Integration of Exercise Into Cancer Care: A Shared Care Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multicomponent Physical Activity Intervention for the Reduction of Psychosocial Distress in Cancer Patients

NCT05056831

Anxiety Disorder Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

TERMINATED NA

Rehabilitation - Physical Activity and Coping

NCT04245943

Cancer Survivors

ACTIVE_NOT_RECRUITING NA

Sustaining Physical Activity After Cancer Exercise Sessions

NCT06359210

Exercise Oncology Physical Activity Behavior Behavior Change Interventions

RECRUITING NA

Physical Activity and Healthy Eating Among Young Adult Cancer Survivors

NCT05887401

Physical Activity Neoplasms Cancer

COMPLETED NA

Community-Based Physical Activity Intervention for Underserved Cancer Survivors

NCT06206863

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Shared care

Clinic visit with Clincal Exercise Physiologist or physical therapist who does assessment and prescripes individulized physical activity plan

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No