Self-monitoring Activity: a Randomized Trial of Game-oriented Applications

NCT02341235 | Completed Results

• 1 other identifier: 14-0376
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.

Conditions

Breast Cancer; Obesity

Keywords

video game; narrative; story; survivorship; cancer survivor; mhealth; physical activity; women; women's health

Outcome Measures

Primary Outcomes (1)

• Change in Minutes Per Day of Physical Activity

  Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.

  baseline and 6 months

Secondary Outcomes (15)

• Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test

  baseline to 6 months

• Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure

  baseline to 6 months

• Change in Weight From Baseline to 6 Months

  baseline to 6 months

• Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure

  baseline to 6 months

• Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity

  baseline to 6 months

Other Outcomes (20)

• Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test

  baseline to 6 months

• Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test

  baseline to 6 months

• Change in Sleep From 6 Months to 1 Year

  baseline to 6 months

Study Arms (2)

Game intervention

EXPERIMENTAL

Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)

Behavioral: Game intervention

Standard intervention

ACTIVE COMPARATOR

Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)

Behavioral: Standard intervention

Interventions

Game intervention BEHAVIORAL

The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.

Game intervention

Standard intervention BEHAVIORAL

The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.

Standard intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 45 and 75 years old
• Report a breast cancer diagnosis no more than 10 years prior to enrollment
• Cessation of menses for 12 months or more
• Able to read and understand English
• Able to read words in standard applications on a mobile device 3-4" large
• Able to walk for exercise
• Able to find transportation to the study location
• Willing to use a mobile device provided by the study to participate (or to use one of their own)
• Willing to be randomized to either group

You may not qualify if:

• Currently pregnant or nursing
• Surgery in the past six months
• Chemotherapy or radiation treatment in the past six months
• Evidence of disease recurrence
• Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
• BMI is under 25 kg/m2 or over 35 kg/m2
• 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
• Participant reports hospitalization within the past year due to psychiatric problem(s)
• 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
• Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
• Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
• Clinical judgment concerning safety
• Lost more than 5% body weight in the previous 6 months
• Currently participating in a physical activity or weight loss program

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (1)

• Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.

  PMID: 26960972 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Obesity; Narration; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Limitations and Caveats

Please interpret numerical outcomes with caution due to large amounts of drop out and low adherence in this pilot trial. All pre-specified PROMIS outcomes that were collected are provided, but note that these measures in particular faced a large amount of missing data.

Results Point of Contact

• Title: Eloisa Martinez
• Organization: The University of Texas Medical Branch

esmartin@utmb.edu

409-266-9643

Study Officials

• Elizabeth Lyons, PhD, MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 19, 2015
• Study Start: February 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Locations

US (1)