N/A N=90 Randomized Single-blind Supportive Care

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

Breast Cancer · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02341235 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jul 2024

Primary outcome: Primary: Change in Minutes Per Day of Physical Activity — 20.87; 15.82 minutes per day — p=.35

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Game intervention (Behavioral); Standard intervention (Behavioral)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: The University of Texas Medical Branch, Galveston
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Minutes Per Day of Physical Activity	20.87; 15.82	.35
SECONDARY Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test	-44.35; 71.74	0.22
SECONDARY Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure	.33; .4	.97
SECONDARY Change in Weight From Baseline to 6 Months	-.14; -.04	.98
SECONDARY Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure	-1.11; -1.39	.83
SECONDARY Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity	.11; .62	.055
SECONDARY Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale	-.74; -1.53	.71
SECONDARY Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale	-1.76; -.27	.33
SECONDARY Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale	.72; .6	.94
SECONDARY Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale	-0.03; -.96	.57
SECONDARY Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity	.01; .30	.30
SECONDARY Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity	.32; .53	.44
SECONDARY Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure	.39; 1.04	.62
SECONDARY Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure	-.05; .29	.70
SECONDARY Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure	1.32; -.57	.41
SECONDARY Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test	.68; .26	.72

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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
Current smoker
Participant already uses an electronic activity monitor (we will ask them to stop)
Another member of the household is a participant or staff member on this trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02341235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.