NCT00717795

Brief Summary

The purpose of this study is to learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 10, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

15 years

First QC Date

July 16, 2008

Last Update Submit

June 6, 2023

Conditions

Keywords

SurvivorPhysical ActivityNED08-067

Outcome Measures

Primary Outcomes (1)

  • To evaluate the feasibility (acceptability, adherence, treatment integrity, retention, participant satisfaction) of implementing a physical activity intervention trial among sedentary and insufficiently active lung cancer survivors.

    conclusion of the study

Secondary Outcomes (2)

  • Obtain preliminary data on effect of a physical activity intervention on functional ability, health-related QOL, dyspnea, fatigue, balance, strength & self-report physical activity among sedentary and insufficiently active lung cancer survivors

    conclusion of the study

  • To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout.

    conclusion of the study

Study Arms (2)

1

Arm 1 - Physical Activity intervention

Behavioral: interview and physical activity

2

Arm 2 - Wait-list control

Behavioral: interview and wait list

Interventions

For Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline).

1

Participants in the control condition (Arm 2)will be assessed at baseline and 12 weeks post baseline (Follow-up). At this time, the PA intervention will be offered at no cost to the participants in the control condition. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In total, we will recruit and enroll a random sample of 70 lung cancer survivors who are at least one year post thoracic surgical resection and have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any adjuvant treatment.

You may qualify if:

  • Diagnosis and treatment at MSKCC of primary NSCLC; and/or pulmonary carcinoid;
  • At least one year post thoracic surgical resection;
  • Have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any cancer treatment;
  • Currently sedentary or insufficiently active, defined by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention as less than a total of 150 minutes of at least moderate intensity PA per week;
  • Able to complete a six-minute walk test (6MWT);
  • Able to provide informed consent.
  • FOCUS GROUP ONLY:
  • Completed the Physical Activity program offered through this study (08067);

You may not qualify if:

  • Presence of one of the following medical factors at screening:
  • regular use of an ambulatory aid (cane or walker);
  • resting oxygen saturation less than 88%;
  • inability to walk due to severe arthritis or other musculoskeletal problems;
  • a diagnosis of unstable angina in the previous 6 weeks;
  • a heart attack, angioplasty or heart surgery in the previous 3 months;
  • current heart rate \<50 or \>120 at rest; current uncontrolled hypertension;
  • current significant valvular heart disease or decompensated congestive heart failure and
  • patient reported pain of any origin that would preclude participation in the proposed PA intervention
  • Evidence of significant medical cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention
  • Self-reporting of greater than 60 minutes of vigorous activity per week or 150 minutes of moderate intensity PA per week.
  • Patient resides at more than two hours travel distance from the Center
  • Insufficient English fluency to complete evaluation tools.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Interventions

Interviews as TopicExerciseWaiting Lists

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Jamie Ostroff, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 18, 2008

Study Start

June 10, 2008

Primary Completion

June 5, 2023

Study Completion

June 5, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations