Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors

Gynecologic Oncology 142 (2016) 304–310

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Feasibility of a physical activity intervention for obese, socioculturally diverse endometrial cancer survivors☆ Amerigo Rossi a,b,⁎, Carol Ewing Garber b, Monica Ortiz c, Viswanathan Shankar d, Gary L. Goldberg e,f, Nicole S. Nevadunsky e,f a

Division of Athletic Training, Health and Exercise Science, Long Island University Brooklyn, 1 University Plaza, HS 311a, Brooklyn, NY 11238, USA Department of Biobehavioral Sciences, Teachers College Columbia University, 525 West 120th Street, Box 93, New York, NY 10027, USA Department of Health & Nutrition Sciences, Brooklyn College, 2900 Bedford Avenue, Brooklyn, NY 11210, USA d Department of Epidemiology & Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue Bronx, NY 10461, USA e Department of Obstetrics & Gynecology and Women's Health, Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467, USA f Albert Einstein Cancer Center, Albert Einstein College of Medicine, 1300 Morris Park Avenue Bronx, NY 10461, USA b c

H I G H L I G H T S • • • •

A physical activity intervention is feasible for diverse, obese cancer survivors. Waist circumference declined by over 5 cm in 12 weeks. There was a clinically meaningful increase in quality of life scores. Better recruitment strategies are needed to increase intervention reach.

a r t i c l e

i n f o

Article history: Received 26 February 2016 Received in revised form 20 May 2016 Accepted 27 May 2016 Available online 4 June 2016 Keywords: Endometrial cancer Physical activity Quality of life Ethnicity Obesity

a b s t r a c t Purpose. Determine the feasibility of a 12-week physical activity intervention for obese, socioculturally diverse endometrial cancer survivors and to evaluate whether the intervention improves physical activity behavior, physical function, waist circumference, and quality of life. Methods. Obese endometrial cancer survivors from Bronx, NY were assigned to either a 12-week physical activity intervention of behavioral counseling, physical activity and home-based walking (n = 25), or wait-list control group (n = 15). Mixed-design ANOVA (2 groups × 2 time points) were analyzed to determine differences between the intervention and the control for the Yale Physical Activity Survey, six-minute walk test, 30-second chair stand test, waist circumference, and Functional Assessment of Cancer Therapy-Endometrial questionnaire. Data are presented as mean ± standard deviation. Results. The sample was diverse (38% non-Hispanic black, 38% Hispanic, 19% non-Hispanic white). Mean Body Mass Index was 37.3 ± 6.5 kg·m−2. Although recruitment rate was low (20% of 140 contacted), 15 of 25 participants in the intervention group attended 75–100% of scheduled sessions. Participants reported walking 118 ± 79 min/week at home. There were large effect sizes for the improvements in the six-minute walk test (22 ± 17 m vs. 1 ± 22 m, d = 1.10), waist circumference (− 5.3 ± 5.3 cm vs. 2.6 ± 6.7 cm, d = −1.32), quality of life (10 ± 12 vs. −1 ± 11, d = 0.86) and walking self-efficacy (24 ± 30% vs. 1 ± 55%, d = 0.87) compared to the control group. Conclusions. The intervention appeared feasible in this population. The results show promising effects on several outcomes that should be confirmed in a larger randomized control trial, with more robust recruitment strategies. © 2016 Elsevier Inc. All rights reserved.

☆ Supported in part by the Teachers College, Columbia University Vice President's Student Research in Diversity Grant and Dean's Grant for Student Research. ⁎ Corresponding author at: Division of Athletic Training, Health & Exercise Science, Long Island University Brooklyn, 1 University Plaza, HS 311a, Brooklyn, NY 11238, USA E-mail addresses: [email protected] (A. Rossi), [email protected] (C.E. Garber), [email protected] (M. Ortiz), [email protected] (V. Shankar), ggoldber@mentefiore.org (G.L. Goldberg), nnevadun@montefiore.org (N.S. Nevadunsky).

http://dx.doi.org/10.1016/j.ygyno.2016.05.034 0090-8258/© 2016 Elsevier Inc. All rights reserved.

