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Survivors of breast cancer with functional limitations have a 40% higher mortality rate than those without. Despite the known benefits of physical activity (PA), <40% of survivors of breast cancer meet the recommendations for PA. The combination of active video games (AVGs) and group-based PA counseling may hold potential for motivating PA adoption and improving physical function. However, this method has not been widely studied in survivors of breast cancer.
We aimed to determine the feasibility and acceptability of a group AVG-based multicomponent PA intervention and estimate its effect size and variability on PA and physical function in female survivors of breast cancer in a clinic setting.
Female survivors of breast cancer (N=60) were recruited through the clinic and randomly assigned to the intervention group (12 weekly sessions) or the control group (existing support group). The intervention group received game-based pedometers and participated in weekly group AVG sessions, PA behavioral coaching, and survivorship navigation discussions. A participant manual with weekly reflection worksheets was provided to reinforce the coaching lessons and promote self-led PA. The control group received conventional pedometers and participated in an existing breast cancer support group. Feasibility was assessed by enrollment rate (≥50%), retention rate (≥80%), group attendance rate (75% attending ≥9 sessions [intervention group]), and the number of technological issues and adverse events. Acceptability was measured by participants’ attitudes (from strongly disagree=1 to strongly agree=5) toward the use of AVGs and the overall program. The outcomes included PA (accelerometers) and physical function (Short Physical Performance Battery and gait speed). Analysis of covariance was used to determine differences in PA and physical function between the groups. The Cohen
Participants were an average of 57.4 (SD 10.5) years old, 70% (42/60) White, and 58% (35/60) off treatment. The enrollment rate was 55.9% (66/118). Despite substantial long-term hurricane-related disruptions, we achieved an 80% (48/60) retention. The intervention group’s attendance rate was 78% (14/18), whereas the control group’s attendance rate was 53% (9/17). Of the 26 game-based pedometers, 3 (12%) were damaged or lost. No study-related adverse events occurred. Acceptability items were highly rated. Steps (
The intervention was feasible and acceptable in this population despite the occurrence of a natural disaster. Pilot results indicate that group AVG sessions, PA coaching, and survivorship navigation produced moderate effects on PA and physical functioning. AVGs with PA counseling can potentially be used in existing breast cancer support groups to encourage PA and improve physical function.
ClinicalTrials.gov NCT02750241; https://clinicaltrials.gov/ct2/show/NCT02750241
With advances in the diagnosis and treatment of breast cancer, there are currently >3.8 million female survivors of breast cancer from diagnosis to end of life [
Physical activity (PA) is a key approach to mitigating functional decline and improving QOL [
Although many successful behavior-based PA interventions have been effective in helping survivors increase their activity, these interventions are not without limitations [
By meeting basic psychological needs (competence, autonomy, and relatedness), SDT posits that it will help promote autonomous motivation and increase PA [
Among the few studies on group-based PA interventions is a recent meta-analysis that found that survivors who participated in group- and behavior-based PA interventions showed greater improvement in physical function than those who participated in an individual-based PA intervention [
The wide implementation of an evidence-based PA intervention in clinics and communities could effectively address the need for PA during and after cancer treatment in survivors of breast cancer [
Among survivors of breast cancer, commonly cited reasons associated with the decline in activity level are fatigue, physical discomfort, and lack of belief in their ability to be active again (known as self-efficacy) [
Previous studies that used AVGs in survivors of breast cancer and other survivors of cancer demonstrated that AVG interventions improved physical function (eg, muscle strength, range of motion, and QOL) [
The primary aims of this pilot study were to (1) determine the feasibility and acceptability of a clinic-based multicomponent PA intervention (
We adapted the
Although the focus of this study is not the theoretical framework, methods, and components we used to develop the intervention, we have included the following summary to facilitate future replication of our
Pink Warrior logic model. AVG: active video game; NCCS: National Coalition for Cancer Survivorship; PA: physical activity.
