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Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience


Phase 1/Phase 2
21 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience


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:

- Provide information about your current and prior health history.

- Take a 6-minute self-paced walking test to measure your walking ability at Spectrum
Health facility before surgery and at approximately 6-weeks after returning home from
the hospital (prior to possible chemotherapy and/or radiation therapy).

- Wear a pedometer each day of the study and record the number of steps you take each
day.

- Contact the nurse researcher if you have any study related questions.

- 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.

If you wish to take part in this study you will need to:

- Keep your study appointments.

- Tell your telephone research assistant about any medications you are taking.

- Tell your telephone research assistant about any side effects, doctor visits, or
hospitalizations that you may have whether or not you think they are related to the
study.

In the Symptom Experience Group you will receive:

- Program education prior to surgery.

- A telephone visit within 3 days (24 hours is optimum) after being discharged from the
hospital to ask questions about your health with the interview taking approximately 30
minutes.

- The health interview can be rescheduled for completion within 3 days of hospital
discharge should you not feel well enough to complete the interview.

- At the end of weeks 1-6, we will make a telephone visit to complete health
questionnaires with most interviews taking 15 minutes except on weeks 3 and 6 taking
approximately 30 minutes.

- Upon completion of your participation in the Symptom Experience Group, you will receive
information regarding the light physical activity program.

- Upon completion of the study, you will be provided an overview of the results of the
study.

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:

- Keep your study appointments.

- Tell your nurse about any medications you are taking.

- Tell your nurse about any side effects, doctor visits, or hospitalizations that
you may have whether or not you think they are related to the study.

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.

- If you are ready, we will arrange a home visit within 4 days of discharge.

- If not ready, we will contact your surgeon to help you and call you each day to
assess if you are ready to start.

- A telephone visit from a research assistant within 3 days (24 hours is optimum) after
being discharged from the hospital to:

- Ask questions about your health with the interview taking approximately 30
minutes.

- The health interview can be rescheduled for completion within 3 days of hospital
discharge should you not feel well enough to complete the interview.

- The first home visit from the nurse after surgery will take approximately 2 hours and
the nurse will:

- Assemble and teach you how to operate the physical activity equipment.

- Assist you in completing your first physical activity on this day.

- Follow-up your first home visit with a telephone visit within 24 hours to answer
any questions and concerns about the program.

- 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:

- You may stumble or fall, get short of breath, experience muscle cramps, nausea, chest
pain, and abnormal blood pressure.

- The walk test is self-paced by the participant for six-minutes and will be stopped if
you want it to be stopped.

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:

- Strolling slowly in your home or at work. Grocery shopping.

- Performing light work in the house such as making a bed, washing dishes, preparing
food, dusting, and carrying out the trash.

- Riding a lawn mower to mow the lawn or walking applying seed or fertilizer to the
lawn.

- Walking in the mall; Bird watching.

- The development or increase of activity-dependent symptoms such as fatigue or
muscle or joint soreness.

- 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:

- Following your physical activity prescription and safety procedures.

- Using tools to monitor your heart rate such as through a heart rate wristwatch
monitor.

- Telephone access available during light physical activity.

- Accessing your nurse researchers if you have a concern.

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:

- Increased ability to manage a symptom related to cancer and its treatment.

- Increased ability in performing day-to-day activities.

- Increased heart and lung (cardiorespiratory) fitness.

- Receiving symptom management help from professional registered nurses.

- Feeling more in control of your symptoms.

Are there any costs and compensations for being in the study? Neither you nor your insurance
company will be billed for your participation in the study. You will receive a potential
$100.00 in gift cards in appreciation for your time and willingness to share your
experiences and to compensate you for your travel. You will be given a $50.00 gift card
following completion of the initial six-minute walk test, and a $50.00 gift card upon the
completion of the study including the second six-minute walk test, and return of the
physical activity equipment. In addition, all participants will keep their pedometers upon
completion of the study.


Inclusion Criteria:



1. Women and men at least 21 years of age with suspected NSCLC to be confirmed after
surgery.

2. Planned surgery for suspected NSCLC.

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).

5. Presence of metastatic disease.

6. Requires portable oxygen therapy for activities of daily living.

7. Weight greater than 300 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Determine Feasibility and Acceptability

Outcome Description:

Determine feasibility and acceptability by a) analyzing rates of recruitment, adherence, and retention; b) monitoring adverse events; c) identifying facilitators and barriers to recruitment, adherence, and retention.

Outcome Time Frame:

Six weeks after discharge from the hosptial after surgery for lung cancer.

Safety Issue:

Yes

Principal Investigator

Amy J Hoffman, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michigan State University

Authority:

United States: Institutional Review Board

Study ID:

R21CA164515

NCT ID:

NCT01786187

Start Date:

January 2013

Completion Date:

August 2014

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Symptoms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Michigan State UniversityEast Lansing, Michigan  48824
Spectrum HealthGrand Rapids, Michigan  49503