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Completed

NCT Number: NCT02135211

Healthy Directions After Lung Surgery Pilot

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.

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Key information

Conditions

Carcinoma, Non Small Cell Lung Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Health Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Risk Reduction Behavior Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Woman's Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle Counseling

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital
  • University of Massachusetts, Boston

Registry information

Official study title

Feasibility and Acceptability of a Lifestyle Intervention for Patients Receiving Surgical Treatment for Lung Surgery

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 9, 2014
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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