Quality of Life Intervention for Early-Stage Lung Cancer

Overseen by Anurag K. Singh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Stage III-IV NSCLC, Pregnancy, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Quality of Life Intervention treatment for early-stage lung cancer?

Research highlights the importance of quality of life (QoL) as a key outcome for lung cancer patients, suggesting that interventions focusing on QoL can be beneficial. Studies emphasize the need for effective QoL assessments and interventions to improve patient care, indicating that such treatments can help address the debilitating effects of lung cancer and its treatments. ^{1 2 3 4 5}

Is the Quality of Life Intervention safe for humans?

The research articles reviewed do not provide specific safety data for the Quality of Life Intervention in humans, as they focus on the impact of quality of life assessments and patient-reported outcomes in cancer clinical trials. ^{3 6 7 8 9}

How does the quality of life treatment for early-stage lung cancer differ from other treatments?

This treatment focuses on improving the quality of life for early-stage lung cancer patients, which is often overlooked in traditional treatments that primarily aim to extend survival. It uses specific quality of life measurement tools to assess and address patients' well-being, making it unique compared to standard chemotherapy or radiation therapies that do not typically prioritize quality of life as a primary outcome. ^{3 10 11 12 13}

Research Team

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

Able to provide informed consent in English

I am 18 years old or older.

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

Exclusion Criteria

I am only eligible for treatments aimed at easing symptoms.

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

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Consult

Patients receive either a QOL intervention fact sheet or usual care during the initial consult 4 weeks prior to surgery or SBRT

4 weeks

1 visit (in-person)

Treatment

Patients undergo standard of care surgery or stereotactic body radiation therapy (SBRT)

Varies based on treatment modality

Follow-up

Participants are monitored for decision regret and quality of life at 1, 3, and 6 months after treatment

6 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• Quality of Life Intervention (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Group A (QOL fact sheet) Experimental Treatment 2 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 Control 2 Interventions

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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Dr. Julia Faller

Roswell Park Cancer Institute

Chief Medical Officer since 2024

DO from an unspecified institution

Dr. Candace S. Johnson

Roswell Park Cancer Institute

Chief Executive Officer since 2015

PhD in Immunology from The Ohio State University

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Crystal S. Denlinger

National Comprehensive Cancer Network

Chief Executive Officer since 2023

MD, FACP

Robert W. Carlson

National Comprehensive Cancer Network

Chief Medical Officer since 2013

MD

Findings from Research

A survey of 660 lung cancer patients revealed that the most important quality of life issues for them included overall quality of life, maintaining independence, and the ability to perform normal activities, rather than just focusing on symptoms.

The study highlights that patient-reported outcome measures need to encompass broader quality of life concerns, as over 90% of patients rated global issues as 'very important' or 'important', indicating a need for more comprehensive assessment tools in lung cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based determination of issues affecting quality of life and patient-reported outcomes in lung cancer: results of a survey of 660 patients. Gralla, RJ., Hollen, PJ., Msaouel, P., et al.[2022]

Quality of life (QOL) is a crucial outcome for lung cancer patients, and recent advancements in patient-reported outcomes have improved how QOL is assessed in clinical trials and practice.

The review emphasizes the importance of using valid and reasonable QOL measures in early-stage lung cancer research, providing an algorithm for selecting appropriate assessments to optimize patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metrics to assess quality of life after management of early-stage lung cancer. Sloan, JA.[2023]

In a phase III trial involving 939 patients with advanced nonsquamous non-small-cell lung cancer, those treated with pemetrexed-carboplatin-bevacizumab reported significantly less neurotoxicity compared to those receiving paclitaxel-carboplatin-bevacizumab, indicating a better quality of life in terms of neurotoxic side effects.

Patients' baseline quality of life scores were found to be strong predictors of overall survival, suggesting that assessing quality of life can provide valuable insights into treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Spigel, DR., Patel, JD., Reynolds, CH., et al.[2015]

A study involving 543 patients with early-stage non-small-cell lung cancer (NSCLC) revealed that while 85% felt well prepared for postsurgical recovery, a significant number still felt uninformed about what to expect, indicating a gap in communication between surgeons and patients.

Patients who felt very well prepared for their recovery had significantly higher quality of life and social support scores, suggesting that better communication and preparation could enhance post-surgery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-Stage Lung Cancer Patients' Perceptions of Presurgical Discussions. Schwartz, RM., Yip, R., You, N., et al.[2022]

In a survey of 61 lung cancer survivors and caregivers, 74.5% prioritized cancer cure as the most important treatment goal, followed by quality of life during and after treatment.

70% of respondents considered treatment that leads to complete dependence on others or being confined to bed as unsuccessful, highlighting the need for physicians to discuss treatment goals and potential toxicities with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivor and Caregiver Expectations and Preferences Regarding Lung Cancer Treatment. Wieland, J., Hoppe, BS., Rausch-Osian, SM., et al.[2022]

Quality-of-life (QL) assessments in cancer clinical trials may be significantly influenced by local conditions and the environment in which data is collected, rather than just patient compliance with questionnaires.

