Healthy Directions After Lung Surgery Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery

Conditions
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Carcinoma, Non Small Cell Lung

Intervention / Treatment
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* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>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. | Behavioral: Lifestyle counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability | The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates. | at end of study (4 months post intervention) | 
| Feasibility and acceptability | The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials | at end of study (4 months post intervention) | 
| Feasibility and acceptability | The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring | at end of study (4 months post intervention | 
| Feasibility and acceptability | The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts. | at end of study (4 months post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest for this study | The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life. | baseline, 1 month, & 4 month | 
| Interest for this study | 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. | baseline, 1 month, & 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer (NSCLC), multiple risk factor, lifestyle intervention, health behavior, lifestyle risk reduction, health related quality of life