Healthy Directions After Lung Surgery Pilot

Carcinoma, Non Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135211
• Other study ID #: 12-150
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Behavioral:
• Lifestyle counseling

Locations

Country	Name	City	State
United States	Brigham & Woman's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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	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
Secondary	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