Nurses involved in QL assessments reported that their interactions and experiences during data collection could impact patients' self-estimation of quality of life, suggesting that these factors should be systematically considered in trial methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life assessment in cancer clinical trials: an intervention by itself? Bernhard, J., Gusset, H., Hürny, C.[2019]

Quality-of-life (QOL) measures are becoming essential in oncology clinical trials, with the FDA suggesting that positive QOL outcomes can be a basis for drug approval, especially when survival benefits are not evident.

Clinical trial protocols must clearly outline hypotheses, select validated QOL assessment tools, and include detailed statistical plans to handle missing data, ensuring that QOL evaluations are robust and meaningful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life end points in cancer clinical trials: the U.S. Food and Drug Administration perspective. Beitz, J., Gnecco, C., Justice, R.[2007]

Patient-reported outcome (PRO) measures, such as quality of life assessments, are increasingly recognized as essential for evaluating treatment effectiveness in lung cancer clinical trials, which is crucial given lung cancer's high incidence and low survival rates.

The article highlights the importance of integrating electronic PRO reporting and interventions, as well as exploring the relationship between PROs and immunotherapy, to enhance clinical decision-making and precision health in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer. Xiao, C., Hurst, N., Movsas, B.[2021]

Patient-reported outcomes (PRO) are valuable indicators of health-related quality of life (QOL) in lung cancer patients and can significantly influence treatment management and decision-making.

The EORTC QLQ-C30 and its lung cancer-specific module QLQ-LC13 are the most commonly used PRO measures in clinical trials, and they have shown independent prognostic value for predicting survival, although their implementation in daily practice, especially in Japan, remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient-Reported Outcome(PRO)to Measure Health-Related QOL in Lung Cancer Patients]. Sone, S., Hase, K., Takezaki, A., et al.[2019]

This study highlights the importance of measuring quality of life (QOL) in lung cancer treatment, as there are limited reports on this topic compared to other cancers.

The research utilized the Functional Living-Index-Cancer and Quality of Life Index tools in a randomized controlled trial of chemotherapy, emphasizing the need for standardized QOL assessment in lung cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer and quality of life. Thongprasert, S.[2019]

Patients with non-small-cell lung cancer (NSCLC) prioritize somatic quality of life (QOL) concerns over functional, emotional, and relational aspects when making decisions about life-extending therapies, with 84% indicating somatic issues as the most important factor.

Emotional well-being is closely linked to the experience of NSCLC symptoms, with 68% of patients viewing emotions as symptoms, highlighting the importance of emotional support and peer connections during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the experience of living with non-small-cell lung cancer (NSCLC): a qualitative study. Buzaglo, J., Gayer, C., Mallick, R., et al.[2022]

Recent advances in quality-of-life assessment methods for lung cancer patients include valid and reliable self-report questionnaires that are practical for clinical research, enhancing the evaluation of treatment impacts.

Quality-of-life measures have been applied in various lung cancer clinical trials, influencing treatment comparisons such as chemotherapy regimens and radiation doses, highlighting the importance of patient well-being alongside clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality-of-life and cost-effectiveness assessment in lung cancer. Bergman, B., Aaronson, NK.[2019]

The review identified over 150 studies on quality of life in lung cancer patients, highlighting the EORTC QLQ-LC13 questionnaire as the most reliable tool for measuring this aspect, emphasizing the need for regular assessments in clinical practice.

Improving quality of life in lung cancer patients is crucial, with a focus on symptom management, psychosocial support, and understanding patient concerns, suggesting that future treatments should prioritize quality of life alongside survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with lung cancer: a review of literature from 1970 to 1995. Montazeri, A., Gillis, CR., McEwen, J.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

An evidence-based determination of issues affecting quality of life and patient-reported outcomes in lung cancer: results of a survey of 660 patients. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Metrics to assess quality of life after management of early-stage lung cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Early-Stage Lung Cancer Patients' Perceptions of Presurgical Discussions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Survivor and Caregiver Expectations and Preferences Regarding Lung Cancer Treatment. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Quality-of-life assessment in cancer clinical trials: an intervention by itself? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Quality-of-life end points in cancer clinical trials: the U.S. Food and Drug Administration perspective. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

[Patient-Reported Outcome(PRO)to Measure Health-Related QOL in Lung Cancer Patients]. [2019]

10. Australia pubmed.ncbi.nlm.nih.gov

Lung cancer and quality of life. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Understanding the experience of living with non-small-cell lung cancer (NSCLC): a qualitative study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Quality-of-life and cost-effectiveness assessment in lung cancer. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Quality of life in patients with lung cancer: a review of literature from 1970 to 1995. [2019]