Healthy Directions After Lung Surgery Pilot

Not Applicable

Completed

• Conditions: Carcinoma, Non Small Cell Lung
• Interventions: Behavioral: Lifestyle counseling

• Registration Number: NCT02135211
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Primary Completion: 2014-10
• Study Completion: 2015-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle counseling	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.

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability	at end of study (4 months post intervention)	The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.

Secondary Outcome Measures

Name	Time	Method
Interest for this study	baseline, 1 month, & 4 month	The secondary outcome measures of interest for this study is an interview to evaluate the intervention will be conducted with the participant and the partner at the conclusion of the study.

Trial Locations

Locations (2)

Brigham & Woman's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States