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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
Must not have
Patients must not have basal cell skin carcinoma
Patient must not have a recurrence or second primary cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have basal cell skin cancer.
Select...
I have not had cancer come back or developed a new type of cancer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate completion of PROs among AYAs randomized to Choice PRO vs Fixed PRO.
Other study objectives
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%
Endocrine disorders
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
General disorders and administration site conditions
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system disorders
6%
Respiratory, thoracic and mediastinal disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
269 Previous Clinical Trials
151,489 Total Patients Enrolled
14 Trials studying Melanoma
1,893 Patients Enrolled for Melanoma
John M Salsman, PhDStudy ChairECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials

Media Library

Control arm Clinical Trial Eligibility Overview. Trial Name: NCT05108298 — N/A
Melanoma Research Study Groups: Control arm, Intervention arm
Melanoma 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
~172 spots leftby May 2027
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