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Healthy Directions After Lung Surgery Pilot

Primary Purpose

Carcinoma, Non Small Cell Lung

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non Small Cell Lung focused on measuring non-small cell lung cancer (NSCLC), multiple risk factor, lifestyle intervention, health behavior, lifestyle risk reduction, health related quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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)

Sites / Locations

  • Brigham & Woman's Hospital
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials
Feasibility and acceptability
The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring
Feasibility and acceptability
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
The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life.
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.

Full Information

First Posted
May 6, 2014
Last Updated
June 28, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, University of Massachusetts, Boston
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1. Study Identification

Unique Protocol Identification Number
NCT02135211
Brief Title
Healthy Directions After Lung Surgery Pilot
Official Title
Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, University of Massachusetts, Boston

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non Small Cell Lung
Keywords
non-small cell lung cancer (NSCLC), multiple risk factor, lifestyle intervention, health behavior, lifestyle risk reduction, health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Primary Outcome Measure Information:
Title
Feasibility and acceptability
Description
The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.
Time Frame
at end of study (4 months post intervention)
Title
Feasibility and acceptability
Description
The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials
Time Frame
at end of study (4 months post intervention)
Title
Feasibility and acceptability
Description
The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring
Time Frame
at end of study (4 months post intervention
Title
Feasibility and acceptability
Description
The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.
Time Frame
at end of study (4 months post intervention)
Secondary Outcome Measure Information:
Title
Interest for this study
Description
The secondary outcome measures of interest for this study are lifestyle risk reduction and Health Related-Quality of Life.
Time Frame
baseline, 1 month, & 4 month
Title
Interest for this study
Description
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.
Time Frame
baseline, 1 month, & 4 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E. Cooley, PhD, RN, FAAN
Organizational Affiliation
Dana Farber Cancer Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Woman's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Healthy Directions After Lung Surgery Pilot

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