaging, provide consent, and complete English questionnaires online. Those with cognitive impairments, recurrences or second primary cancers are excluded.Check my eligibility
What is being tested?
The study tests how well adolescents and young adults can report their own health status using two different methods: Choice PRO where they choose what to report vs Fixed PRO where the topics are pre-selected. It checks which method is easier and more reliable for them.See study design
What are the potential side effects?
Since this trial involves completing questionnaires rather than medical treatments, there aren't typical side effects as seen in drug trials. Participants may experience fatigue or emotional discomfort while reflecting on their health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a mobile phone that can send and receive texts.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
I am between 18 and 39 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Other outcome measures
Access and Utilization
Evaluate AYAs' HRQOL priorities and HRQOL PRO trajectories
To summarize AYAs' preferences for how their PRO data should be shared with them, their families, and/or their providers.

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Gastrointestinal disorders
6%
Investigations
6%
Infections and infestations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Cardiac disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
5 domain-specific HRQOL measures
Group II: Control armExperimental Treatment1 Intervention
5 pre-selected HRQOL measures

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
151,195 Total Patients Enrolled
27 Trials studying Leukemia
12,490 Patients Enrolled for Leukemia
John M Salsman, PhDStudy ChairECOG-ACRIN Cancer Research Group

Media Library

Control arm Clinical Trial Eligibility Overview. Trial Name: NCT05108298 — N/A
Leukemia Research Study Groups: Control arm, Intervention arm
Leukemia Clinical Trial 2023: Control arm Highlights & Side Effects. Trial Name: NCT05108298 — N/A
Control arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this clinical experiment?

"Affirmative. According to the information found on clinicaltrials.gov, this research endeavour is actively seeking qualified participants and has been since October 28th 2021. This trial will include 400 patients in 100 different recruiting locations with updates occurring as recently as September 20th 2022."

Answered by AI

How many geographical locations are providing access to this clinical experiment?

"This medical trial is currently accruing participants at Mount Carmel East Hospital in Columbus, Ohio, OhioHealth Marion General Hospital in Marion, Colorado, and Knox Community Hospital in Mount Vernon Delaware. In total there are 100 other enrolment sites for this clinical research."

Answered by AI

Is this research endeavor presently seeking participants?

"As indicated by clinicaltrials.gov, this trial is still recruiting patients. It was first posted on October 28th 2021 and revised most recently on September 20th 2022."

Answered by AI

Are individuals of mature age invited to join in this clinical trial?

"The study requires potential enrollees to be between 18 and 39 years of age. Conversely, there are 551 trials open for minors and 5416 studies with participants over the age of 65."

Answered by AI

Might I be eligible to participate in this research?

"To successfully join this medical trial, applicants must possess a diagnosis of leukemia and be in the 18 - 39 years old age bracket. This clinical trial hopes to accrue 400 participants."

Answered by AI

Who else is applying?

What site did they apply to?
Sunrise Hospital and Medical Center
Wellmont Holston Valley Hospital and Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I wanted to help with research studies to help others.
PatientReceived 1 prior treatment
~69 spots leftby Nov 2024