Carcinoma, Non Small Cell Lung Clinical Trial
Official title:
Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
NCT number | NCT02135211 |
Other study ID # | 12-150 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | June 2015 |
Verified date | June 2018 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Woman's Hospital | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Brigham and Women's Hospital, University of Massachusetts, Boston |
United States,
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 |
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