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Pilot study of a structured aerobic exercise program for Hispanic women during treatment for early-stage breast cancer.

While the risk for developing breast cancer may vary by age, lifestyle, and environmental and genetic factors, no woman is risk-free. About 182,460 women in the United States experienced invasive breast cancer in 2008, and about 40,480 women died from the disease. Right now, about 2.5 million breast cancer survivors live in the United States (American Cancer Society [ACS], 2008b).

Breast cancer is the leading cause of cancer death in Hispanic women (ACS, 2008a); population-based studies also show that they are more likely to be diagnosed at a later stage than non-Hispanic White women (Tammemagi, 2007). Epidemiologic studies have reported a rising rate of breast cancer diagnosis for Hispanic women (McNeil, 2006) perhaps due in part to the growing Hispanic population (Americans, 2005). Quality of life (QOL) also may be threatened more intensely among Hispanic women because they are diagnosed at a later stage, and more likely to undergo intense therapy and suffer the side effects of that therapy (Buki et al., 2008).

Whenever breast cancer is diagnosed, improved adjuvant therapy regimens and better therapy for recurrent disease increase survival and life span (Carlson et al., 2006; Chlebowski et al., 2006). Treatment is effective, but survival comes with a cost. Side effects plague many women during treatment. The National Cancer Institute is committed strongly to eliminating such suffering due to cancer and to improving treatment, thus reducing cancer-related health disparities such as those that exist in the Hispanic population (Thomas, Benjamin, Almario, & Lathan, 2006).

To our knowledge, a community-based program for a primarily Hispanic population during breast cancer treatment has not been conducted with collaboration of nurses, physicians, physical therapist, and community health club facility. The purpose of the current study was to evaluate the feasibility of a structured exercise intervention during treatment in a predominately Hispanic population of women.

Theoretical and Scientific Background

A comprehensive literature review of women with breast cancer who are overweight or gain weight after diagnosis found that they were at greater risk for breast cancer recurrence and death than lighter women (Carmichael & Bates, 2004; Harvie, Hooper, & Howell, 2003; Stephenson & Rose, 2003; Wenten, Gilliland, Baumgartner, & Samet, 2002). Obesity also was found to be associated with hormonal profiles likely to stimulate breast cancer growth (Slattery et al., 2007). Several authors noted that exercise reduces the perception of cancer treatment side effects and possibly reduces the chance of recurrence (perhaps indirectly through decreasing obesity) (Carmichael & Bates, 2004; Collins, Nash, Round, & Newman, 2004). Turner, Hayes, and Reul-Hirche (2004) proposed that providing a supervised, structured exercise program, and health care provider monitoring within that program might improve participation in the program. The majority of research into exercise after breast cancer diagnosis has not looked at sustaining the exercise as a lifestyle in Hispanic women.

This investigation is based on sustaining a wellness-oriented framework, the transtheoretical model (TTM) of behavioral change. This model proposes that people experience behavior change as processes unfolding over time (Prochaska, Redding, & Evers, 1997). The TTM first was used to address cessation of negative health behaviors, such as smoking, and also has been used for the acquisition of positive health behaviors, such as breast cancer screening and exercise in breast cancer survivors (Lipkus, Rimer, & Strigo, 1996; Ott et al., 2004). The TTM of change process proposes that individuals progress through a series of five stages (Glanz, Rimer, & Lewis, 2002). In the first stage of pre-contemplation, people do not intend to take action in the foreseeable future, usually measured as in the next 6 months. In the second stage, known as contemplation, people intend to change in the next 6 months. Individuals are more aware of the benefits of changing, but they also are aware of the drawbacks. Ambivalence about changing can keep people stuck in this stage for long periods of time. The preparation stage occurs when individuals plan to start a new activity in the next month. These individuals have had some significant change in their lives in the past year. Women undergoing breast cancer treatment would be in a situation to begin an action-oriented program, such as the structured exercise program. According to the TTM, people reach the action stage when they have made observable and significant exercise lifestyle modifications for 6 months (Prochaska et al., 1997). The women in this study who participated previously in weight training or a type of high-impact exercise as a lifestyle were in the maintenance stage of the TTM, and they would not be followed in this study because they would already have an established routine.

