Randomized Controlled Trial of a Home-Based Walking Program to Reduce Moderate to Severe Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors.

BACKGROUND: In postmenopausal women diagnosed with breast cancer (BC), most BC tumors are hormone receptor positive and guidelines recommend adjuvant endocrine therapy that includes an aromatase inhibitor (AI). This study investigates the impact of a 6-week, home-based, self-directed walking program on the commonly reported side effect of AI-associated arthralgia (AIAA). MATERIALS AND METHODS: In this phase II trial, consented BC patients were randomized to walking Intervention (n = 31) or Wait List Control (WLC; n = 31). Eligibility criteria included: stage 0-III BC, on AI for at least 4 weeks, ≥3 on a 5-point scale inquiring about joint symptom intensity "at its worst," and exercising ≤150 minutes per week. Outcomes were self-reported joint symptoms and psychosocial measures. Analyses comparing Intervention and WLC groups were conducted on an intention-to-treat basis to assess intervention impact at 6 weeks (postintervention) and at 6-months follow-up. Adjusted means were calculated to assess differences in two groups. RESULTS: In our final sample (n = 62), mean age was 64 years, 74% were white, and 63% had a body mass index of 30 or higher. At postintervention, Intervention group participants reported significantly increased walking minutes per week, reduced stiffness, less difficulty with activities of daily living (ADL), and less perceived helplessness in managing joint symptoms. At 6-months follow-up (postwalking period in both Intervention and WLC), walking minutes per week had decreased significantly; however, improvements in stiffness and difficulty with ADLs were maintained. CONCLUSION: This study adds to the growing evidence base suggesting exercise as a safe alternative or adjunct to medications for the management of AIAA. IMPLICATIONS FOR PRACTICE: Breast cancer survivors whose adjuvant endocrine treatment includes an aromatase inhibitor (AI) often experience the side effect of AI-associated arthralgia (AIAA). This study investigates the impact of a 6-week, home-based, self-directed walking program in the management of AIAA. Compared with Wait List Control, women in the Intervention group reported significantly increased walking minutes per week, reduced stiffness, less difficulty with activities of daily living, and less perceived helplessness in managing joint symptoms. This study adds to the growing evidence base suggesting exercise as a safe alternative or adjunct to medications for the management of AIAA.

Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial.

BACKGROUND: Recently, we determined that in a rigorously monitored environment an intensive diet-induced weight loss of 10% combined with exercise was significantly more effective at reducing pain in men and women with symptomatic knee osteoarthritis (OA) than either intervention alone. Compared to previous long-term weight loss and exercise trials of knee OA, our intensive diet-induced weight loss and exercise intervention was twice as effective at reducing pain intensity. Whether these results can be generalized to less intensively monitored cohorts is unknown. Thus, the policy relevant and clinically important question is: Can we adapt this successful solution to a pervasive public health problem in real-world clinical and community settings? This study aims to develop a systematic, practical, cost-effective diet-induced weight loss and exercise intervention implemented in community settings and to determine its effectiveness in reducing pain and improving other clinical outcomes in persons with knee OA. METHODS/DESIGN: This is a Phase III, pragmatic, assessor-blinded, randomized controlled trial. Participants will include 820 ambulatory, community-dwelling, overweight and obese (BMI ≥ 27 kg/m2) men and women aged ≥ 50 years who meet the American College of Rheumatology clinical criteria for knee OA. The primary aim is to determine whether a community-based 18-month diet-induced weight loss and exercise intervention based on social cognitive theory and implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to a nutrition and health attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, mobility, and is cost-effective. DISCUSSION: Many physicians who treat people with knee OA have no practical means to implement weight loss and exercise treatments as recommended by numerous OA treatment guidelines. This study will establish the effectiveness of a community program that will serve as a blueprint and exemplar for clinicians and public health officials in urban and rural communities to implement a diet-induced weight loss and exercise program designed to reduce knee pain and improve other clinical outcomes in overweight and obese adults with knee OA. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02577549 October 12, 2015.

Aromatase inhibitor associated arthralgia: the importance of oncology provider-patient communication about side effects and potential management through physical activity.

