Activity and Cancer Survivorship Exercise Pilot

NCT07283029 | Active Not Recruiting DMC

• 1 other identifier: 202212082
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Chair sit to stand test

  Will be assessed using the Functional Fitness Test, which is a battery of six tests including the 30 second chair stand, the 30 second arm curl, the 6-minute walk, the chair sit and reach, the 8-foot up and go, and the back scratch tests. Mixed effects regression models will be used to estimate changes in each of the 6 tests included in the Functional Fitness Test from pre- to post-intervention. Random effects will be included to account for the longitudinally correlated nature of repeat measurements within a patient. Estimated mean changes and associated 90% confidence intervals will be reported. Primary outcome is number of repetitions in the chair sit to stand test

  baseline, pre-intervention and immediately after the intervention

Secondary Outcomes (7)

• Incidence of adverse events

  Up to 10 weeks

• Muscle strengthening exercise session adherence

  Up to 10 weeks

• Aerobic physical activity adherence

  Up to 10 weeks

• Tele coaching adherence

  Up to 10 weeks

• Exercise program acceptability

  Up to 10 weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Other: Functional fitness following home-based comprehensive exercise program

Interventions

Functional fitness following home-based comprehensive exercise program 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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 55242, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jessica Gorzelitz, PhD

  University of Iowa Holden Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: February 9, 2023
• Primary Completion: December 6, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)