Healthy Directions After Lung Surgery Pilot

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02135211

Collaborator

Brigham and Women's Hospital (Other), University of Massachusetts, Boston (Other)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non Small Cell Lung	Behavioral: Lifestyle counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Lifestyle counseling

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Lifestyle counseling

Outcome Measures

Primary Outcome Measures

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 are enrollment rates.
Feasibility and acceptability [at end of study (4 months post intervention)]
The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials
Feasibility and acceptability [at end of study (4 months post intervention]
The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring
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

Interest for this study [baseline, 1 month, & 4 month]
The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
1. 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