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Clinical Trials/NCT05087251
NCT05087251
Active, Not Recruiting
N/A

Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent

Massachusetts General Hospital2 sites in 1 country100 target enrollmentSeptember 30, 2021
ConditionsLung Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Massachusetts General Hospital
Enrollment
100
Locations
2
Primary Endpoint
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
Status
Active, Not Recruiting
Last Updated
last month

Overview

Brief Summary

The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.

Detailed Description

This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance. In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program. It is expected that about 100 people will take part in this research study. The American Lung Association is supporting this research by providing funding for the research study.

Registry
clinicaltrials.gov
Start Date
September 30, 2021
End Date
June 30, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lara Traeger

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 21 or older
  • Able to read and respond in English
  • Diagnosis of non-small cell lung cancer or small cell lung cancer
  • Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
  • Completed cancer treatment within past 3 weeks
  • If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete
  • If final treatment is surgery: within 3 weeks after hospital discharge following surgery

Exclusion Criteria

  • Comorbid health condition that would interfere with study participation
  • Current participation in cognitive behavioral therapy treatment

Outcomes

Primary Outcomes

Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer

Time Frame: Up to 12 weeks

We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)

Secondary Outcomes

  • Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7(Up to 12 weeks)
  • Symptom burden: Edmonton Symptom Assessment Scale(Up to 12 weeks)
  • Psychological symptom burden: Hospital Anxiety and Depression Scale(Up to 12 weeks)
  • Social support: Multidimensional Scale of Perceived Social Support(Up to 12 weeks)
  • Social isolaton: Campaign to End Loneliness Measurement Tool(Up to 12 weeks)

Study Sites (2)

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