Fatigue. The most prominent side effects during the first year after breast cancer surgery are fatigue and emotional distress (Ashing-Giwa, Padilla, Bohorquez, Tejero, & Garcia, 2006). The fatigue experienced by persons with cancer is different from the usual tiredness experienced by healthy people. Patients experience physical, emotional, and mental exhaustion; have less desire to do normal activities, think, or concentrate; and may complain of a feeling of heaviness in the extremities (Payne, Piper, Rabinowitz, & Zimmerman, 2006; Piper et al., 1998). Turner and colleagues (2004) conducted a pilot study of a mixed-type, moderate-intensity exercise program in a group format and found this type of program acceptable to women following breast cancer treatment. Their program demonstrated the potential to reduce fatigue and improve quality of life, without exacerbating or precipitating lymphedema.

Weight gain. Several researchers reported that weight gain is associated with breast cancer treatment. A recent study (Harvie, Campbell, Baildam, & Howell, 2004) of women who received adjuvant chemotherapy found that the women had a greater resting energy expenditure (REE) compared with healthy subjects (n=21) [100.5 +/- 8.0% (p=0.05)]. REE declined by 3% during adjuvant chemotherapy (p<0.05). No significant changes occurred in dietary intake or physical activity over the year. The authors speculated that treatment with adjuvant chemotherapy causes body fat gain related to reduced energy expenditure, as well as the failure of women to reduce their energy intake to compensate for the decline in energy requirements during treatment and the 6-month recovery period. Because women treated for breast cancer have a higher risk for weight gain (Wilmoth, Coleman, Smith, & Davis, 2004) and decreased activity levels, they apparently would benefit from a safe exercise program during recovery.

Fasting blood glucose. Several prospective observational studies have suggested that elevated circulating glucose and insulin growth factor-1 (IGF-1) levels are associated with an increased risk of cancer and cancer recurrence (Fairey et al., 2003; Sandhu, Gibson, Heald, Dunger, & Wareham, 2004). These observations may provide a potential mechanism through which factors such as obesity and elevated levels of insulin and glucose may operate. A recent study (Sandhu et al., 2004) examined metabolic and anthropometric influences on circulating levels of IGF-1, insulin-like growth factor-binding protein-1 (IGFBP-1), and the IGF-1:IGFBP-1 ratio in a middle-aged population of 349 men and 492 women. Authors found that low IGFBP-1 levels and an increased IGF-1:IGFBP-1 ratio were associated strongly with increased levels of insulin and glucose as well as increased body mass index in men and women. Exercise, weight gain, glucose, and body composition were selected for this investigation because knowledge regarding the relationship between physical activity and these parameters is crucial to the development of interventions to improve the QOL and perhaps reduce of recurrence rates in breast cancer survivors.

Methods

This mixed methods (qualitative and quantitative) pilot study was conducted to evaluate the safety and feasibility of a community-based structured aerobic exercise program for Hispanic women during treatment for early-stage breast cancer (Tashakkori & Teddlie, 2002). In this repeated measures pilot study, a longitudinal pretest, post-test quasi-experimental design was used. Measurement of dependent variables occurred at three periods: baseline at enrollment, 3 months, and 6 months. Measurement times were selected based on data indicating weight changes during and following the median time to complete chemotherapy for primary breast cancer (Harvie et al., 2004; Schwartz, 2000). During each collection of data (T1, T2, and T3), the investigators reviewed the questionnaire data for completeness. One week prior to T2 and T3 data collection, participants were contacted by phone to schedule the data collection visits at the participants' convenience. The variability in the measured change in the glucose, fatigue perception, and other side effects from the initial assessment was critical to the successful design and plan for a subsequent major study. Data were collected by interview to provide insight into the process by which exercise is adopted as a lifestyle activity. Standardized instruments including the Side Effects Burden Scale (Longman, Braden, & Mishel, 1999), Revised Piper Fatigue Scale (Piper et al., 1998), and a physical therapy assessment, which included the 5-Minute Walk Test, strength and range of motion testing, and Penn Shoulder Score were used to quantify the level and type of side effects patients were experiencing due to breast cancer treatment.

Participants

After the protocol was approved by the institutional review board and the San Antonio Cancer Institute Board, a purposeful sample of 15 women being treated for stage I or II breast cancer was enrolled. Participants in this study were a convenience sample recruited from patients who met the eligibility criteria at the time of their outpatient appointments with the Cancer Therapy and Research Center staff doctors. To be eligible for the study, participants had to be age 34 or older, have first-time diagnoses of stage I or II breast cancer, had undergone breast cancer surgery (mastectomy or breast-conserving), and either were receiving chemotherapy or had completed chemotherapy in the past 6 months, and had medical clearance from their primary care or oncology physician. Exclusion criteria included medical conditions not safe for exercise programs and women who already participated regularly in exercise. The sample was predominately Hispanic (13 of 15 women), and this analysis was completed to reflect only Hispanic women to support future studies tailored to Hispanic women.

At the first meeting, consenting participants were measured and weighed, and completed tests regarding side effect burden and fatigue. They were instructed to make an appointment with a physical therapist, and a community health club location for exercise was selected.

Procedure

All participants were given a sports outlet gift card to purchase new walking shoes for good foot support during exercise and a 6-month membership to the community health club. Instruction and evaluation of exercise results by a physical therapist certified to work with patients with breast cancer was donated for the study.

Of the initial 15 participants recruited, two were not Hispanic and five did not go to the community health club facility. The eight women available for interview regarding their exercise experiences were interviewed face-to-face using open-ended questions. The interview used a guide designed to capture experiences, subjective feelings about health status, and motivators or barriers to exercise. All interviews began with a general request: "Tell me about exercise you have done in the past to improve your health." After this question, participants were encouraged to describe their exercise routines (e.g., "What kind of program?" or "What did you do?") and factors affecting ability and motivation to exercise currently (e.g., "What are some things that help/prevent you to exercise?" "Do you think exercise will help you feel better?" and "Do you want to lose weight?"). Interviews were audio taped, transcribed verbatim, augmented with field notes, and analyzed using the content analysis method.

Measurement

Baseline assessment scales were used to measure factors expected to influence exercise activity and demographic data (e.g., fatigue and side effects). Data also included hip and waist measurements (using a Sportline[R] non-stretchable measure tape), weight and height (using a wall-mounted Tanita scale), percent body fat, and body mass index (BMI) (using a Body Logic[TM] instrument). The next fasting glucose level was obtained from the chart after participation was initiated. A physical therapist assessed each participant's strength and limitations before exercise began. For example, if remedial therapy for frozen shoulder was deemed necessary, the physical therapist worked with the participant before medical release was given to exercise in the community health club. The assessment by the physical therapist included the 5-Minute Walk Test, strength and range of motion testing, and Penn Shoulder Score.

The research intervention consisted of exercising three times a week for 1 hour. The goal was to continue for 6 months. The exercise parameters were designed by the physical therapist, who estimated an hour-long session would burn approximately 132 calories for a 150-pound, 53-year-old woman with a height of 5 feet 4 inches. Exercises were designed to get the participants' heart rate to an optimal rate for calorie burning. Participants were taught how to monitor their own heart rate. They also received a list of indicators to postpone exercise or to stop exercising if they experienced any of the symptoms on the list, including fever, low blood counts, headache, or any other new or unusual discomfort. The exercises involved 10 minutes of warm-up exercises, 30 minutes of resistance training to improve muscle tone (15 minutes each upper and lower body), 20 minutes of brisk walking to improve heart strength, and 10 minutes of cool down.