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1. Introduction

2. Methods

Approximately 55,000 women were diagnosed with endometrial cancer in 2015, and the incidence rate of this cancer is projected to increase by 50% in the United States from 2010 to 2030 [1]. Although the 5-year survival rate is over 80%, the disease has a negative impact on quality of life and physical function, especially in obese survivors [2]. Middle-aged (40–64 years) endometrial cancer survivors are more likely to be sedentary, and perform 45 min less moderate-intensity physical activity per week than counterparts without cancer [3]. Furthermore, Latina and non-Hispanic black women are more likely to be sedentary than non-Hispanic white women [4]. Ethnically diverse, obese female cancer survivors have elevated risk for poor quality of life, impaired physical function, cardiovascular disease and diabetes [5, 6]. Physical activity interventions have been shown to reduce body fat and fatigue, as well as increase physical function and quality of life for cancer survivors [7]. In poorer urban environments, adherence to physical activity may be relatively low due to environmental, language and societal barriers [8], which may attenuate the effectiveness of physical activity programming in real-world settings. Tailored physical activity interventions are more effective than non-tailored interventions in the general population [9] and this is likely true in socioculturally diverse endometrial cancer survivors. The aims of this study were to 1) assess the feasibility of a 12week physical activity intervention for obese socioculturally diverse endometrial cancer survivors in Bronx, NY; 2) determine the probable effectiveness of the intervention on physical activity, waist circumference, physical function and quality of life; and 3) evaluate changes in self-efficacy, outcome expectations, social support, and self-regulation during the 12-week physical activity intervention.

The methods and procedures for this study were approved by the Institutional Review Boards of Albert Einstein College of Medicine and Teachers College Columbia University. Informed consent was obtained from all participants prior to participation in the study. 2.1. Study overview This study was a wait-list controlled trial. Recruitment began in February with a fixed intervention start date in April 2014, based upon staff and space availability. By the date of the start of the intervention, 20 participants had been enrolled, and they were randomized in a 2:1 ratio to the intervention (n = 13) and wait-list control groups (n = 7). The subsequent 8 participants enrolled after the start date were placed into the wait-list control group within the next 3 weeks. Both the intervention and control groups were assessed before (pre) and after (post) the 12week intervention period. The post assessment for the wait-list control group also served as their pre-intervention values for when they subsequently completed an identical 12-week intervention and post-testing. The results from the immediate intervention group and delayed intervention group (from wait-list control) were pooled (n = 25; Table 1). 2.2. Participants Based on a previous physical activity intervention by von Gruenigen et al. [10], which found an effect size of 1.02 for improvements in physical activity from a similar intervention, it was estimated that 12 participants per group would be needed. To account for an estimated 2 dropouts per group, 28 obese (Body Mass Index ≥ 30 kg·m− 2) English-speaking women who had been diagnosed with endometrial cancer between 6 months and 5 years prior, and without currently active

Table 1 Participant characteristics at baseline.

Age (years) Body mass index (kg m−2) Time since diagnosis (months) Stage at diagnosis Stage I Stage II Stage III Stage IV Race/ethnicity Non-Hispanic black Hispanic Non-Hispanic white Other No answer Education High school graduate or less Some college/college graduate Some graduate school or graduate degree Employment status Retired Unemployed Employed On disability Homemaker Household income b$40,000 $40,000–79,999 $80,000 or more No answer

Control (n = 15)

Intervention (n = 13)

Pooled intervention (n = 25)

65 (5) 37.8 (7.7) 31 (22)

64 (10) 36.7 (4.9) 32 (14)

64 (8) 36.6 (6.5) 32 (19)

13 (87%) 0 (0%) 2 (13%) –

11 (85%) 0 (0%) 1 (8%) 1 (8%)

22 (88%) 0 (0%) 2 (8%) 1 (4%)

6 (40%) 4 (27%) 3 (20%) – 2 (13%)

4 (31%) 6 (46%) 2 (15%) 1 (8%) –

9 (36%) 8 (32%) 5 (25%) 1 (4%) 2 (8%)

5 (36%) 3 (21%) 6 (43%)

4 (31%) 7 (54%) 2 (15%)

8 (32%) 9 (36%) 8 (32%)

10 (67%) 2 (13%) 1 (7%) 1 (7%) 1 (7%)

10 (77%) 1 (8%) 1 (8%) 1 (8%) –

17 (68%) 3 (12%) 2 (8%) 2 (8%) 1 (4%)

6 (40%) 2 (13%) 3 (21%) 4 (27%)

6 (46%) 2 (15%) 4 (29%) 1 (8%)

11 (44%) 4 (16%) 4 (16%) 5 (25%)

Data expressed as mean (standard deviation) or as frequency (percentage of group). No statistically significant differences between groups at baseline.