Our pilot study reporting was prepared in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement for randomized pilot and feasibility trials [
CONSORT (Consolidated Standards of Reporting Trials) pilot and feasibility flow diagram.
Participants were randomly assigned to the PA intervention that combined AVG group play, PA behavioral coaching, and breast cancer support (intervention group) or to participate in the existing breast cancer support group at the study clinic with a pedometer (control group). We used the randomization procedure previously reported by Lyons et al [
All participants attended 4 scheduled informed consent and assessment visits. The study flow is summarized in
Study flow diagram.
The Institutional Review Board at the University of Texas Medical Branch approved all procedures (protocol number: 16-0040), and our study was registered at ClinicalTrials.gov before data collection (NCT02750241).
The participants assigned to the intervention group took part in 12 weekly in-person, multicomponent PA intervention sessions. Participants were given a participant manual that contained weekly PA behavioral skill-building topics, self-led reflection worksheets, and breast cancer support discussion topics. Each of the in-person weekly group sessions consisted of three components: (1) a
Within the
AVGs that involved motion-controlled movement were used for the
Examples of the games.
|
Mind-body activities | Fitness-based activities |
Wii Fit U | Walking game and yoga | Just Dance, Zumba, and dance games (Wii Fit U minigames and Your Shape Fitness Evolved 2012) |
Xbox 360 Kinect | Your Shape Fitness Evolved 2012 (Zen energy, yoga, African rhythms, and Bollywood dance) | Your Shape Fitness Evolved 2012 (kickboxing; boot camp; and upper-, mid-, and lower-body training), Zumba, and Just Dance |
As an example of social play, participants were able to track individual and group PA achievements in a gamified way during the weekly PA coaching session by wearing the Wii Fit U fitness tracker. Under the Wii Fit U game system, each participant was able to create an anonymous Mii character and select a marathon course (eg, the London marathon) that they would like to complete. Weekly, the accumulated steps recorded by the Wii Fit U fitness tracker were converted into the distance traveled (miles), and the participants were able to see themselves advance on the marathon course once the trackers were paired with the Wii Fit U game console. At the completion line, each participant’s avatar could then choose a new outfit with the destination’s design (eg, the London tower for the London marathon). Having the ability to see each other’s weekly accomplishments allowed for further enhanced motivation through social comparison and relatedness [
For the
Participants assigned to the control group at visit 2 (
The step count monitoring intervention provided to the control group participants included a regular pedometer (
Feasibility was assessed using the enrollment rate, retention rate, intervention group attendance rate, number of technological issues and adverse events reported by the research participants, and type of games played during the intervention group sessions. On the basis of typical outcomes of feasibility studies [
The acceptability of the group AVG-based PA intervention components was measured using items adapted from Vandelanotte et al [
The PA metrics examined in our intervention included average daily steps, average minutes of light PA, and average minutes of moderate to vigorous PA (MVPA). PA metrics were objectively measured using ActiGraph, a validated research-grade 3-axis accelerometer. The wear time was 7 days at each assessment point. As continuous measurement was not feasible, a week-long sample was taken at baseline, week 6 (–1 week to +1 week), and week 12 (–1 week to +1 week). We followed the accelerometer data processing protocol published by Keadle et al [
The Short Physical Performance Battery (SPPB) was used to objectively measure physical function. The battery consists of 6 components: repeated chair sit-to-stand activity, balance test, semitandem stand, tandem stand, side-by-side stand, and 3-meter walk [
Other self-reported measures included demographics such as age, gender, race and ethnicity, education, type of cancer diagnosis, and the type of treatment the participant was receiving. Self-reported measures were collected using paper-based questionnaires. The feasibility indicators were based on an enrollment and assessment database maintained by the study research coordinator. All other assessments took place face-to-face.
Participants did not receive any monetary incentives. Rather, a water bottle, a tote bag, and a T-shirt were provided to both the intervention and control group participants as a
Data were analyzed using the SAS software (version 9.4; SAS Institute). Differences at baseline were investigated using Student
As shown in
Participant characteristics at time 0 (N=60).