Instruments

The Side Effects Burden Scale (SEBS) (Longman et al., 1999) was developed to measure specific side effects, such as nausea, change in appetite, difficulty sleeping, pain, fatigue, changes in bowel patterns, difficulty concentrating, changes in appearance, difficulty breathing, skin changes, arm weakness or swelling, hair loss, depression, hot flashes, and weight gain. Researchers reported the scale's predictive and construct validity in a study among women (n=307) being treated for breast cancer in all stages (p<0.05 correlations consistent with theory predicted relationships) (Longman et al., 1996). In a subsequent study by Braden (2002), the SEBS also had an internal alpha reliability of 0.91 in both the total sample (n=372) and in the Hispanic subset (n=184).

The revised version of the Revised Piper Fatigue Scale (PFS) (Piper et al., 1998) consists of 22 items and four subscales: behavioral/severity (6 items), affective meaning (5 items), sensory (5 items), and cognitive/mood (6 items). Standardized alpha for the entire scale (n=22 items) was 0.97, indicating some redundancy still may exist among the items (Harvie et al., 2004).

Analysis

The mixed methods analysis began by analyzing data within method. The quantitative analysis included scoring the PFS and the SEBS questionnaires before examining demographic and clinical characteristics distributions. Program compliance and changes in physical effects were examined. The qualitative analysis included reviewing all transcripts and field notes, coding behaviors, and identifying expressions that related to exercise.

The researchers used descriptive statistics to tabulate numbers and severity of side effects. Side effects present at the time of each data collection were rank ordered, as were specific side-effects burdens according to the most problematic side-effects burden at baseline and Time I. Researchers calculated Pearson correlation coefficients to determine the most problematic side-effects burden measures associated with weight gain, elevated glucose levels, and structured exercise program adherence.

Results

The 13 Hispanic participants ranged in age from 40 to 63 (only one over age 53). The majority (77%, n=10) of the women were married. Eight (53%) of the women were on leave from work following surgery and during chemotherapy/radiation treatment. Three (20%) returned to work during the study. Six women were full-time homemakers, one was retired, and three were caring for children less than school age. All women in this study had first-time occurrence of stage II disease; 73% experienced chemotherapy-induced menopause, 73% had not received radiation treatment, 80% had undergone either a mastectomy or a mastectomy with reconstruction (the remaining 20% were lumpectomy), and 87% had large local disease greater than 6 cm or disease in axillary nodes. One surprising finding from this study was that the physical therapist's initial assessment revealed two women had frozen shoulder. The side effect significantly correlated with the Piper Fatigue Scale was "being unable to get a decent night's sleep." See Table 1 for other study parameters and significant side effects. Researchers also examined the different therapies the women were receiving relative to exercise adherence, but did not find any patterns for distribution to be associated with type of therapies or side effects and exercise program adherence in this small sample.

Assessment of changes in weight, BMI, and percent fat found that most participants indicated they had gained weight based on self-reported initial weight (from average weight of 151.3 lbs to 165.8 lbs). This difference was not significant, although there may be a trend in this direction (t, df=9, -2.067, p=0.067). Virtually no change in weight occurred from the first to second program session (169.8 lbs to 168.7 lbs). Mean weight gain was 15 pounds, with two women requiring diabetic medication during treatment. Fasting blood glucose was lower at baseline assessment (M=116.5, SD=55.91) than at time I (M=166.2, SD=128.84), but this difference was not significant. Two participants had extreme changes in fasting blood glucose from baseline to time I (288 to 433, and 122 to 375).

Program compliance was 66% to Time I and only 7% to Time II. Virtually no change occurred in BMI (28.14 to 28.96), and only a very slight decrease in percent fat was noted (38.79% to 36.56%). Changes in physical effects for fatigue showed virtually no change from first to second session (M = 5.38 to 5.59), and ECOG Performance Status also showed virtually no change between sessions (M = 1.50 to 1.62) in this small sample.

