Healthy Directions After Lung Surgery Pilot

NCT ID: NCT02135211

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non Small Cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

Interventions

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Lifestyle counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* ≥ 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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mary E. Cooley, Phd

Nurse Scientist, PhD, CRNP, FAAN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary E. Cooley, PhD, RN, FAAN

Role: PRINCIPAL_INVESTIGATOR

Dana Farber Cancer Insitute

Locations

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Brigham & Woman's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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12-150

Identifier Type: -

Identifier Source: org_study_id

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