Characteristic | Total | Intervention (n=30) | Control (n=30) | |||
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.31 | |||||
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0—Non-Hispanic White | 42 (70) | 21 (70) | 21 (70) |
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1—African American | 10 (17) | 3 (10) | 7 (23) |
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|
2—Hispanic | 4 (7) | 3 (10) | 1 (3) |
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|
3—Other | 4 (7) | 3 (10) | 1 (3) |
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|
|
.79 | |||||
|
0 | 7 (12) | 2 (7) | 5 (17) |
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|
|
I | 28 (47) | 14 (47) | 14 (47) |
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|
II | 14 (23) | 8 (27) | 6 (20) |
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III | 9 (15) | 5 (17) | 4 (13) |
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|
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IV | 2 (3) | 1 (3) | 1 (3) |
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.80 | |||||
|
Surgery only | 11 (18) | 5 (17) | 6 (20) |
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|
|
Surgery and chemotherapy | 9 (15) | 5 (17) | 4 (13) |
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|
|
Surgery, chemotherapy, and radiation | 24 (40) | 11 (37) | 13 (43) |
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|
Chemotherapy only | 2 (3) | 2 (7) | —b |
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|
Chemotherapy and radiation only | 2 (3) | 1 (3) | 1 (3) |
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Surgery and radiation | 12 (20) | 6 (20) | 6 (20) |
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.43 | |||||
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Off treatment | 35 (58) | 16 (53) | 19 (63) |
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On treatment | 25 (42) | 14 (47) | 11 (37) |
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.59 | |||||
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Yes | 22 (37) | 12 (40) | 10 (33) |
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No | 38 (63) | 18 (60) | 20 (67) |
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.80 | |||||
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Yes | 33 (55) | 17 (57) | 16 (53) |
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No | 27 (45) | 13 (43) | 14 (47) |
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Age (years), mean (SD; range 29-80 years) | 57.38 (10.48) | 56.10 (10.65) | 58.67 (10.33) | .35 | ||
Time since diagnosis (months), mean (SD) | 24.10 (35.83) | 25.53 (39.14) | 22.67 (25.62) | .74 | ||
BMI (kg/m2), mean (SD) | 30.62 7.46) | 29.44 (6.24) | 31.79 (8.46) | .22 |
a
bNo participants from the control group were in this category.
The enrollment rate was 55.9% (66/118 eligible participants provided consent). In the intervention group, 13% (4/30) of the participants dropped out compared with 27% (8/30) of the participants in the control group (
Of the 26 Wii Fit U game-based pedometers, 3 (12%) were damaged (eg, water damage) or lost. We were able to set up the game consoles in a small conference room (
Room setup.
Acceptability of the Pink Warrior intervention (time 2; N=26).
Item | Value, mean (SD) |
Liked the Pink Warrior program | 5.0 (0.2) |
Appropriate activities | 4.8 (0.4) |
Program helped set reasonable goals | 4.8 (0.5) |
Contents were relevant | 4.8 (0.4) |
Program was worth my time and effort | 5.0 (0.2) |
Liked the contents presented (manual) | 4.8 (0.5) |
Liked the group setting | 4.7 (0.6) |
Liked the AVGa portion | 4.8 (0.5) |
Liked the cancer survivorship topics | 4.8 (0.4) |
Like the program length | 4.4 (0.9) |
I would continue to participate | 4.6 (0.7) |
aAVG: active video game.
The PA and objective physical function measurement results for the intervention and control groups are shown in
Analysis of covariance models controlling for baseline values of the dependent variable and any baseline-intervention interaction are shown in
Physiological effects of the intervention—mean of differences between baseline and final assessment for the intervention and control groups.
