Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Michigan State University
- Enrollment
- 87
- Locations
- 4
- Primary Endpoint
- Feasibility as Measured by Retention.
Study Overview
Brief Summary
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:
- 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.
- 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.
Detailed Description
Study Procedures:
Participants will be randomly assigned (like flipping a coin) to one of the following groups upon completion of collection of initial information about the participant's: current and prior health history, symptoms, and health-related quality of life, and take a 6-minute self-paced walking test to measure walking ability. This test will occur at Spectrum Health facility before surgery.
Groups: 1) The Symptom Experience Group and the 2) Light Physical Activity Group
Description of the Symptom Experience Group:
In addition to receiving conventional treatment for your cancer, as prescribed by your health care providers, you will receive planned, structured, weekly telephone visits to report the experience of your symptoms and health-related quality of life questions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women and men at least 21 years of age with suspected NSCLC to be confirmed after surgery.
- •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.
- •Karnofsky Performance Status score of at least 70%.
- •Thoracic surgeon approval pre- and post-surgery.
- •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.
- •Has phone access capability.
- •Able to speak and write English.
- •Able to hear and speak for phone interviews.
- •Owns a television.
- •Lives within 1.5 hours driving distance of recruitment site.
Exclusion Criteria
- •Severe impairment in seeing, hearing, and speaking.
- •Uncontrolled co-morbid conditions such as cardiac or pulmonary disease.
- •Uncontrolled hypertension.
- •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).
- •Presence of metastatic disease.
- •Requires portable oxygen therapy for activities of daily living.
- •Weight greater than 330 pounds (weight capacity of the Wii balance board).
- •History of photosensitive seizures.
- •Any condition or disorder that would impede safe participation as directed.
- •Plans to relocate outside the study area during the study period or unable to fully participate.
- •Diagnosed dementia.
- •Video-assisted thoracic surgery (VATS) procedure.
Arms & Interventions
Symptom Experience Group
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
Intervention: Symptom Experience Report (Other)
Light Physical Activity Group
Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
Intervention: Light Physical Activity (Behavioral)
Outcomes
Primary Outcomes
Feasibility as Measured by Retention.
Time Frame: 6-weeks.
Retention is the percentage of those enrolled and completed and finished the program.
Feasibility as Measured by Adverse Events.
Time Frame: 6-weeks.
Adverse Events is the percentage of participant's who had an adverse event.
Determine Feasibility as Measured by Rates of Recruitment.
Time Frame: At the beginning of the study.
Rates of recruitment were measured by the percentage of those eligible who enrolled.
Feasibility as Measured by Adherence.
Time Frame: 6-weeks.
Adherence is the percentage of those adhering to the recommended exercise.
Secondary Outcomes
- Cancer-Related Fatigue Severity(At six weeks after discharge from the hospital after surgery for lung cancer.)
Investigators
Amy Jude Hoffman, RN, PhD
Assistant Professor
Michigan State University