NCT02135211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

May 6, 2014

Last Update Submit

June 28, 2018

Conditions

Carcinoma, Non Small Cell Lung

Keywords

non-small cell lung cancer (NSCLC)multiple risk factorlifestyle interventionhealth behaviorlifestyle risk reductionhealth related quality of life

Outcome Measures

Primary Outcomes (4)

  • Feasibility and acceptability

    The primary outcome measures to establish feasibility and acceptability of the intervention for this study are enrollment rates.

    at end of study (4 months post intervention)

  • Feasibility and acceptability

    The primary outcome measures to establish feasibility and acceptability patient's use of intervention materials

    at end of study (4 months post intervention)

  • Feasibility and acceptability

    The primary outcome measures to establish feasibility and acceptability of the completion of self-monitoring

    at end of study (4 months post intervention

  • Feasibility and acceptability

    The primary outcome measures to establish feasibility and acceptability of the intervention for this study completion of nurse-patient contacts.

    at end of study (4 months post intervention)

Secondary Outcomes (2)

  • Interest for this study

    baseline, 1 month, & 4 month

  • Interest for this study

    baseline, 1 month, & 4 month

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

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

Interventions

Lifestyle counselingBEHAVIORAL
Lifestyle counseling

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 21 years of age
  • English speaking
  • MD approval to participate in study
  • \. a histological diagnosis of NSCLC undergoing potentially curative treatment
  • \. OR those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham & Woman's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungHealth BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Mary E. Cooley, PhD, RN, FAAN

    Dana Farber Cancer Insitute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Scientist, PhD, CRNP, FAAN

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 9, 2014

Study Start

September 1, 2012

Primary Completion

October 1, 2014

Study Completion

June 1, 2015

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

US(2)