Ms. Vickie L. Venne Grant Chair, Salt Lake City Race for the Cure Susan G. Komen foundation UUHSC SOM 2C123 50 North Medical Drive Salt Lake City, UT 84112 Dear Mrs. Venne, Please find enclosed a brief five-page proposal seeking funds for the cost of oncology

rehabilitation research at the University of Utah Health Sciences Center. This is a collaborative

effort designed to help restore cancer patients to their fullest attainable physical, social and

vocational capability.

Oncology rehabilitation closely follows the guidelines set forth by cardiac and pulmonary

rehabilitation. As such, one may see cancer rehabilitation patients realizing similar outcomes.

Typical economic outcomes from cardiopulmonary rehabilitation are: fewer emergency room

visits, lower re hospitalization rates, decreased treatment interventions, and decreased duration

per hospitalization. Program graduates typically return to work sooner and remain actively

employed longer.

We appreciate the time you spend reviewing this proposal seeking funds for cancer rehabilitation

research. We would be delighted to answer any questions.

Sincerely,

Roger K. Campbell, M.S., CET, MFT-c

Cancer Research Project Manager

Research cost for one Exercise Treatment Subject in Oncology Rehabilitation

Rehabilitation orientation (90 minutes) = $ 142.30

Twenty Four (24) phase II exercise sessions = $ 1,147.20

Two (2) Cardiopulmonary diagnostic exercise test = $ 437.80

Cost for One Exercise Treatment Subject = $1,727.30

Brief explanation of the cancer research project.

The aims of this program are to provide 24-structured exercise sessions two times a week for

three months. This is an exercise and health promotion research project for breast cancer patients

who have been recently diagnosed. Patients will be oriented to the program, supervised during

exercise, receive instructions on developing increased functional ability and learn health-

promoting habits (e.g. diet, stress reduction, smoking cessation). The long-term goal of the

cancer rehabilitation project is to improve quality of well-being by maintaining functional ability,

productivity and independence.

This investigation is a collaborative effort of a multidisciplinary team that includes oncology,

pulmonology, nursing and exercise physiology. The study will use a phases II approach similar to

the pulmonary rehabilitation model, that is, patients will receive close monitoring and training.

All patients will undergo cardiopulmonary diagnostic exercise testing at entry and exit from the

program. This test provides information for the exercise prescription and will also contribute

objective physiologic outcome data for each program and non-program participant. The research

project will be conducted within the Pulmonary Rehabilitation program on the fourth floor of the

University Hospital. This area was selected because of the proximity to the physicians and

availability of exercise equipment. The individualized exercise sessions are supervised my

Masters prepared exercise physiologist who are certified in advancer cardiac life support

(ACLS).

It has been reported that structured exercise programs for previously sedentary cancer patients

is safe. Furthermore, patients who are receiving chemotherapy exhibit a training effect in

addition to positive physical and psychological effects. This program is expected to demonstrate

the same positive short-term effects and prevent some of the long-term complications of cancer

treatment. In the short term, patients who exercise, will improve functional ability, reduce pain

and fatigue and improve mood and quality of life. Long term benefits may include: decreased risk

for coronary artery disease, prevention of osteoporosis, improved weight control, increased

productivity, improved independence and improved quality of life. Although there is an initial

cost for each patient who receives the exercise treatment program which ($1727.20 inclusive of

all exercise sessions and diagnostic testing) the long term savings may be realized by reduced

clinic visits, hospitalization, and reduced risk for co morbidities.

Statement of need and problem to be addressed.

It is estimated that 1,382,400 new cases of invasive cancer will be diagnosed in the United

States in 1997 (Paker, Tong, Bolden, & Wingo, 1997). In 1990, the National cancer Institute

reported the overall cost of cancer to be $104 billion; including $35 billion in direct medical

costs, $12 million in lost productivity, and $57 billion in morbidity expenses. This accounts for

10% of the total costs of disease in the United States (American Cancer Society, 1991). As

medical technology has become more sophisticated, treatment protocols have become more

rigorous and the ability to manage life threatening treatment-related infection has improved.

However, these advances have not coincided with improvements in the management of treatment

related side effects, which are often worse than the cancer treatment itself. The combination of

fatigue, weakness, physical decline and debilitation are common and well-documented side

effects of cancer treatment that affects a patient’s quality of life during and after treatment, and

results in a loss of productivity.

Cancer rehabilitation has been demonstrated to increase functional capacity and improve

quality of life. Declines in functional ability can be minimized through the institution of an

exercise program. Aerobic exercise interventions have been tested in women with breast cancer

receiving adjuvant chemotherapy, radiation therapy and after autologous peripheral stem cell

transplantation. All have been shown to be feasible and effective (Dimeo, 1997; MacVicar &

Winningham, 1987; MacVicar, Winningham, & Nickel, 1989; Mock, 1994; 1997; Schwarts,

1997). The benefits of both aerobic and resistance exercise are well-documented in the general

population, and a growing body of evidence suggests that aerobic exercise may prevent reduced

functional capacity, nausea, fatigue, pain, low self-esteem and other quality of life issues that

confront cancer patients (Dimeo, 1997; Johnson & Kelly, 1990; MacVicar & Winningham, 1987;

MacVicar, Winningham, & Sexton, 1991). Dimeo (1997) concluded that activity, not rest, should

be encouraged to reduce fatigue and that exercise helped subjects recover normal function more

quickly after transplant including experiencing a shorter nadir period and less transfusion

dependency and requiring less pain medication. Subjects who participated in an 8-week exercise

program demonstrated improved functional ability (mean increase of 10% in functional ability

compared to a decline of 16% in non exercisers), less severe side effects, and did not gain weight

(Schwartz, 1997). Further research is warranted in the quality of well-being category. This type

of research is needed so that cost utility models and resource allocation strategies may be

identified, measured, described and implemented. This research information may aid policy

makers in the insurance and hospital setting in determining the need and effectiveness of

developing oncology rehabilitation services.