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disease were recruited for this study. Participants were recruited via telephone calls to potentially eligible participants provided by gynecologic oncologists at Montefiore Medical Center in Bronx, NY, and by posting flyers at surrounding cancer centers and local cancer forums. Eligible participants were cleared by their physicians for moderate- to vigorous-intensity physical activity, and agreed to attend at least weekly exercise sessions at the Albert Einstein College of Medicine fitness center. Participants were excluded if they were currently undergoing cancer treatment, had any physical or health limitation that prevented participation in moderate-intensity physical activity, or if they were already active (regular ≥3×/week moderate- to vigorous-intensity physical activity program in the previous 3 months). In order to reduce the transportation barrier to enrollment, participants who travelled via public transportation were provided with MetroCards to cover the cost of two round trips ($10) each time they attended two classes, and those who drove had parking validated ($6).

CW701, Yamax Inc, Japan) and adherence was monitored with activity logs. Pedometer step counts and walking logs were collected weekly. 2.5. Maximizing adherence Relative adherence to physical activity interventions is correlated with related improvements in physiological and psychological parameters [16]. Therefore, several measures were taken to ensure the maximum adherence. A study administrator called participants following any missed weeks to discuss barriers to continued participation. Two classes were offered weekly to increase the possibility that participants could attend at least one. Lastly, progressively more appealing incentives were distributed based on class attendance. The incentives, which included exercise shirts, dance fitness DVDs and walking sneakers, were also designed to facilitate physical activity. The total value of earned incentives was up to $145. No further incentives were offered.

2.3. Theory based physical activity intervention 2.6. Measurements The 12-week physical activity intervention was guided by Social Cognitive Theory. The practical framework of the intervention was to decrease physical activity barriers, enhance exercise self-efficacy, and ingrain implementation intentions such that participants would become independently more physically active. Other behavioral goals were to increase social support by enhancing group interaction in class and interaction with family and friends at home, improving outcome expectations by increasing self-monitoring of physical activity and the associated benefits, and increasing self-regulation through clarifying discussions about situations in which the participants are physically active or sedentary. The outline for the 12-week learning sessions was primarily based on the physical activity portion of the intervention by Stolley et al. [11] with urban African-American breast cancer survivors. An introduction to developing effective goal statements and accompanying implementation intentions was added to the topic list in order to facilitate improvement in barrier self-efficacy. The structure of the lessons in the educational materials was based on the Fine, Fit, and Fabulous Bronx initiative conducted by Bronx Health REACH [12]. The written materials for the intervention were developed using strategies developed for cancer survivors who are limited readers to maximize suitability for the participant pool [13]. 2.4. Physical activity intervention Two classes were offered per week on weekday mornings. Each class included 30 min of group counseling and 60 min of moderate- to vigorous-intensity physical activity classes, which included a 5-minute warm-up, 25 min of dance fitness, 20 min of resistance training exercises using body weight and exercise bands, and 10 min of cool-down and stretching. The exercise program was based on general recommendations from an American College of Sports Medicine (ACSM) roundtable for cancer survivors [14] and the general ACSM guidelines [15]. Participants were taught methods for increasing or decreasing the intensity of each exercise to account for individual physical improvements or impairments. Participants were also encouraged to try several of the exercises at home between classes. Ratings of perceived exertion on a scale of 6–20 were assessed to verify the intensity of the fitness classes. The classes were taught by a Hispanic black woman who was fluent in English and Spanish, and who did not conduct the baseline or followup testing. Participants were asked to walk at least 90 min per week outside of class, for a total of at least 150 min of moderate intensity physical activity. To facilitate the home-based walking program, participants were given individualized 1-, 2-, and 3- mile walking routes from their home. After initial use, the route maps were adjusted according to participant feedback. Progress was assessed using a pedometer (Yamax

