Integration of Exercise Into Cancer Care: A Shared Care Model



Status:Not yet recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:October 1, 2018
End Date:December 31, 2022
Contact:Agnes Smaradottir, MD
Email:agnessma@landspitali.is
Phone:+ 354 5431000

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Multiple organizations endorse physical activity for cancer patients; however the structure
for oncologist prescribed exercise has not been clearly established. A focus group study
previously conducted at Gundersen Health System identified a patient preference for
integrated care surrounding physical activity. Thus, the focus of this study will be to
investigate the effects of a shared care model on the physical activity levels of cancer
patients. The shared care model will consist of regularly scheduled visits with the patient's
oncologist in combination with a clinical exercise physiologist. The clinical exercise
physiologist (CEP) will assist in developing an individual activity plan with the patient.
The Investigators predict the shared care model patients will have a higher level of
activity, functional capacity and quality of life.

Numerous organizations, including the American Cancer Society, American College of Sports
Medicine, National Comprehensive Cancer Network, U.S. Department of Health and Human
Resources and Oncology Nursing Society have endorsed physical activity for cancer patients
both when undergoing treatment and during the survivorship phase of care. Previous studies
have consistently found physical activity to be associated with improved quality of life.
However, current guidelines for oncologist prescribed exercise are vague and not supported
with adequate training and/or education.

A focus group study previously conducted at Gundersen Health System found that oncologists'
reluctance to discuss physical activity with patients is rooted in their own ability to
safely guide patients through an exercise program. Cancer patients have also reported
uncertainty about what types, frequency and intensity of physical activity in which to engage
and it has been suggested that a referral process is critical to inclusion of exercise
prescription into cancer care. Investigator´s previous study, along with others, have found
that patients want advice and support about exercise while enduring the physiological and
psychological side effects of treatment, yet do not want to be referred elsewhere. Thus, it
seems there is a dilemma of translating safe and sustainable physical activity into standard
cancer care.

A potential solution to this perceived shortcoming is a shared care model of cancer care
delivery, wherein an oncologist is partnered with a certified exercise physiologist or
physical therapist to develop an individualized, holistic care plan for each patient. In
addition to providing the patient with standard of care cancer therapy as prescribed by the
oncologist, the shared care model will also provide the patient with a customized physical
activity plan developed by the exercise physiologist in consultation with the oncology staff
and after meeting with the patient during a regularly scheduled oncology office visit. In
this study the Investigators propose to investigate the impact of shared care visits with an
oncologist and exercise physiologist on quality of life and functional capacity during cancer
treatment. This model provides patients with easy access to the advice and support they
desire without the need for additional referrals and travel, while ensuring a comprehensive
assessment of risks and the development of safe progression of activities. Plan is to recruit
total of 120 patients.

Statistical analysis will utilized a mix of descriptive and comparative statistics.
Descriptive metrics will include means and associated 95% confidence intervals, medians and
frequency counts. Comparison of demographic and clinical factors between study groups will
utilize the Chi-square test for categorical data, the Wilcoxon rank sum test or
Kruskal-Wallis test for ordinal discrete or non-normally distributed continuous data and
Student's t-test or ANOVA for normally distributed continuous data. Evaluation of the primary
outcome will utilize repeated measures ANOVA to compare the change overall quality of life
over the study period, assessed via the FACT-G instrument, between the study groups. A
p-value < 0.05 will be used as the threshold for statistical significance for all tests.

Inclusion Criteria:

- 18 years and older

- Pathologic confirmed cancer diagnosis

- Patients receiving adjuvant treatment (chemotherapy and/or radiation) with curative
intent

- ECOG performance status 0-2

Exclusion Criteria:

- Unable to ambulate

- Comorbidity contraindicated PA as per treating physician

- Non-English speaker

- Receiving maintenance chemotherapy

- Breast cancer diagnosis

- Pregnant women
We found this trial at
2
sites
1900 South Avenue
La Crosse, Wisconsin 54601
Phone: 608-782-7300
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