Variable | Intervention | Control | Effect size (between-group differences), Cohen |
||||
|
Mean of difference (SD)a | Mean of difference (SD) |
|
||||
Average grip strength | −0.094 (3.047) | .87 | 0.568 (1.826) | .10 | 0.26 (−0.25 to 0.77) | ||
Gait speed | 0.109 (0.194) | .004 | 0.030 (0.131) | .23 | 0.48 (−0.03 to 0.99) | ||
Total SPPBc score | 0.653 (0.857) | <.001 | 0.421 (1.012) | .03 | 0.25 (−0.26 to 0.75) | ||
Steps | 1556.200 (2614.8) | .003 | −22.700 (1639.300) | .94 | 0.72 (0.20 to 1.24) | ||
Light PAd | 13.322 (80.05) | .37 | −10.687 (63.625) | .37 | 0.33 (−0.18 to 0.84) | ||
MVPAe | 11.988 (18.994) | .002 | 0.999 (10.3444) | .60 | 0.72 (0.19 to 1.24) |
aFinal assessment (time 2) – baseline assessment (time 0).
b
cSPPB: Short Physical Performance Battery.
dPA: physical activity.
eMVPA: moderate to vigorous PA.
Analysis of covariance results.
Variable | Week 0 | Group or intervention status | |||
|
|||||
Average grip strength | .806 (0.733 to 0.878) | <.001 | −0.138 (−0.676 to 0.400) | .80 | |
Gait speed | .838 (0.696 to 0.980) | <.001 | .118 (0.079 to 0.157) | .004 | |
Total SPPBb score | .515 (0.428 to 0.601) | <.001 | .470 (0.299 to 0.642) | .008 | |
Steps | .915 (0.688 to 1.142) | .002 | 1621.637 (1063.480 to 2179.794) | .005 | |
Light PAc | .899 (0.723 to 1.075) | <.001 | 21.014 (2.130 to 39.897) | .27 | |
MVPAd | .414 (0.166 to 0.661) | .10 | 11.235 (7.672 to 14.799) | .003 |
aAdjusted for baseline treatment interaction.
bSPPB: Short Physical Performance Battery.
cPA: physical activity.
dMVPA: moderate to vigorous PA.
The aims of this study were to (1) describe the feasibility and acceptability of a clinic-based multicomponent PA intervention (
As previous AVG-based interventions in survivors of breast cancer did not specifically evaluate the feasibility and acceptability of the interventions, we compared our findings with other PA interventions conducted in survivors of breast cancer. Overall, our feasibility findings fall within the range of accepted values for PA interventions conducted in survivors of breast cancer [
In addition to its feasibility, the results of our AVG-based intervention indicated acceptability. The mean acceptability score of >4 is consistent with other exergame-based PA interventions [
Our PA outcomes indicate that the AVG-based intervention benefited the participants. The increase in average number of steps per day among the intervention participants was similar to that published by Sajid et al [
The changes in the physical function outcomes among our PA intervention group are also promising. The intervention participants showed an increase in SPPB score (+0.653 in SPPB score) at the end of the intervention, whereas the Wii intervention group in the study by Sajid et al [
Our phase 1b pilot randomized controlled trial had several strengths. First, it involved an innovative intervention design that paired group-based AVGs with PA behavioral coaching to promote PA behavior among survivors of breast cancer. We systematically designed the intervention by aligning the intervention components with behavior change methods and theoretical constructs. Previous studies that used AVGs in survivors of breast cancer and other survivors of cancer primarily focused on the reduction of functional impairment; thus, their focus was not on promoting the adoption of PA behavior [
However, our study also had several limitations that are associated with the study design. First, this was a pilot study with a small sample size. Therefore, we were not fully powered to detect statistically significant differences in the participants’ outcomes or the long-term maintenance of PA behavior and physical function. Thus, our focus was on evaluating the effect size of the main outcome measures, which will provide the effect estimates needed to design a larger trial. Despite the small sample size, our AVG-based PA intervention produced moderate effect sizes and clinically important changes, which indicate that a larger-sample trial is worthwhile. Second, the pilot intervention was designed to test the feasibility and acceptability of the full intervention. The focus was on developing the most efficacious multicomponent program rather than on evaluating the impact of specific intervention components. Therefore, we were not able to determine the feasibility, acceptability, or effects of the individual portions of the intervention. Given that we found moderate