2.6.1. Physical activity Physical activity was assessed using the Yale Physical Activity Survey (YPAS) [17], which was originally developed for elderly adults. The YPAS has been validated among culturally diverse older adults [18]. It also accounts for seasonal variation, which was necessary in this study due to the length of the intervention. 2.6.2. Body composition Height, post-urination weight, and waist circumference were assessed as indices of body composition. Waist circumference (WC) was measured in duplicate according to the protocol described by Lopez de la Torre et al. [19], in which the circumference is measured at the midpoint between the last rib and the iliac crest. Body Mass Index (BMI) was calculated from height and weight. 2.6.3. Physical function The 6MWT, which was administered following the guidelines of the American Thoracic Society, has been shown to be highly reliable and clinically significant among overweight and obese women [20]. At least 5 min following the completion of the 6MWT, participants completed the 30-second chair stand test, which is a reliable and valid measure of lower body strength among high functioning older adults [21]. Participants began in the seated position on a chair 43 cm in height. With their arms placed across their chest, participants fully stood up and sat down as many times as possible for 30 s. 2.6.4. Quality of life The Functional Assessment of Cancer Therapy – Endometrial Cancer (FACT-En) questionnaire was administered to assess quality of life. The FACT-En is comprised of 43 physical, social, emotional, and functional questions, which comprises the FACT-General (FACT-G), with an additional section of endometrial cancer specific concerns. The FACT questionnaires are validated measures of physical, social, emotional, and functional well-being among cancer survivors [22]. 2.6.5. Social cognitive theory variables Exercise self-efficacy was assessed using an adapted 10-item Self-Efficacy of Walking Scale [23], which asks participants how confident they are that they will be able to walk at a moderately fast pace for different time frames. A respondent who is fully confident on all of the questions would have a score of 100%. Barrier self-efficacy was assessed using the 9-item Self-Efficacy for Exercise Scale [24], which asks participants how confident they are that they would continue their physical activity when confronted with barriers such as a boring program or poor weather. Higher scores indicate greater ability to overcome obstacles. Self-regulation was assessed using the second version of the Behavioral

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Regulations in Exercise Questionnaire [25]. The total score comprises the Relative Autonomy Index, with higher scores indicating more intrinsic self-regulation. Social support was assessed using the Social Support and Exercise questionnaire [26]. Outcome expectations were assessed using the 9-item Outcome Expectations for Exercise questionnaire [27]. Higher scores indicate more positive expectations as a result of exercise. 2.6.6. Sociodemographics and health Demographic variables, including age, education level, socioeconomic status, marital status, employment status, and ethnicity, were assessed by questionnaire. Patient stage, histopathology and treatments were obtained from review of medical records. 2.6.7. Data analyses All data were analyzed using SPSS 22. Means and standard deviations were used for descriptive data. Independent samples t-tests or chi-squared tests were analyzed to assess differences between groups at baseline. Because there were no significant differences between the randomized control and placed control groups, the data were pooled to form one control group. Mixed design ANOVA (2 groups × 2 time points) were analyzed to determine differences between the intervention group and the control group for the dependent variables. Independent samples t-tests of the change scores were analyzed to determine

307

the effect sizes between groups. Alpha level for all statistical analyses was set a priori at p ≤ 0.05. 3. Results 3.1. Demographics Baseline demographic data are presented in Table 1. The sample was socioculturally diverse, middle-aged or older (range: 42–74 years) and obese (BMI range: 30–54 kg·m−2). Twenty-four patients (86%) had Stage 1 disease, three patients (11%) had Stage 3 disease, and one patient had stage 4 disease. Additionally, 23 patients had endometrioid histology (82%), 4 had serous pathology and 1 had dedifferentiated histopathology. Six of the participants had previously received chemotherapy and radiation. None of the patients were receiving chemotherapy or radiation at the time of exercise. The intervention and wait-list control groups were similar at baseline for BMI, age, ethnicity, education, physical activity, quality of life, behavioral variables, and cancer stage. 3.2. Feasibility No potential participants responded to the flyers in local cancer centers. Out of 140 potential participants contacted via telephone from lists

Fig. 1. Participant recruitment and retention.

