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Quality of Life Intervention for Early-Stage Lung Cancer

N/A

Recruiting

Led By Anurag K Singh

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years of age

Diagnosed with biopsy-proven stage I-II non-small cell lung cancer (NSCLC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

Study Summary

This trial is studying whether a quality of life intervention can help patients with early-stage lung cancer who are deciding between surgery and radiation therapy.

Who is the study for?

This trial is for adults over 18 with early-stage lung cancer (stage I-II NSCLC) who can consent in English and are eligible for both surgery and SBRT. It's not suitable for those only eligible for one treatment, at later stages of cancer, pregnant women, or individuals unable to follow the study plan.Check my eligibility

What is being tested?

The trial examines a quality of life intervention aimed at helping patients choose between surgery and SBRT. The goal is to reduce regret over their decision and improve satisfaction by providing them with quality of life outcome data during the decision-making process.See study design

What are the potential side effects?

Since this trial involves best practices, informational interventions, and questionnaires rather than medical treatments or drugs, there are no direct physical side effects associated with participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with early-stage non-small cell lung cancer.

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I am a candidate for both surgery and SBRT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decision regret

Secondary outcome measures

Difference in consideration of regret

Quality of Life (EORTC QLQ-C30)

Quality of Life (QOL)

Side effects data

From 2020 Phase 3 trial • 177 Patients • NCT01817075

13%

Rash maculo-papular

10%

Skin and subcutaneous tissue disorders - Other, specify

Mucositis oral

Sepsis

Skin ulceration

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CHG Cleansing Wipe)

Arm II (Control)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A (QOL fact sheet)Experimental Treatment2 Interventions

Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).

Group II: Group B (usual care)Active Control2 Interventions

Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,657 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,485 Total Patients Enrolled

Anurag K SinghPrincipal InvestigatorRoswell Park Cancer Institute

5 Previous Clinical Trials

1,764 Total Patients Enrolled

Media Library

Questionnaire Administration Clinical Trial Eligibility Overview. Trial Name: NCT05292521 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Group A (QOL fact sheet), Group B (usual care)

Non-Small Cell Lung Cancer Clinical Trial 2023: Questionnaire Administration Highlights & Side Effects. Trial Name: NCT05292521 — N/A

Questionnaire Administration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05292521 — N/A

Frequently Asked Questions

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

Are there vacancies still available for individuals who are interested in participating in this experiment?

"As indicated on clinicaltrials.gov, this research project is no longer looking for participants since it was last updated November 3rd 2022. Although the study has concluded its recruitment phase, 2050 other trials are currently seeking volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer

2023. "Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05292521.