Description of constituency to be served and how they will benefit.

Subject selection and inclusion into oncology rehabilitation is based on the following: Newly

diagnosed breast cancer patients who have not started chemotherapy or radiation therapy. This

subject selection criterion delivers the greatest opportunity for maintaining the quality of well-

being, productivity, self-esteem, personal control, and independence of the patient. Setting this

starting point for oncology rehabilitation allows the exercise treatment to intervene and

significantly reduce the debilitation that occurs due to the side-effects from chemotherapy and

radiation therapy. As described by Dimeo (1997) Subjects who participated in an exercise

program demonstrated improved functional ability (mean increase of 10% compared to a decline

of 16% in non exercisers), less severe side effects, and did not gain weight (Schwartz, 1997).

The first program goal is to enroll six (6) newly diagnosed breast cancer patients who have not

received chemotherapy or radiation therapy into oncology rehabilitation. Second Goal, We will

perform pre and post program cardiopulmonary diagnostic exercise testing on 12 program

participants, six (6) exercise treatment subjects and six (6) control subjects. This test will provide

objective numeric data, which defines functional ability, exercise prescription and program

outcomes. Third Goal, patients will fill out a pre and post program Quality of well-being scale.

The Quality of well-being scale is a preference-weighted measure that produces a point-in-time

expression of well-being that runs from 0 (for death) to 1.0 (for asymptotic full function). The

measure is used for cost / utility analysis and as an outcome measure in clinical trials. This

instrument is also used as a resource allocation model. Fourth Goal, each exercise participant will

be guided and trained through 24 session of structured exercise designed to increase their

functional status.

This pilot study is structured to serve six (6) exercise treatment subjects and six (6) control

subjects. The control subjects will receive a pre and post cardiopulmonary diagnostic exercise

test. They will not be discouraged to exercise. However they will not receive structured exercise

guidance and training. 12 subjects will be chosen by initial diagnosis, then randomly assigned to

the exercise treatment group and the control group.

Description of activities planned to accomplish these goals.

Is this a new or ongoing activity of the hospital .

Program participants will be trained to participate in the following activities: Aerobic exercise

such as tread mill walking, recumbent stationary cycling (well tolerated seat), recumbent stair

stepping, upright stair stepping, and a multi station strength training system. Education sessions

will accompany exercise sessions; these lesions are designed to develop health-promoting habits

(e.g. diet, stress reduction, smoking cessation).

We will progress the patient in an incremental fashion, which is designed to increase functional

ability. Each session will be recorded in a database with recommendations for progression.

Oncology rehabilitation is a new service and research endeavor at the University of Utah

Health Science Center / Pulmonary - Oncology Rehabilitation Program. We have worked with

four cancer patients this year. As a result of our experience, we have developed guidelines and

skills specifically related to improving the functional ability of several cancer patients. These

experiences have impressed upon us the need and appropriateness of developing rehabilitation

services for cancer patients.

Timetable for accomplishing goals

All research objectives will be accomplished within one year from the date of funding. This

includes a report of finding in final form.

Description of other organizations / entities participating in the program.

Dr. Saundra S. Buys, M.D. is our primary supporter. She is the Medical Doctor who will direct

patient referral, program guideline refinement, and make recommendations for change where

needed.

Dr. Anna L. Schwartz, Ph.D. FNP, FAAN., will function as a consultant. Anna has been very

involved with the development of our oncology rehabilitation services for the past year.

Dr. Wayne Samuelson, M.D. is the Medical Director of the pulmonary rehabilitation program.

Oncology rehabilitation is conducted with in pulmonary rehabilitation.

Long term sources / strategies for funding of the program.

Dr. Saundra S. Buys has consented to be the Principle Investigator for a larger scale study to be

proposed to the University of Utah Research Foundation. This seed grant is for $35,000.00

thousand dollar. We plane to increase the study to 30 subjects for this grant program in 1999.

After the seed grant study, we plan to propose a study to: The Behavioral Research in Cancer

Prevention and Control, a division of the National Cancer Institute. We plan to submit this

proposal in 2001.

A review of comparable programs offered in this service area and an

explanation of how this program is unique

We have been in communication and collaboration with the Oncology Rehabilitation

coordinator at the Cancer Treatment Center in Greenville, SC. Margaret Edwards, RN, MSN. has

provided their program guidelines, which have been helpful in developing our services. The

program in Greenville, SC. Started with 90 percent breast cancer patients and has been serving

many other types of cancer patients for six years. The cost of attending this program was

significantly higher then the cost of attending our program. For example; the cardiopulmonary

exercise test in Greenville costs $600.00 dollars,

compared to $218.90 in our facility. One phase II exercise session in Greenville costs $65

Dollars, our phase II session costs $47.80. We have also used information from the University of

Pennsylvania Cancer Center and The Kingsbury Center for Cancer Care in New Hampshire to

reinforce the development of our program guidelines.

Detailed Budget for Entire Budget Project Period.

Personnel

There is no request for support in this catagory.

Supplies

Books: $300.00

Office Supplies: $100.00

Development of the Oncology Rehabilitation Guidlined handout: $200.00

Work shop on Oncology Rehabilitation in Greenville, SC with Margret Edwards $400.00

Travel: $400.00

Quality of Well-Being scale addministration: $6 short form X 24 = $144.00

Total amount allowed after patient costs = 2000.00

Patient Care Costs

Rehabilitation orientation (90) minutes = $142.30

Twenty Four (24) phase II exercise sessions = $1,147.20

Two (2) Cardiopulmonary exercise tests = $437.80