Healthy Directions After Lung Surgery Pilot
June 28, 2018 updated by: Mary E. Cooley, Phd, Dana-Farber Cancer Institute
Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, United States, 02115
- Brigham & Woman's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and acceptability
Time Frame: 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.
|
at end of study (4 months post intervention)
|
|
Feasibility and acceptability
Time Frame: at end of study (4 months post intervention)
|
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
Time Frame: at end of study (4 months post intervention
|
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
Time Frame: 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.
|
at end of study (4 months post intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interest for this study
Time Frame: baseline, 1 month, & 4 month
|
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
Time Frame: 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.
|
baseline, 1 month, & 4 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary E. Cooley, PhD, RN, FAAN, Dana Farber Cancer Insitute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2012
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
May 7, 2014
First Posted (Estimate)
May 9, 2014
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.