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

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05292521
Collaborator
National Comprehensive Cancer Network (Other)
150
1
2
12
12.5

Study Details

Study Description

Brief Summary

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 standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.

Detailed Description

PRIMARY OBJECTIVE:
  1. Determine the effect of provision of quality-of-life (QOL) information versus usual care for standard of care surgery or SBRT treatment on decision regret.
SECONDARY OBJECTIVES:
  1. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.

  2. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.

OUTLINE: Patients are randomized to 1 of 2 groups.

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

Patients are followed up at 1, 3, and 6 months after standard of care surgery or SBRT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (QOL fact sheet)

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).

Other: Informational Intervention
Receive QOL fact sheet

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group B (usual care)

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

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Decision regret [At 6 months]

      Compare the extent of decision regret based on Decision Regret Scale between the provision of quality of life (QOL) information versus usual care for standard of care surgery or stereotactic body radiation therapy (SBRT) treatment. The five-point decision regret score will be converted to a 100-point score as described by others, where a higher score reflects an increased decision regret. In this schema, a decision regret score > 25 % is deemed moderate to severe regret. The dichotomized decision regret will be modeled as a function of group, time, and their interaction using a generalized estimating equations (GEE) logistic regression model with an autoregressive covariance structure. The rates of less than moderate to severe regret will be compared between groups at 6-months using a one-sided test about the appropriate contrast of model estimates.

    Secondary Outcome Measures

    1. Quality of Life (EORTC QLQ-C30) [Up to 6 months]

      Will compare QOL measures based on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment.

    2. Quality of Life (QOL) [Up to 6 months]

      Will compare QOL measures based on the lung cancer- specific questionnaire (EORTC QLQ-LC13) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment.

    3. Difference in consideration of regret [Up to 6 months]

      Compare decisions about treatment for early stage lung cancer and examined whether regret is a consideration in treatment decisions between those who received the quality of life fact sheet and those who did not.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age >= 18 years of age

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

    • Eligible for both surgery and SBRT

    • Able to provide informed consent in English

    • Have verbal fluency in English

    • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

    Exclusion Criteria:
    • Diagnosed with stage III-IV NSCLC

    • Eligible for either only surgery or SBRT, but not both

    • Eligible for palliative-intent treatments or supportive care only.

    • Pregnant female participants.

    • Unwilling or unable to follow protocol requirements

    • Any condition which in the investigator's opinion deems the participant an unsuitable candidate

    • Cognitively impaired adults/adults with impaired decision-making capacity

    • Individuals who are not yet adults (infants, children, teenagers)

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Cancer Institute Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute
    • National Comprehensive Cancer Network

    Investigators

    • Principal Investigator: Anurag K Singh, Roswell Park Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05292521
    Other Study ID Numbers:
    • I 2220321
    • NCI-2022-01257
    • I 2220321
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022