NCT02255240

Brief Summary

The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

September 29, 2014

Last Update Submit

May 26, 2015

Conditions

Breast CancerObesity

Keywords

breast cancercancersurvivorshipcancer survivorphysical activityvideo gamewomenwomen's health

Outcome Measures

Primary Outcomes (1)

  • Change in physical activity from baseline to 6 weeks

    Minutes of moderate-vigorous physical activity measured over a 7 day period

    6 weeks

Secondary Outcomes (5)

  • Change in physical fitness from baseline to 6 weeks

    6 weeks

  • Change in weight from baseline to 6 weeks

    6 weeks

  • Change in motivation from baseline to 6 weeks

    6 weeks

  • Change in body function from baseline to 6 weeks

    6 weeks

  • Change in quality of life from baseline to 6 weeks

    6 weeks

Other Outcomes (4)

  • Number of participants who drop out of the study from baseline to 6 weeks

    6 weeks

  • Acceptability

    6 weeks

  • Number of participants who report adverse events

    6 weeks

  • +1 more other outcomes

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

This arm will receive the physical activity intervention, which consists of three individual meetings, weekly brief counseling phone calls for 6 weeks, and provision of a video game console with three active video games.

Behavioral: Physical activity intervention

Interventions

Physical activity interventionBEHAVIORAL

Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.

Physical activity intervention

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Aged 45 - 75
  • Diagnosed with breast cancer within the past 10 years

You may not qualify if:

  • Chemotherapy or radiation treatment in the past six months
  • Surgery in the past six months
  • Evidence of disease recurrence
  • Unable to read and understand English
  • Unable to see a TV screen from several feet away
  • Unable to find transportation to the study location
  • No Internet access in the home (only for intervention portion of the study)
  • Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
  • BMI is under 18.5 kg/m2 or over 40 kg/m2
  • Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia.
  • Inadequate performance on Senior Fitness Test, indicating inability to engage in video game exercise procedures (total score \< 9 out of 12)
  • Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician
  • Unable to walk, jump, and jog as may be required by some games (self-report)
  • Report current symptoms of alcohol or substance dependence
  • Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsObesityNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Elizabeth J Lyons, PhD, MPH

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 2, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 27, 2015

Record last verified: 2014-09

Locations

US(1)