Activity and Cancer Survivorship Exercise Pilot

NCT ID: NCT07283029

Last Updated: 2025-12-15

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2026-12-31

Brief Summary

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This early phase I clinical trial measures the changes in functional fitness following home-based comprehensive exercise program in patients who have endometrial cancer who have completed treatment. Endometrial cancer is an increasingly common diagnosis, with health and quality of life concerns persisting after the active cancer treatment period. Exercise in cancer survivors has the potential to reduce the risk of death by improving cardiovascular fitness, quality of life, strength, longevity, and independence. A home-based exercise programs may be a feasible approach for exercise programming in patients who have endometrial cancer who have completed treatment.

Detailed Description

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Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

Group Type EXPERIMENTAL

Functional fitness following home-based comprehensive exercise program

Intervention Type OTHER

Patients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study.

Interventions

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Functional fitness following home-based comprehensive exercise program

Patients complete a home-based exercise program, receive remote health coaching sessions, and complete functional fitness tests on study. Patients also wear a Fitbit and receive health education on study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willing to provide written informed consent
* Willing to comply with all study procedures and be available for the duration of the study
* Fluent in spoken and written English
* Women 18-74 years of age
* Documented diagnosis of type I, stage I-IIIc endometrial cancer within the past 5 years
* Completion of current treatment for endometrial cancer
* Technology access (cellphone with data, broadband internet, WiFi) for tele coaching
* Pass the Physical Activity Readiness Questionnaire (PAR-Q)

Exclusion Criteria

* Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
* Have evidence of recurrent or metastatic disease
* Are currently performing resistance training \>= 2 days per week
* Are currently exceeding 150 minutes of at least moderate intensity activity per week
* Report of chest pain, shortness of breath, fainting, or angina pectoris
* Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
* Plans to move from the area
* Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
* Women who are pregnant or breast-feeding
* Not suitable for study participation due to other reasons at the discretion of the investigator
* Failing the Physical Activity Readiness Questionnaire
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Jess S. Gorzelitz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Gorzelitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Holden Comprehensive Cancer Center

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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202212082

Identifier Type: -

Identifier Source: org_study_id

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