Overview

This trial is active, not recruiting.

Condition carcinoma, non small cell lung
Treatment lifestyle counseling
Phase phase 0
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date September 2012
End date October 2014
Trial size 72 participants
Trial identifier NCT02135211, 12-150

Summary

The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is a single arm, quasi-experimental, pre- and post- test study design to test the feasibility and acceptability of a multiple risk factor, lifestyle intervention in patients receiving surgical treatment for lung cancer or those suspected of having lung cancer.
lifestyle counseling

Primary Outcomes

Measure
Feasibility and acceptability
time frame: at end of study (4 months post intervention)
Feasibility and acceptability
time frame: at end of study (4 months post intervention)
Feasibility and acceptability
time frame: at end of study (4 months post intervention
Feasibility and acceptability
time frame: at end of study (4 months post intervention)

Secondary Outcomes

Measure
Interest for this study
time frame: baseline, 1 month, & 4 month
Interest for this study
time frame: baseline, 1 month, & 4 month

Eligibility Criteria

Male or female participants at least 21 years old.

Patient Inclusion Criteria: - > 21 years of age - English speaking - MD approval to participate in study - Meets one of the inclusions below: - 1. a histological diagnosis of NSCLC undergoing potentially curative treatment - 2. OR those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules - 3.OR patients who have had a surgical procedure for lung cancer within the last six months. - May invite a buddy to join study with them defined as a friend, partner, adult child or sibling Buddy Inclusion Criteria: - ≥ 21 years of age, - English speaking, who is invited by the subject to join as a support person (e.g., friend, partner, adult child or sibling)

Additional Information

Official title Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
Principal investigator Mary E. Cooley, PhD, RN, FAAN
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.