NCT03661242

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable cancer

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 20, 2019

Status Verified

August 1, 2018

Enrollment Period

4.3 years

First QC Date

September 5, 2018

Last Update Submit

May 16, 2019

Conditions

Cancer

Keywords

Physical activityExerciseAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 6-minute walk test

    Month 0 (first visit), month 1, month 3, month 6, month 9, month 12

  • 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

    Month 0 (first visit), month 1, month 3, month 6, month 9, month 12

Study Arms (2)

Standard of care

NO INTERVENTION

No intervention

Shared care

ACTIVE COMPARATOR

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

Behavioral: Physical activity

Interventions

Physical activityBEHAVIORAL

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.

Shared care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Pathologic confirmed cancer diagnosis
  • Patients receiving adjuvant treatment (chemotherapy and/or radiation) with curative intent
  • ECOG performance status 0-2

You may not qualify if:

  • Unable to ambulate
  • Comorbidity contraindicated PA as per treating physician
  • Non-English speaker
  • Receiving maintenance chemotherapy
  • Breast cancer diagnosis
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

RECRUITING

Landspitali - The National University Hospital of Iceland

Reykjavik, 101, Iceland

RECRUITING

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Agnes Smaradottir, MD

    Landspitali University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Smaradottir, MD

CONTACT

+ 354 5431000agnessma@landspitali.is

Halla Arnardottir, RN

CONTACT

+354 5435711hallarn@landspitali.is

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 20, 2019

Record last verified: 2018-08

Locations

US(1)IC(1)