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provided by gynecologic oncologists, 57 did not respond to repeated phone calls and/or voice mail messages. Of the 83 potential participants who were reached by phone, 43 declined, with the most common reasons being too busy (n = 19). Six women agreed to participate, but did not attend the baseline testing session and could not be reached. In all, 28 women were enrolled in the study out of 140 who were contacted (20%) (Fig. 1). For the wait-list control group (n = 15), three women did not attend the follow-up testing. Therefore the control group consisted of the remaining 12 participants. Two women who completed the follow-up chose not attend any of the subsequent exercise classes due to family commitments, such that 10 of the 15 control group participants also started the intervention. Fifteen out of the 25 participants who started the exercise classes attended one class at least 75% of the weeks, including 12 who regularly attended twice per week for a total of 86% attendance and 13 who missed 1 week or less. Four additional participants attended 50–70% of the classes. Three participants dropped out, and 3 never attended class. Of the 17 women who completed the intervention, 9 travelled via public transportation and 8 by car. There was no difference in the number of classes attended between participants who travelled via public transportation (19 ± 5 classes) or car (17 ± 4 classes). Participants reported walking 118 ± 79 min per week at home, however only 60% of the walking journals returned. Similarly, participants reported walking 5661 ± 2617 steps per day, but only 67% of the weeks were included due to participants not wearing the pedometer or missing class for data collection. Four participants (16%) dropped out due to knee pain (n = 2) and personal family issues (n = 2), and four others were lost to follow-up. The exercise classes were designed to elicit moderate- to vigorousintensity physical activity. Participants reported ratings of perceived exertion of 14.2 ± 1.1 (range: 13–16) indicating moderate- to vigorousintensity physical activity.

were no detectable group × time interaction effects for the YPAS Summary Index, although there was a small but positive effect size for the intervention group (Cohen's d = 0.33). Although there was no significant main effect of time for waist circumference, it should be noted that waist circumference decreased 5.3 ± 5.3 cm for the intervention group compared to a 2.6 ± 6.7 cm increase for the control group, indicating a large effect size (Cohen's d = −1.33). There were significant main and interaction effects for the six-minute walk test (p b 0.01). The intervention group increased their distance walked by 22.0 ± 16.7 m, compared to 1.1 ± 22.0 m for the control group (Cohen's d: 1.10). There were significant main effects of time (p = 0.05) and interaction effects (p b 0.01) for quality of life, assessed using the FACT-Endometrial. There was an increase of 10 ± 12 points for the intervention group, compared slight decrease for the control group (− 1 ± 11 points), which reflects a large effect size (Cohen's d: 0.86). There were also significant main effects (p b 0.01) and interaction effects (p = 0.02) for the FACT subscale regarding endometrial cancer specific issues. The subscale increased by 6 ± 5 points in the intervention group and 1 ± 6 points in the control group (Cohen's d: 0.95). For the behavioral variables (Table 3), there were significant effects of time for walking self-efficacy, and Relative Autonomy Index, but significant interaction effects for walking self-efficacy only (p = 0.03). Walking self-efficacy, which is scored on a scale of 0–100%, increased by 23 ± 30 percentage points in the intervention group, compared to 0 ± 15 percentage points in the control group, which corresponds to a large effects size. Furthermore, there was a large effect size for the difference in changes in outcome expectations and a small to moderate effect size for barrier self-efficacy. There were no reported adverse events from the physical activity intervention greater than normal muscle soreness. 4. Discussion

3.3. Outcomes A summary of the outcomes is presented in Table 2. When comparing the intervention group to the control group, there were no significant main effects of time for YPAS energy expenditure, which asks about physical activity during the previous week, but there was a significant main effect of time for the YPAS Summary Index (p b 0.01), which analyzes physical activity from the previous month. However, there

The primary aims of this study were to determine whether a physical activity intervention would be feasible in socioeconomically diverse endometrial cancer survivors, and secondly whether the intervention would lead to positive changes in physical activity and associated measures of health and wellness. Enrollment was relatively low, but attendance and adherence were high in the current study indicating that the intervention was feasible. The intervention led to relatively small

Table 2 Physical activity, body composition, physical function and quality of life for the control and interventions groups before and after the 12-week intervention. Control (n = 12)

Intervention (n = 17)

Main effect of time

Interaction effect

Cohen's d

5507 (2976) 63(21)

p N 0.2 p b 0.01

p N 0.2 p N 0.2

0.13 0.33

94.0 (16.9) 113.6 (12.9)

93.4 (15.7) 108.4 (11.4)

p N 0.2 p N 0.2

p N 0.2 p b 0.01

−0.32 −1.32

428 (65) 12.4 (3.2)

431 (64) 12.5 (3.2)

453 (65) 13.7 (2.7)

p b 0.01 p b 0.01

p b 0.01 p N 0.2

1.10 0.04

143 (12) 89 (10) 54 (7)

141 (14) 88 (9) 53 (8)

151 (17) 92 (12) 59 (8)

p = 0.05 p N 0.2 p b 0.01

p = 0.03 p = 0.13 p = 0.02

0.86 0.61 0.95

Baseline

Post

Baseline

Post

Physical activity YPAS EE (kcal/week) YPAS summary index

4860 (2900) 40(21)

5324 (3512) 52(25)

4663 (2307) 42(25)

Body composition Weight (kg) WC (cm)

97.1 (20.9) 111.7 (11.6)

97.4 (21.8) 114.2 (14.4)

Physical function 6MWT (m) Chair stands (reps)

427 (60) 11.2 (3.4)

Quality of life FACT-En FACT-G Endometrial subscale

143 (15) 90(10) 53 (6)

Data presented as mean (standard deviation). Note: Two participants did not complete the physical function tests due to knee pain. YPAS EE: Yale Physical Activity Survey Energy Expenditure. WC: Waist Circumference. 6MWT: Six-minute walk test. FACT-En: Functional Assessment of Cancer Therapy - Endometrial.

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Table 3 Changes in physical activity behavioral variables. Control (n = 12)

Walking self-efficacy (0–100%) Barrier self-efficacy (0−10) Self-determination (RAI) Outcome expectations (1–5) Social support (20−100)

Intervention (n = 17)

Baseline

Post

Baseline

Post

43 (33) 5.3 (2.5) 7.3 (6.0) 3.5 (0.8) 34.8 (12.6)

44 (35) 5.0 (3.1) 9.8 (6.7) 3.3 (0.8) 40.2 (14.1)

40 (31) 5.5 (2.5) 9.9 (7.5) 3.4 (0.7) 37.7 (14.9)

63 (31) 6.5 (2.5) 13.5 (5.7) 3.7 (0.6) 36.8 (13.0)

Main effect of time

Interaction effect

Cohen's d

p = 0.02 p N 0.2 p b 0.01 p N 0.2 p N 0.2

p = 0.03 p N 0.2 p N 0.2 p b 0.01 p N 0.2

0.87 0.40 0.25 1.09 −0.41

Data presented as mean (standard deviation). RAI: Relative Autonomy Index.

improvement in self-reported physical activity, and large improvements in quality of life, waist circumference, and walking endurance. These changes were accompanied by a large improvement in walking self-efficacy. All participants in the current study were found via contact lists provided by gynecologic oncologists; no participants responded to posted flyers. Additionally, study administrators were unable to contact 57 out of 140 patients who were telephoned. Therefore, future recruitment efforts in similar populations should focus on on-site recruitment to maximize the reach of the study. Overall, less than 20% of potential participants were eventually enrolled in the study. This level of participation is similar to previous studies of endometrial cancer survivors (16–29%) [10,28–30], although the dropout rate in the current study was higher than previously observed (7–22%) [10,28,30,31]. Adherence in the current study, defined as attending at least one class per week for 75% of the weeks, was 60%. In other studies with predominately non-Hispanic white endometrial cancer survivors, Donnelly et al. [28] found that 58% of participants adhered to the program 2/3 of the time, and von Gruenigen et al. [10,30] reported that participants attended between 73–84% of classes over 6 months. The enrollment, dropout and attendance data from the current study are within the range of past studies, indicating that this physical activity intervention was feasible for obese, socioculturally diverse endometrial cancer survivors. The current study is the first for endometrial cancer survivors to show a significant improvement in global quality of life compared to a control group [32]. The primary subscale change observed in the current study was for endometrial cancer specific issues (6 point improvement). While this is apparently meaningful, with a large effect size, it is difficult to compare these findings due to the fact that the FACT-Endometrial is seldom used. The mean improvement in the FACT-G score, which is more widely utilized, was 5 points higher in the intervention group than the control group, which is considered a clinically meaningful improvement [33]. Waist circumference, a measure of visceral adiposity, decreased in the current study, whereas body weight was reduced only margin compared to the control group. Although muscle mass was not assessed in the current study, it is likely that body fat decreased and muscle mass increased in the participants, as has been found in other physical activity interventions for breast cancer survivors [34], and may be accompanied by improvements in cardiovascular risk biomarkers [35]. Since waist circumference has been shown to be a better predictor of cardiovascular disease than BMI among women [36], these findings suggest that a 12week physical activity intervention can decrease cardiovascular disease risk among obese endometrial cancer survivors. Participants in the intervention group also had significantly greater improvements in the six-minute walk test, indicating improved physical function. The only other comparable study to have assessed physical function [28] among gynecological cancer survivors did not observe any improvement in the 12-minute walk test. Since this physical activity intervention included a walking component as well as a body-weight training component, it was surprising the 6-minute walk test improved for the intervention group, but the 30-second chair stand did not. Previous studies with this population have found that walking is the most

