Trial Outcomes & Findings for Pink Warrior 2: Teleconference-based Gaming Support (NCT NCT04259905)

NCT ID: NCT04259905

Last Updated: 2023-06-08

Results Overview

Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 14 weeks

Results posted on

2023-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Active Video Game Teleconference Support Group Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device	Standard Support Group + Pedometer Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
Overall Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pink Warrior 2: Teleconference-based Gaming Support

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Video Game Teleconference Support Group n=10 Participants Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device	Standard Support Group + Pedometer n=10 Participants Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer	Total n=20 Participants Total of all reporting groups
Age, Continuous	64.90 years STANDARD_DEVIATION 8.03 • n=5 Participants	62.60 years STANDARD_DEVIATION 4.20 • n=7 Participants	63.75 years STANDARD_DEVIATION 6.35 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 14 weeks

Population: One person dropped out of the study shortly after randomization in the standard group and did not have a baseline step value

Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment

Outcome measures

Outcome measures
Measure	Active Video Game Teleconference Support Group n=10 Participants Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device	Standard Support Group + Pedometer n=9 Participants Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks	-229.52 steps Standard Deviation 1905.94	1570.17 steps Standard Deviation 2355.59

SECONDARY outcome

Timeframe: Baseline to 14 weeks

Population: One person dropped out of the standard group shortly after randomization. An additional person in each group had missing values at baseline.

Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure at follow-up, scored for physical, social, emotional, functional, and breast well-being (here we report the total score of these subscales). The range for this scale is 0-123, with 0 indicating a better outcome.

Outcome measures

Outcome measures
Measure	Active Video Game Teleconference Support Group n=9 Participants Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device	Standard Support Group + Pedometer n=8 Participants Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks	8.72 units on a scale Standard Deviation 10.07	-1.69 units on a scale Standard Deviation 2.84

SECONDARY outcome

Timeframe: Baseline to 14 weeks

Population: One person in the standard group dropped out of the study shortly after randomization.

Difference in physical performance as measured by Short Physical Performance Battery from baseline to 14 weeks. The numbers reported here are the sum of scores from the subscales. The range for this measure is between 0-12, with lower scores indicating better outcomes.

Outcome measures

Outcome measures
Measure	Active Video Game Teleconference Support Group n=10 Participants Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag. Active video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device	Standard Support Group + Pedometer n=9 Participants Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag. Standard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer
Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks	1.6 units on a scale Standard Deviation 1.17	0.44 units on a scale Standard Deviation 1.01

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Walking skills as measured by the Figure-of-8 Walk test

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Flexor muscle strength of hand and forearm measured by dynamometer

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Physical function scores on six components: chair stands, arm curls, chair sit and reach, back scratch, 8 foot up and go, and 2 minute step in place test

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Mean body weight as measured by a calibrated scale in a cancer clinic setting

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Mean waist circumference as measured by Seca-203 measuring tape

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Dietary pattern change measured by the National Health and Nutrition Examination Survey (2009-10) measuring fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Perceptions of autonomy, competence, and relatedness as measured by the Basic Psychological Needs in Exercise scale. 11 items on a 5-point Likert scale. Range: 1 (I do not agree at all) to 5 (I completely agree) for each of the constructs-autonomy (1-20), competence (1-20), and relatedness (1-15). The higher the score means more autonomy, more competence, and relatedness.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Goal-setting and planning measures, adapted from a published, untitled series of items created by Rovniak et al for evaluation of technology-mediated health promotion content. 10 EGS and 10 EPS items on a 5-point Likert scale. Range: 1 (does not describe) to 5 (describes completely) of the goal setting and planning strategies. The higher the score means more exercise goal-setting and planning behavior. (Rovniak et al. Annals of Behavioral Medicine, 2002, 24(2): 149-156.)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Adherence as measured by number of participants who complete at least 80% of program activities

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Attrition as measured by percentage of people who drop out of the program

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Technological issues will be measured by counting the number of reported occurrences

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Adverse events will be measured by counting the number of occurrences

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 14 weeks

Acceptability and satisfaction will be assessed via Vandelanotte questionnaire with 5-point scale responses, measures are adapted from a published, untitled series of items created by Vandelanotte et al for evaluation of technology-mediated health promotion content. Acceptability and feasibility of 3 components on a 5-point Likert scale-activity monitor (7-item), program team (6-item), and the program itself (15-item). Ranged: 1 (strongly disagree) to 5 (strongly agree). The higher the score means that it is more acceptable and feasible. (Vandelanotte, C. and I. De Bourdeaudhuij (2003). "Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: project FAITH." Health Educ Res 18(3): 304-317 and Vandelanotte, C., et al. (2004). "Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium." Health Promot Int 19(4): 463-470.)

Outcome measures

Outcome data not reported

Adverse Events

Active Video Game Teleconference Support Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Support Group + Pedometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eloisa Martinez

The University of Texas Medical Branch

Phone: 409-266-9643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place