Integration of Exercise Into Cancer Care: A Shared Care Model

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.

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Physical activity

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavik, Iceland, 101
    • Recruiting
    • Landspitali - The National University Hospital of Iceland
    • Contact: Halla Arnardottir; Phone Number: +354-543-1000; Email: hallarn@lsh.is
    • Contact: Eyrun Steinsson; Phone Number: 1465 +354-543-1000; Email: eyrunst@lsh.is
    • Sub-Investigator: Runolfur Palsson, MD
• United States
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Gundersen Health System
      • Contact: Kurt Oettle, MD; Phone Number: 608-782-7300
      • Contact: Amee Vang, MPH; Phone Number: 608-775-7816; Email: cavang@gundersenhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; No intervention
Active Comparator: Shared care; Clinic visit with Clincal Exercise Physiologist or physical therapist who does assessment and prescripes individulized physical activity plan	Behavioral: Physical activity; Patients in shared care arm has regular combined visits with Oncologist and Clincal Exercise Physiologist (CEP). Individual physical activity plan developed by CEP for patients in shared care arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - General (FACT-G QOL) measurement.	Change in score of FACT-G QOL measurement.	Month 0 (first visit), month 1, month 3, month 6, month 9, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	Change in 6-minute walk test	Month 0 (first visit), month 1, month 3, month 6, month 9, month 12
International Physical Activity Questionnaire (IPAQ) score	Change in International Physical Activity Questionnaire (IPAQ) score	Month 0 (first visit), month 1, month 3, month 6, month 9, month 12
Patient Health Questionnaire 9 (PHQ-9) score	Change in Patient Health Questionnaire (PHQ) score	Month 0 (first visit), month 1, month 3, month 6, month 9, month 12

Collaborators and Investigators

• Sponsor: Landspitali University Hospital
• Collaborators: Gundersen Health System
• Investigators: Principal Investigator: Agnes Smaradottir, MD, Landspitali University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Adjuvant chemotherapy; Physical activity
• Other Study ID Numbers: LSH-18-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No