preferred source of physical activity [37], and the participants in the current study also reported walking nearly 2 h per week outside of the fitness class. It is likely that the increased walking associated with the physical activity intervention led to greater improvements than the in-class activities, which only comprised roughly 20 min per class session. As expected, the participants in this study were socioculturally diverse, compared to previous similar studies, which have utilized primarily (75–100%) non-Hispanic white samples [10,28–31]. Selfreported physical activity did not increase in the intervention group compared to the control group in the current study. Conversely, both physical activity interventions for endometrial cancer survivors by von Gruenigen et al. [10,30] reported an increase in self-reported physical activity using the Godin Leisure Time Index. However, among other randomized, controlled, theory-based physical activity interventions for obese female cancer survivors (any site), physical activity did not increase significantly, and the estimated effect sizes were 0.16–0.28 [38, 39]. Print-only interventions do not have an effect on physical activity in cancer survivors [40]; therefore it is unlikely that the single pamphlet distributed to the wait-list control group participants had any effect on physical activity. Future studies should utilize objective measures such as accelerometry in order to substantiate the physical activity findings. The primary limitations of this study were small sample size with 28 total participants, and with complete pre and post data available on 17 participants. Additionally, the experimenters were not blinded which may have introduced bias into the findings. In order to reduce the potential for bias caused by unblinded experimenters, protocols were standardized for both groups. Furthermore, the waist circumference measurement was conducted twice by each rater, and by both raters whenever possible, which was in 51% of the tests (Intraclass correlation coefficient: 0.99). Self-reporting of time spent walking outside of class was 60%, making it difficult to fully assess the level of participation outside of class. 4.1. Recommendations for future interventions During the recruitment phase, no participants responded to flyers that had been posted around the Montefiore Medical Center in the Oncology offices or left with local cancer support groups. Furthermore, out of the 140 people we attempted to contact by phone, we were only able to reach 83. In this study, of the women we were able to speak with, only 34% enrolled in the study, which is a relatively low yield from our recruitment efforts. Recruitment, the subsequent randomization schedule, and adherence may have been hindered by participants' travel difficulty. Although the Bronx is only one part of New York City, some participants had to take multiple busses and/or subway rides to the testing/training location, traveling over an hour. Future research should focus on smaller classes, with rolling admissions, with several classes with scheduling across the day, and at multiple locations throughout an area, to increase the reach and effectiveness of the program. The instructor for the current program was a black Hispanic woman of Caribbean descent who grew up in New York City. Anecdotal reports suggest that participants were able to identify with her because of their

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shared backgrounds. The instructor reported that several of the participants confided in her about their intimate family issues, as well as endometrial cancer related issues that they had been embarrassed to discuss before the intervention. Related studies with similar populations should ensure that the intervention instructor could relate well with the study participants.

[16]

[17] [18]

5. Conclusion [19]

The relatively low enrollment in this study illustrates the difficulty of recruiting a representative sample from this population. However, the dropout rate and adherence were moderate among enrolled participants, and attendance was high among about one-half of the participants, indicating that the intervention was feasible. The outcomes for physical activity and other measures were promising, and should be confirmed with a randomized controlled trial with a larger sample size and more objective assessments. Conflict of interest statement

[20]

[21]

[22]

[23]

The authors wish to disclose that there are no conflicts of interest.

Acknowledgements

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