Results of Qualitative Analysis

Employing the constant comparative approach, the investigators first read and identified potentially important concepts in over 100 pages of transcription. Grounded theory aims to generate or add to theoretical constructs that explain behaviors of women in the current social context, rather than describing every individual in the study. A process of constant comparative analysis allows each piece of data to be compared with every other piece of datum is the analysis approach used in a grounded theory research design. During a grounded theory study, interplay between analysis and data collection produces an evolving theory (Strauss & Corbin, 1998). Readers met to compare and discuss their lists of themes and corresponding text identified for the codes. After all interviews were completed and initially coded, the investigators reviewed the list of codes and their definitions, and again refined the list of themes found. Themes were compared across the exercise group, little exercise group, and no exercise group. Using the interview and field note data, and blinded to the qualitative data, one investigator classified participants according to whether or not they continued the structured program. Specifically, patients considered to be non-adhering experienced more severe side-effect symptoms and were unable or not motivated to go to the health club. Those deemed to be routinely but not completely adherent were able to perform the prescribed exercises at the health club.

Factors that impeded or facilitated adhering to the structured exercise program were identified from the qualitative data, and corroborated with the quantitative data, to determine if Hispanic women would adhere to a structured community-based exercise program exercising 1 hour three times a week for 6 months during breast cancer treatment. Measurement of dependent variables occurred at three periods: baseline at enrollment, 3 months, and 6 months. Reasons for drop-in compliance from T1 to T2 given by the women were physical limitations due to therapy, family responsibilities, lack of transportation, returning to work, and habit not adopted.

Background influences included age, physical status, habits, financial resources, family responsibilities, working full or part-time, and marital status. The following are some of the women's comments.

* "Taking care of kids takes your whole day."

* "It's really tough (to exercise) now that I'm back to work full time."

* "When I get home, I want to go out and exercise, but I'm just tired."

* "I don't have transportation."

* "Now I have the time to exercise since I retired."

Support of others was categorized as psychological and functional. Sources for support came from family, peers, employer, or the health care providers. The following are examples of the women's statements to investigators.

* "I'm meeting other people my age that are exercising."

* "It is good to see other people who are concerned about their health."

* "I need that little extra push. I kind of need that little kick in the butt."

* "If the nurses give some material or information (about exercise), it would help and that would be part of the therapy."

* "My husband is my motivator. He's just there and very supportive."

The women described their goals, commitment, ability, and self-efficacy as the positive effects. No one expressed concern that exercise would be harmful or an undesirable activity.

[FIGURE 1 OMITTED]

* "Exercise makes me feel like I'm doing something when I feel worthless otherwise."

* "Exercise gets my blood flowing and it energizes me. I feel good as a whole person."

* "Because it helps with my recovery."

* "You're setting yourself up for so many other things to happen in your life."

Discussion

Barriers to increasing exercise. Exercise is a behavior that is difficult to adapt and maintain, especially among older Hispanic women in the south Texas area (Gonzales & Keller, 2004). Evidence showed that a structured program with monitoring, companionship, and social rewards might increase the chances of women continuing a regular exercise program (Ott et al., 2004). Coon and Coleman (2004) explored exercise decisions within the context of patients with multiple myeloma and transplant implementing a home-based exercise program. A factor that influenced exercise was the belief that by exercising, they would honor a commitment to take care of their health. The side effects of surgery, radiation, and chemotherapy were categorized as intrinsic barriers, while weather, travel, and employment were either facilitators or barriers in this analysis. For example, two women were discovered to have frozen shoulder and required therapy before they could perform an exercise routine. Other problems included fatigue and nausea from chemotherapy and skin irritations from radiation. See Figure 1 for a schematic of the factors influencing adherence to the exercise program.

Mitigating barriers to exercise. Because the focus on improvement of health is paramount for women during treatment for stage I and II breast cancer, adoption of exercise as a lifestyle is a logical step. For the current study researchers anticipated that women may feel self-conscious going to a community health club and included this on the consent. Three interviewed women indicated that although everyone (both staff and peers) at the health club was helpful and supportive, they would prefer to exercise in a place that was just for women. Consequently, it is important to develop and offer many different types of programs to allow breast cancer survivors to choose which best fits their lifestyle.

