Integration of Exercise Into Cancer Care: A Shared Care Model

Sponsor

Landspitali University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03661242

Collaborator

Gundersen Health System (Other)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Physical activity	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

The design is a quasi-experimental prospective double- cohort study in which a lead-in group will be enrolled and receive standard of care and an intervention group will be enrolled one year after the last lead-in patient is accrued. The intervention group will receive shared care with an oncologist and an exercise physiologist trained in providing activity and exercise guidelines to the cancer patient population.The design is a quasi-experimental prospective double- cohort study in which a lead-in group will be enrolled and receive standard of care and an intervention group will be enrolled one year after the last lead-in patient is accrued. The intervention group will receive shared care with an oncologist and an exercise physiologist trained in providing activity and exercise guidelines to the cancer patient population.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Integration of Exercise Into Cancer Care: A Shared Care Model

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gundersen Health System	La Crosse	Wisconsin	United States	54601
2	Landspitali - The National University Hospital of Iceland	Reykjavik		Iceland	101

Sponsors and Collaborators

Landspitali University Hospital
Gundersen Health System

Investigators

Principal Investigator: Agnes Smaradottir, MD, Landspitali University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Landspitali University Hospital

ClinicalTrials.gov Identifier:

NCT03661242

Other Study ID Numbers:

LSH-18-001

First Posted:

Sep 7, 2018

Last Update Posted:

May 20, 2019

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Landspitali University Hospital

Physical activity

Exercise

Adjuvant chemotherapy

Study Results

No Results Posted as of May 20, 2019