Quality of Life Intervention for Early-Stage Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Varies based on treatment modality

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how quality of life information can assist patients with early-stage lung cancer in making better treatment choices. It focuses on those deciding between surgery and a targeted radiation therapy called SBRT. The study seeks to reduce regret and improve satisfaction by providing a fact sheet about quality of life outcomes to one group, while the other group receives usual care. Patients who may qualify have stage I-II non-small cell lung cancer, are eligible for both surgery and SBRT, and can understand and discuss the information in English. As an unphased trial, this study offers patients the chance to contribute to research that could enhance decision-making for future patients.

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 prior data suggests that this quality of life intervention is safe for patients with early-stage lung cancer?

Research has shown that quality of life programs, like the one in this study, are generally safe. These programs aim to provide information to help participants make better treatment decisions. Unlike drugs or medical procedures, this type of program does not cause physical side effects. It serves as a helpful guide for decision-making. Because it is non-invasive, no negative effects have been reported. Participants in the study may receive information that boosts confidence in their treatment choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving the quality of life for early-stage lung cancer patients through a unique intervention. Unlike standard treatments like surgery or SBRT, which directly target the cancer, this approach uses a Quality of Life (QOL) fact sheet to support patients' well-being. This intervention aims to empower patients with information and support, allowing them to engage actively with their healthcare team and potentially enhance their overall treatment experience. The hope is that by addressing quality of life early on, patients may have better outcomes and satisfaction during their cancer journey.

What evidence suggests that this quality of life intervention is effective for early-stage lung cancer?

Research has shown that providing patients with information about their quality of life can help them make better treatment decisions. In this trial, participants in Group A will receive a Quality of Life (QOL) intervention fact sheet to review and discuss with their treating physician. Studies have found that patients with this information often feel more satisfied with their treatment choices, reducing regret later on. Although this approach does not directly treat lung cancer, it aids patients in deciding between surgery and a type of radiation therapy called SBRT. This support can lead to greater satisfaction with their care and possibly better long-term results. Participants in Group B will receive usual care without the QOL intervention. ^{1 2 4 5 6}

Who Is on the Research Team?

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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

I am a candidate for both surgery and SBRT.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Quality of Life 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.

How Is the Trial Designed?

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+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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) 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05292521

Quality of Life Intervention to Inform Patient Decision ... This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485735/

Survival and quality-of-life outcomes in early-stage NSCLC ... Conditional 5-year relative survival rates did not exceed 87%, indicating higher mortality in eNSCLC survivors. Lower conditional survival rates ...

3. withpower.com withpower.com/trial/phase-lung-neoplasms-3-2022-5af61

Quality of Life Intervention for Early-Stage Lung Cancer This trial studies how providing quality of life information affects decision-making in early-stage lung cancer patients choosing between surgery and ...

4. tandfonline.com tandfonline.com/doi/full/10.2217/lmt-2023-0003

Survival and Quality-of-life Outcomes in Early-Stage ... Another study found that 51.7% of patients with SPLC developed the condition within 5 years of initial treatment, falling to 34.5%, 5 to 10 years from initial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11496920/

Protocol for the Italian Lung Cancer Observational Study ... The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary ...

6. roswellpark.org roswellpark.org/clinical-trials/list/4838

Quality of Life Intervention to Inform Patient Decision- ... This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing ...