Recruiting

Exercise

Sponsor:

Landspitali University Hospital

Code:

NCT03661242

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical activity

Study Details

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.

Conditions

Cancer

Study ID

NCT03661242

Start date

Oct 1, 2018

Status verified date

Aug, 2018

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Functional Assessment of Cancer Therapy - General (FACT-G QOL) measurement. [ Time Frame: Month 0 (first visit), month 1, month 3, month 6, month 9, month 12 ]

Central Contacts and Locations

Central contacts

Agnes Smaradottir, MD

+ 354 5431000agnessma@landspitali.is

Halla Arnardottir, RN

+354 5435711hallarn@landspitali.is

Locations

Gundersen Health System

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Kurt Oettle, MD

608-782-7300

Amee Vang, MPH

608-775-7816cavang@gundersenhealth.org

More Information

Sponsor

Landspitali University Hospital

Last update posted

May 20, 2019

Last verified

Aug, 2018

Keywords

  • Physical activity
  • Exercise
  • Adjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Landspitali University Hospital on 2019-05-20.