effect sizes and clinically important changes in PA and physical functioning outcomes, a factorial-designed efficacy trial will be considered for a larger trial to determine the mechanisms of action of the intervention’s individual portions. Third, there was a difference in the number of group sessions offered to the control and intervention participants. This is because participants assigned to the control group received the standard of care provided by the study clinic plus a step count monitoring intervention. The highly advertised monthly breast cancer support group was a part of the study clinic’s standard of care. The differences in the number of sessions could potentially affect the differences in outcomes. Even so, the control group participants were provided with a step count monitoring intervention in addition to the standard of care to allow for activity tracking. A systematic review and meta-analysis found that similar interventions have also produced short- and long-term increases in steps. Therefore, the moderate effect sizes and clinically important changes found in our study would still be considered valid. Fourth, our
In summary, our results suggest that a clinic-based multicomponent PA intervention that combines AVG group play, group PA behavioral coaching, and breast cancer support (eg, survivorship navigation) is feasible and acceptable for middle-aged survivors of breast cancer on and off treatment. Given our results, the use of AVGs combined with manualized PA behavioral coaching can potentially be a scalable and promising strategy that can be integrated into existing breast cancer support groups to promote PA in survivors of breast cancer. Future studies are needed to understand how to efficiently integrate AVGs and PA behavioral coaching into existing breast cancer support groups. Through such integration, we will then be able to increase reach and deliver an evidence-based PA intervention to promote PA and enhance physical function. In addition, we need to better understand how and why AVGs help increase PA and physical function by comparing a group that includes AVGs with PA coaching and survivorship navigation with a group that only has PA coaching and survivorship navigation.
Summary of theoretical constructs, behavior change methods, and intervention components.
Models for imputation of missing data.
Examples of postintervention feedback.
CONSORT-eHEALTH checklist (V 1.6.1).
American Cancer Society
Active Living After Cancer
active video game
Consolidated Standards of Reporting Trials
moderate to vigorous physical activity
National Coalition for Cancer Survivorship
physical activity
quality of life
self-determination theory
Short Physical Performance Battery
University of Texas Medical Branch
This study was internally funded by the President’s Cabinet Award at University of Texas Medical Branch (UTMB). Additional salary support was provided by the Cancer Prevention Research Institute of Texas (RP140020 and RP170668); the National Institute on Disability, Independent Living, and Rehabilitation Research (90AR5009); a Mentored Research Scholar Grant in Applied and Clinical Research (MRSG-14-165-01-CPPB) from the American Cancer Society; the American Heart Association (13BGIA17110021 and 16PRE27090012); the National Institute of Child Health and Human Development (National Center for Medical Rehabilitation Research), the National Institute for Neurological Disorders and Stroke, and the National Institute of Biomedical Imaging and Bioengineering (P2CHD065702); the Claude D. Pepper Older Americans Independence Center (P30AG024832); the National Institute on Aging (1R01AG064092); the Center for Energy Balance in Cancer Prevention and Survivorship, Duncan Family Institute for Cancer Prevention and Risk Assessment; and the MD Anderson Cancer Center Support Grant (CA016672). Editorial support was provided by Bryan Tutt, Scientific Editor, Research Medical Library. The authors would also like to thank the following individuals for their assistance with participant recruitment, data collection, data analysis, and manuscript editing: Jason Bentley, PhD, MS (UTMB); V Suzanne Klimberg, MD, PhD (UTMB); Julie Park, MD (UTMB); Sandra S Hatch, MD (MD Anderson and UTMB); Rohit Venkatesan, MD (MD Anderson and UTMB); Issam Alawin, MD (Utica Park Clinic); Eloisa Martinez, BS (UTMB); Alaina Teague, MS, RD (UTMB); and Madison Walker, BS (UTMB).
None declared.