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Healthy Directions After Lung Surgery Pilot

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ClinicalTrials.gov Identifier: NCT02135211
Recruitment Status : Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Massachusetts, Boston
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non Small Cell Lung Behavioral: Lifestyle counseling Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
Study Start Date : September 2012
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : November 2016

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



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135211


Locations
United States, Massachusetts
Brigham & Woman's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
University of Massachusetts, Boston
Investigators
Principal Investigator: Mary E. Cooley, PhD, RN, FAAN Dana Farber Cancer Insitute

Responsible Party: Mary E. Cooley, Phd, Nurse Scientist, PhD, CRNP, FAAN, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02135211     History of Changes
Other Study ID Numbers: 12-150
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Mary E. Cooley, Phd, Dana-Farber Cancer Institute:
non-small cell lung cancer (NSCLC)
multiple risk factor
lifestyle intervention
health behavior
lifestyle risk reduction
health related quality of life

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases