CompletedPhase 1 / Phase 2NCT01786187

The Symptom Experience Study in Persons With Non-Small Cell Lung Cancer

Little is known about the symptom experience of persons having undergone surgery for lung cancer. What we do know is that symptoms are common and can become severe and lasting. The main purpose of this study is two-fold: 1. To better understand the symptom experience of persons with lung cancer prior to surgery and for up to six weeks after returning home from the hospital. 2. To examine the role of a light physical activity program in persons who are undergoing surgery for lung cancer for the treatment of a specific symptom. The goals of this study include: * Collecting information about the participant's current and prior health history, symptoms, and health-related quality of life. * Assessing our ability to recruit participants to the study. * Assessing participant's level of participation. * Evaluating the participant's satisfaction with the program. We expect that patients after undergoing surgery for lung cancer during the recovery process will experience multiple symptoms. We also expect to find that a light intensity physical activity program will be feasible, acceptable, and show a positive impact on symptoms such as cancer-related fatigue and confidence for cancer-related fatigue self-management. Information gained from this randomized controlled trial study will be used to refine the design of future larger-scale studies targeting symptoms such as cancer-related fatigue for the lung cancer population.

Checked against the public recordLast updated Feb 25, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations4
SponsorMichigan State University
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Michigan State University
Interventions being studied
Behavioral: Light Physical Activity; Other: Symptom Experience Report
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. Women and men at least 21 years of age with suspected NSCLC to be confirmed after surgery. 2. Planned surgical resection, not diagnostics alone, for treatment of suspected non-small cell lung cancer (NSCLC) to include such surgical approaches as open thoracotomy, video assisted thoracic surgery (VATS), and Robotic procedures. 3. Karnofsky Performance Status score of at least 70%. 4. Thoracic surgeon approval pre- and post-surgery. 5. Medically stable co-morbid conditions including cardiovascular disease such as post-myocardial infarction, stable coronary bypass graft surgery, and stable percutaneous transluminal coronary angioplasty; and mild to moderate cardiopulmonary obstructive disease. 6. Has phone access capability. 7. Able to speak and write English. 8. Able to hear and speak for phone interviews. 9. Owns a television. 10. Lives within 1.5 hours driving distance of recruitment site. Exclusion Criteria: 1. Severe impairment in seeing, hearing, and speaking. 2. Uncontrolled co-morbid conditions such as cardiac or pulmonary disease. 3. Uncontrolled hypertension. 4. Active treatment for malignancy within the past six months (other than non-melanoma skin cancer and when undergoing long-term hormonal treatment for common cancers such as breast and prostate cancer where disease is stable). 5. Presence of metastatic disease. 6. Requires portable oxygen therapy for activities of daily living. 7. Weight greater than 330 pounds (weight capacity of the Wii balance board). 8. History of photosensitive seizures. 9. Any condition or disorder that would impede safe participation as directed. 10. Plans to relocate outside the study area during the study period or unable to fully participate. 11. Diagnosed dementia. 12. Video-assisted thoracic surgery (VATS) procedure.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Michigan State UniversityEast Lansing, Michigan
  • Sparrow HospitalEast Lansing, Michigan
  • West Michigan Cardiothoracic SurgeonsGrand Rapids, Michigan
  • McLaren Greater Lansing, Greenlawn CampusLansing, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 25, 2019. Always confirm current availability with the study team.

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