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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG024832 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| National Institute on Aging (NIA) | NIH |
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Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior.
The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.
Increasing and maintaining physical activity among female breast cancer (BC) survivors during treatment remains an unresolved problem in BC survivorship care. BC survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decline of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-less than 30% of survivors met physical activity recommendations. Physical activity interventions have shown effectiveness in helping BC survivors increase activity during treatment, but limited evidence-based activity interventions have been disseminated into the clinic and community. To address this limitation, we are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior, which will investigate the feasibility of implementing active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Participants (N = 60) will be randomized to participate in the support group using the active video game-based physical activity intervention or to participate in the existing UTMB breast cancer support group with pedometers. Our specific aims are:
Aim 1: Evaluate the feasibility and acceptability of active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Measures of feasibility will include weekly attendance records, number of completed home-based worksheets, number of participants completing the program activities, technological issues, and adverse events.
Aim 2: Compare the support group using the active video game-based physical activity intervention to the existing UTMB breast cancer support group with pedometer. Primary outcomes will be changes in physical activity. Secondary outcomes will be changes in physical function, dietary pattern, and quality of life.
Aim 3: Develop tools for implementation of the Pink Warrior intervention within the clinic and community settings. A trainer's manual for the Pink Warrior intervention will be developed and UTMB Breast Cancer Support Group facilitators will be trained by research staff to implement the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active video game teleconference support group | Experimental | 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. |
|
| Standard support group + pedometer | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active video game teleconference support group | Behavioral | 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks | Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment | Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks | 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. | Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Skills in Daily Life | Walking skills as measured by the Figure-of-8 Walk test | Baseline to 14 weeks |
| Hand Grip Strength | Flexor muscle strength of hand and forearm measured by dynamometer |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J Lyons, PhD, MPH | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch | Galveston | Texas | 77555 | United States | ||
| UT MD Anderson Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks | Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment | One person dropped out of the study shortly after randomization in the standard group and did not have a baseline step value | Posted | Mean | Standard Deviation | steps | Baseline to 14 weeks |
|
12 weeks
PI review of screening call logs, group session documentation, and data collection was used to systematically assess instances of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Due to COVID-19 restrictions, we were unable to complete collection of Senior Fitness Test or hand grip measures. These were moved from secondary to other pre-specified outcomes. Other objective measures were collected via videoconference.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eloisa Martinez | The University of Texas Medical Branch | 409-266-9643 | esmartin@utmb.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2022 | Mar 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Standard support group + pedometer | Behavioral | 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 | 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. | Baseline to 14 weeks |
| Baseline to 14 weeks |
| Physical Function as Measured by the Senior Fitness Test | 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 | Baseline to 14 weeks |
| Body Weight in kg | Mean body weight as measured by a calibrated scale in a cancer clinic setting | Baseline to 14 weeks |
| Waist Circumference in cm | Mean waist circumference as measured by Seca-203 measuring tape | Baseline to 14 weeks |
| Dietary Pattern | 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 | Baseline to 14 weeks |
| Self-reported Physical Activity Minutes | Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire | Baseline to 14 weeks |
| Self-reported Physical Function | Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function) | Baseline to 14 weeks |
| Fatigue | Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue) | Baseline to 14 weeks |
| Exercise Motivation Measured as Autonomous Regulation | Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2 | Baseline to 14 weeks |
| Psychological Feelings Related to Exercise | 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. | Baseline to 14 weeks |
| Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS) | 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.) | Baseline to 14 weeks |
| Feasibility - Adherence | Adherence as measured by number of participants who complete at least 80% of program activities | Baseline to 14 weeks |
| Feasibility - Attrition | Attrition as measured by percentage of people who drop out of the program | Baseline to 14 weeks |
| Feasibility - Technological Issues | Technological issues will be measured by counting the number of reported occurrences | Baseline to 14 weeks |
| Feasibility - Adverse Events | Adverse events will be measured by counting the number of occurrences | Baseline to 14 weeks |
| Acceptability Scale | 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.) | Baseline to 14 weeks |
| Houston |
| Texas |
| 77054 |
| United States |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
|
| Secondary | Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks | 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. | One person dropped out of the standard group shortly after randomization. An additional person in each group had missing values at baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 14 weeks |
|
|
|
|
| Secondary | Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks | 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. | One person in the standard group dropped out of the study shortly after randomization. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 14 weeks |
|
|
|
|
| Other Pre-specified | Walking Skills in Daily Life | Walking skills as measured by the Figure-of-8 Walk test | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Hand Grip Strength | Flexor muscle strength of hand and forearm measured by dynamometer | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Physical Function as Measured by the Senior Fitness Test | 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 | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Body Weight in kg | Mean body weight as measured by a calibrated scale in a cancer clinic setting | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Waist Circumference in cm | Mean waist circumference as measured by Seca-203 measuring tape | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Dietary Pattern | 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 | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Self-reported Physical Activity Minutes | Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Self-reported Physical Function | Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function) | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Fatigue | Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue) | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Exercise Motivation Measured as Autonomous Regulation | Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2 | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Psychological Feelings Related to Exercise | 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. | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS) | 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.) | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Feasibility - Adherence | Adherence as measured by number of participants who complete at least 80% of program activities | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Feasibility - Attrition | Attrition as measured by percentage of people who drop out of the program | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Feasibility - Technological Issues | Technological issues will be measured by counting the number of reported occurrences | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Feasibility - Adverse Events | Adverse events will be measured by counting the number of occurrences | Not Posted | Baseline to 14 weeks | Participants |
| Other Pre-specified | Acceptability Scale | 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.) | Not Posted | Baseline to 14 weeks | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |