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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • 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.
Behavioral: Lifestyle counseling

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

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital
University of Massachusetts, Boston

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.

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