What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and difficulty swallowing. Immunotherapy, such as nivolumab or pembrolizumab, can result in immune-related side effects like rash, diarrhea, and inflammation of organs. These treatments can significantly impact the quality of life, making it essential for patients to discuss potential side effects with their healthcare providers to make informed decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), particularly focusing on immunotherapy and chemotherapy combinations. Pembrolizumab, an anti-PD-1 therapy, has been approved in combination with pemetrexed and platinum chemotherapy for previously untreated metastatic nonsquamous NSCLC, as demonstrated in the KEYNOTE-189 trial. Atezolizumab, an anti-PD-L1 therapy, has also been approved in combination with bevacizumab and chemotherapy for first-line treatment of metastatic nonsquamous NSCLC, as shown in the IMpower150 trial. Additionally, durvalumab, another PD-L1 antibody, is approved for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiotherapy.

What other types of research exist?

Promising novel alternatives for informed decision-making in NSCLC patients considering treatment in 2024 include the integration of new chemotherapy agents into multimodality therapy, advancements in immunotherapy, and the use of personalized medicine approaches such as genomic profiling to tailor treatments. Additionally, the development of predictive models for treatment outcomes and the use of artificial intelligence to analyze patient data and predict responses to various therapies are also emerging as valuable tools.

← Back to Search

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)

Must not have

Eligible for palliative-intent treatments or supportive care only

Diagnosed with stage III-IV NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how providing quality of life information affects decision-making in early-stage lung cancer patients choosing between surgery and radiation therapy. The goal is to help patients make better-informed decisions and feel more satisfied with their care.

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.

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.

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

Select...

I am 18 years old or older.

Select...

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

Select...

I am a candidate for both surgery and SBRT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am only eligible for treatments aimed at easing symptoms.

Select...

My lung cancer is at an advanced stage (III or IV).

Select...

I am eligible for either surgery or SBRT, but not both.

Select...

I have difficulty making decisions due to cognitive impairment.

Select...

I am under the age of 18.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decision regret

Secondary study objectives

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)

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

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapy uses drugs that specifically target genetic mutations or proteins involved in cancer cell growth, offering a more precise approach with potentially fewer side effects. Immunotherapy enhances the body's immune system to recognize and destroy cancer cells. Understanding these mechanisms helps NSCLC patients and their doctors make informed decisions about treatment options, balancing effectiveness with quality of life.

Clinical effectiveness and cost-effectiveness of first-line chemotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer: a systematic review and economic evaluation.