Conclusions

This pilot study suggested that Hispanic women may benefit from a structured intervention during breast cancer treatment. Adopting or maintaining an exercise program is challenging for all breast cancer survivors. Hispanic women are more likely to exercise when a structured exercise program is offered with physician approval and nursing intervention. The women in this sample mentioned appearance, social support, feeling better as soon as possible, and learning to focus on themselves as reasons they chose to exercise. The information can be used to inform a larger study or program for exercise intervention.

Limitations

Data are observational within this small sample. Threats to internal validity include the possibility that inaccurate recall or social desirability influenced survey question answers. Administration mode of the survey instruments also could have been slightly different because each woman was given the survey on a one-to-one basis. An additional source for reliability variation could be due to the differences in the participants' characteristics unrelated to adherence to exercise program. The TTM used for testing outcome criteria of adherence to an exercise program does not include the full range of influences responsible for exercise activity in women being treated for breast cancer. Future research to optimize health among women being treated for breast cancer could test models competitively to determine which would inform practice evidence the best. This study found that social, physical, and psychological factors influenced women's exercise adaptation.

Nursing Implications

Providing a structured program appears to facilitate recovery from cancer and the side effects of therapy. This pilot study found that Hispanic women had some difficulty setting aside the time to devote to a structured exercise program that required about 2 hours three times a week. In the future, it will be important to develop an intervention to help Hispanic women realize life after cancer is complex (Young-McCaughan, 2006). When the goal to implement an exercise program is part of breast cancer therapy, extra attention is provided to the expected side effects, such as fatigue, nausea, frozen shoulder, elevated glucose, and weight gain. Nurses can intervene to mitigate these side effects and improve the ability of their patients to exercise vigorously enough to reap the benefits associated with increased cardiovascular health.

More studies need to be conducted among Hispanic women being treated for and surviving breast cancer to test the construct validity of the stages of the TTM. This study was too small to test the stages of change and the constructs of the TTM, but the information gained about Hispanic women will be valuable to guide more specifically tailored interventions in the future.

Acknowledgments: The authors gratefully acknowledge the contribution of Wendy Crabbe and Andrea Solorio for their assistance with recruitment for this study.

Note: The authors and all MEDSURG Nursing Editorial Board members reported no actual or potential conflict of interest in relation to this continuing nursing education article.

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Barbara Owens, PhD, RN, OCN, is a Clinical Assistant Professor, Department of Acute Nursing, University of Texas Health Science Center, School of Nursing, San Antonio, TX.

Mary Jackson, MSN, RN, OCN, is Director, Wellness Program and Patient and Family Services, Cancer Therapy and Research Center at The UT Health Science Center, San Antonio, TX.

Andrea Berndt, PhD, is a Faculty Member and Statistician, University of Texas Health Science Center, School of Nursing, San Antonio, TX.
Table 1. Correlations Between Participants' Age, Fasting Blood
Glucose, Weight Gain, and Reported Side Effects

                           Nausea         Fatigue        Dyspnea

Age                                    r = 0.556 *
Fasting blood glucose   r = -0.728 *   r = -0.674 *    r = -0.728 *
Weight gain             r = -0.879 *   r = -0.768 **   r = -0.879 *

                        Breast Skin
                          Changes        Thinking      Hot Flashes

Age                                    r = 0.545 *     r = 0.656 *
Fasting blood glucose   r = -0.824 **
Weight gain                            r = -0.771 **

                          Appetite
                            Loss

Age
Fasting blood glucose
Weight gain             r = -0.744 *

Note: Pearson's r was used to determine relationships.
* p = 0.05 level (two-tailed). ** p = 0.01 level (two-tailed).
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Title Annotation:CNE SERIES
Author:Owens, Barbara; Jackson, Mary; Berndt, Andrea
Publication:MedSurg Nursing
Article Type:Report
Date:Jan 1, 2009
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