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Healthy Directions After Lung Surgery Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135211
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : July 2, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Massachusetts, Boston
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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.
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Directions After Lung Surgery Pilot
Official Title  ICMJE Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non Small Cell Lung
Intervention  ICMJE Behavioral: Lifestyle counseling
Study Arms  ICMJE 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.
Intervention: Behavioral: Lifestyle counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
72
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135211
Other Study ID Numbers  ICMJE 12-150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary E. Cooley, Phd, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • University of Massachusetts, Boston
Investigators  ICMJE
Principal Investigator: Mary E. Cooley, PhD, RN, FAAN Dana Farber Cancer Insitute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP