NCT02575872

Brief Summary

This randomized clinical trial studies a physical activity behavioral intervention in obese endometrial cancer survivors. Learning about physical activity behavior while participating in a fitness class may help increase physical activity and improve the quality of life of obese endometrial cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

4.5 years

First QC Date

October 13, 2015

Last Update Submit

September 13, 2019

Conditions

Stage IA Uterine Corpus CancerStage IB Uterine Corpus CancerStage II Uterine Corpus CancerStage IIIA Uterine Corpus CancerStage IIIB Uterine Corpus CancerStage IIIC Uterine Corpus CancerStage IVA Uterine Corpus CancerStage IVB Uterine Corpus Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants completing at least 150 minutes of moderate-vigorous physical activity, assessed by the Yale Physical Activity Survey (YPAS)

    Data will be analyzed using Pearson Chi-square test.

    12 weeks

Secondary Outcomes (12)

  • Barrier avoidance/coping, measured using 5 point Likert scales

    Up to 12 weeks

  • BMI

    Up to 12 weeks

  • Change in ability to perform activities of daily living, assessed with the YPAS

    Baseline to 12 weeks

  • Change in sedentary time, assessed with the YPAS

    Baseline to 12 weeks

  • Exercise efficacy, measured using 5 point Likert scales

    Up to 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Participants partake in 30 minutes of group discussions regarding physical activity behavior followed by 60 minutes of moderate-intensity exercise comprised of 5 minutes warm-up, 25 minutes cardiovascular training, 20 minutes of resistance training exercises using body weight and exercise band, and 10 minutes of cool-down and stretching once weekly for 12 weeks. Participants also complete a brisk walk for 90 minutes per week outside of class for 12 weeks.

Behavioral: Exercise Intervention

wait-list for intervention

NO INTERVENTION

Participants receive a handout indicating the importance of physical activity and improved nutrition for health outcomes. After 12 weeks, patients are invited to participate in the physical behavior intervention as in Group I.

Interventions

Exercise InterventionBEHAVIORAL

Participate in physical activity behavioral intervention

Exercise Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent form signed and dated by the subject
  • English and/or Spanish speaking
  • History of endometrial cancer stage I-IV \> 6 months \< 5 years, not currently receiving cancer treatment
  • Overweight (body mass index \[BMI\] \>= 30)
  • Eastern Cooperative Oncology Group performance status (PS) of 0 - 2
  • Medically capable of performing moderate intensity exercise

You may not qualify if:

  • Must not have engaged in a regular (\> 3x/week, physical activity program in the last 6 months)
  • Medical contraindication to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PMID: 36971688DERIVED

Study Officials

  • Nicole Nevadunsky

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

October 1, 2013

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

US(1)