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About
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:
The goals of this study include:
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.
Full 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.
In the Symptom Experience Group you will:
If you wish to take part in this study you will need to:
In the Symptom Experience Group you will receive:
Description of the Light Physical Activity Group:
In addition to receiving conventional treatment for cancer, as prescribed by your health care providers, you will receive a home-based light physical activity program to help you manage a specific symptom related to cancer and cancer treatment.
In the Light Physical Activity Group you will:
Provide information about your current and prior health history.
Take a 6-minute self-paced walking test to measure your walking ability at a Spectrum Health facility before surgery and at approximately 6-weeks after returning home from the hospital (prior to possible chemotherapy and/or radiation therapy).
Participate in a self-scheduled, home-based physical activity program to help you learn how to manage a specific symptom related to cancer and cancer treatment for a total of six weeks following your return home from the hospital.
Participate in a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as able by week 6.
Wear a pedometer each day of the study and record the number of steps you take each day.
Record information and comments in a daily diary (takes approximately 2 minutes to complete each day) and answer research questions via a weekly telephone visit throughout the study.
Contact the nurse researcher if you have any study related questions. If you wish to take part in this study you will need to:
In the Light Physical Activity Group you will receive:
Program education prior to surgery.
A telephone visit from a nurse within 3 days (24 hours is optimum) after being discharged from the hospital to:
Ask questions about your symptoms to see if you are ready to start light physical activity program taking approximately 5 minutes.
A telephone visit from a research assistant within 3 days (24 hours is optimum) after being discharged from the hospital to:
The first home visit from the nurse after surgery will take approximately 2 hours and the nurse will:
At the beginning of week two, the nurse will make one more home visit, and at the beginning of weeks 3-6 the nurse will make a telephone visit to collect and review your recorded information.
The nurse will be available to make additional home and telephone visits should you need assistance.
At the end of weeks 1-6, research staff will make a telephone visit to complete the health questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking approximately 30 minutes.
We expect 86 persons, 21 years of age or older who are scheduled for surgery to treat lung cancer from the west Michigan area to participate in the study.
The potential risks for the Symptom Experience and Light Physical Activity Groups Include:
Risks associated with the six-minute walk test are considered low. The study may involve risks to you which are currently unknown or unforeseeable. Risks may include and are not limited to:
The potential risks of this study for the Light Physical activity Group Include:
The light physical activity program as prescribed in this study corresponds to normal every day activities that are mildly exerting and pose no greater challenge than normal activities of daily living such as:
The reaction to the body to physical activity cannot always be predicted with accuracy and there is a risk of falling while walking and/or standing in place.
As part of the program involves the use of your television, some people (1 in 4,000) may have seizures or blackouts triggered by light flashes or patterns while they are watching television or playing such things as video games even if they haven't had a seizure before.
The reaction of the body to physical activity cannot always be predicted with accuracy so safety procedures are being provided to each participant prior to participation. Safety procedures include but are not limited to:
Potential Benefits of the Study:
We cannot promise any benefits to you or others from your taking part in this research. It is hoped that what is learned in this study may benefit other lung cancer patients in the future. If you agree to take part in this study you will receive results of this study in the future following study completion. We will notify you if any significant new findings develop during the course of the study which might affect your willingness to participate.
The potential benefits of being in the Light Physical Activity Group may include:
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87 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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