NCT05233059

Brief Summary

The purpose of this study is to determine whether a physical activity tracking program called FitEx would be useful to endometrial cancer survivors. Each interested endometrial cancer survivor will recruit 1 to 5 additional friends/family members to participate in the intervention with them, forming a team. Each team will be randomized to FitExEC (control group) that receives FitEx for endometrial cancer survivors, or FitExEC+yoga (experimental group) that receives FitEx for endometrial cancer survivors plus yoga cueing. FitExEC is based on FitEx, a program used to encourage adults to improve their fruit and vegetable intake while increasing their physical activity. FitEx works by having participants join a team with their friends and loved ones, so they can support one another in meeting their goals. In this study, teams of endometrial cancer survivors/support members will receive watches that track how much they walk. Each day, participants record how much exercise, how many fruits, and how many vegetables they've eaten that day for a total of 8 weeks. Participants will be encouraged to attend a virtual session 15 minutes per week that will focus on 1-mile worth of exercise points (all control) or 15 minutes of yoga (all experimental) followed by 15 minutes of support (endometrial cancer survivors only \[control and experimental survivors in different groups\]). Participation in the study lasts roughly 10 weeks, and participants will be followed for 6 months afterward. The investigators think that FitEx may help people with endometrial cancer improve their daily physical activity and slowly improve their health and quality of life. The investigators hypothesize this intervention is feasible and acceptable to Carilion Clinic endometrial cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2021

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

July 28, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

August 2, 2021

Last Update Submit

February 6, 2023

Conditions

Quality of LifeCancer of EndometriumBehavior, HealthSelf Efficacy

Keywords

WalkingYogaPhysical Activity AdherenceGoal SettingSocial Support

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Acceptability as measured by recruitment rate and program completion

    Our primary aims are program adherence, measured as the percentage of participants who complete the 8 week program, and recruitment rate, measured as the percentage of participants who join the study out of the total participants who are approached about the study. These outcomes will be used to assess the feasibility and acceptability of the study among participants who enroll in the study and percentage of participants who complete the program.

    8 weeks

Secondary Outcomes (5)

  • Changes to self-reported physical activity levels as measured by L-Cat questionnaire

    6 months

  • Changes to Quality of Life as measured by FACT-En questionnaire

    6 months

  • Changes to Yoga Self-Efficacy as measured by Yoga Self Efficacy questionnaire

    6 months

  • Self reported physical activity measured via steps per day on pedometer

    6 months

  • Changes to Fear of Cancer Recurrence measured by Fear of Cancer Recurrence Inventory questionnaire

    6 months

Study Arms (2)

Walking

ACTIVE COMPARATOR

The walking group will receive a tailored FitEx for endometrial cancer survivors, including cancer specific newsletters.

Behavioral: FitExBehavioral: Weekly Movement Sessions

Walking Plus Yoga

EXPERIMENTAL

The walking group will receive a tailored FitEx for endometrial cancer survivors with yoga cuing and yoga-based newsletters.

Behavioral: FitExBehavioral: Weekly Yoga Sessions

Interventions

FitExBEHAVIORAL

FitEx is an 8 week goal-setting, behavior tracking, physical activity intervention with a low dose of social support which will be delivered virtually.

WalkingWalking Plus Yoga
Weekly Yoga SessionsBEHAVIORAL

30 minutes of optional guided yoga online led by a 500 hour yoga teacher once a week for participants in the walking plus yoga arm. Also accompanied by a yoga based newsletter.

Walking Plus Yoga
Weekly Movement SessionsBEHAVIORAL

30 minutes of optional guided movement online led by a 500 hour yoga teacher once a week for participants in the walking arm. Also accompanied by a movement based newsletter.

Walking

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with early stage (I-II) endometrial cancer, any histology
  • Received cancer care at Carilion Clinic after 1/1/2010
  • At least 18 years of age
  • Have adequate comprehension (reading and writing) of the English language
  • Have a BMI ≥ 30 kg/m\^2 at screening
  • Have stable internet access or access to a smartphone with internet
  • Meet the requirements of the Physical Activity Readiness Questionnaire (PARQ)
  • Have the capacity to provide informed consent and are willing to provide informed consent

You may not qualify if:

  • History of recurrent endometrial cancer TARGET - Vital status: deceased
  • Are meeting physical activity guidelines set forth by the American Cancer Society at screening (greater than 150 minutes/week of moderate physical activity, or greater than 75 minutes/week of vigorous physical activity)
  • Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely
  • Healthy volunteers can be either gender with criteria below:
  • Were identified by a participant with endometrial cancer as a member of their support system
  • Are at least 18 years of age
  • Have adequate comprehension (reading and writing) of the English language
  • Have stable internet access or access to a smartphone with internet capabilities
  • Meet the requirements of the Physical Activity Readiness Questionnaire(PARQ)
  • Have the capacity to provide informed consent and are willing to provide informed consent
  • Have functional limitations requiring a walker, wheelchair, scooter, or 6 other walking aid which limits their capacity to engage in the intervention safely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, 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

Related Links

MeSH Terms

Conditions

Endometrial NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehavior

Study Officials

  • Shannon Armbruster, MD, MPH

    Carilion Clinic Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 arm randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

February 10, 2022

Study Start

July 28, 2021

Primary Completion

October 30, 2021

Study Completion

May 30, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)