PURPOSE: Breast cancer survivors on aromatase inhibitors (AI) often experience side effects of joint pain, stiffness, or achiness (arthralgia). This study presents findings from a qualitative study of survivors on an AI regarding their knowledge of potential joint pain side effects and how both AI side effects and their management through moderate physical activity could be discussed during routine visits with their oncology provider. METHODS: Qualitative data from semi-structured interviews were content analyzed for emergent themes. Descriptive statistics summarize sample characteristics. RESULTS: Our sample included 36 survivors, mean age of 67 (range 46-87); 86 % Caucasian and 70 % had education beyond high school. AI experience are as follows: 64 % anastrozole/Arimidex, 48 % letrozole/Femara, and 31 % exemestane/Aromasin. Participants expressed interest in having more information about potential joint pain side effects when the AI was prescribed so they could understand their joint symptoms when they appeared or intensified. They were relieved to learn that their joint symptoms were not unusual or "in their head." Participants would have been especially motivated to try walking as a way to manage their joint pain if physical activity had been recommended by their oncologist. CONCLUSIONS: Breast cancer survivors who are prescribed an AI as part of their adjuvant treatment want ongoing communication with their oncology provider about the potential for joint pain side effects and how these symptoms may be managed through regular physical activity. The prescription of an AI presents a "teachable moment" for oncologists to recommend and encourage their patients to engage in regular physical activity.

Evaluation of Tai Chi Program Effectiveness for People with Arthritis in the Community: A Randomized Controlled Trial.

OBJECTIVE: Evaluate effectiveness of the Arthritis Foundation Tai Chi Program for community participants with arthritis. METHODS: 343 individuals were randomized to either the intervention or wait-list control group. Performance and self-reported outcome (SRO) measures were assessed at baseline and eight weeks. At one year, SROs only were assessed. Adjusted means were determined using regression models adjusting for covariates, and effect sizes (ES) were calculated. RESULTS: Average participant age was 66 years, 87% were female, and 87% were Caucasian. Among 284 (83%) participants who returned at eight weeks, balance by reach (ES = 0.30) and helplessness, sleep, and role participation satisfaction (ES = 0.24-0.54) improved significantly; pain, fatigue, and stiffness improvement (ES = 0.15-0.23) approached significance. No change was noted in mobility, lower extremity strength, or single-leg stance balance. At one year, improvements in pain, fatigue, stiffness, helplessness, and role participation satisfaction at eight weeks were maintained; 30% continued tai chi practice. CONCLUSION: Moderate effectiveness of the Arthritis Foundation Tai Chi Program was confirmed.

Adaptation of an Evidence-Based Arthritis Program for Breast Cancer Survivors on Aromatase Inhibitor Therapy Who Experience Joint Pain.

Adding aromatase inhibitors (AIs) to adjuvant treatment of postmenopausal women with hormone-receptor-positive breast cancer significantly reduces cancer recurrence. A common side effect of AIs is noninflammatory joint pain and stiffness (arthralgia) similar to arthritis symptoms. An evidence-based walking program developed by the Arthritis Foundation - Walk With Ease (WWE) - reduces arthritis-related joint symptoms. We hypothesized that WWE may also reduce AI-associated arthralgia. However, the potential for different barriers and facilitators to physical activity for these 2 patient populations suggested a need to adapt WWE before testing it with breast cancer survivors. We conducted qualitative research with 46 breast cancer survivors to explore program modification and inform the development of materials for an adapted program (Walk With Ease-Breast Cancer). Our process parallels the National Cancer Institute's Research-Tested Intervention Programs (RTIPs) guidelines for adapting evidence-based programs for cancer populations. Findings resulted in a customized 8-page brochure to supplement existing WWE materials.

Evaluation of the Arthritis Foundation's Camine Con Gusto Program for Hispanic Adults With Arthritis.

INTRODUCTION: Camine Con Gusto (CCG) is the Hispanic version of an evidence-based walking program for people with arthritis. This study examined CCG outcomes, feasibility, tolerability, safety, and acceptability and potential tailoring. METHOD: A pre and post 6-week evaluation was conducted in Hispanic people with arthritis. Outcomes included pain, stiffness, fatigue, functional capacity, helplessness, and self-efficacy. A formative evaluation with program participants and key stakeholders explored program tailoring. RESULTS: Participants' mean age was 46.9 years, 44.4% had a high school degree or less, 2.5% were born in United States, 60.1% spoke only Spanish, and 74.7% were female. Moderate effect sizes were found: 0.50 for pain, 0.75 for fatigue, 0.49 for stiffness, 0.33 for function, 0.26 for helplessness, and 0.24 for self-efficacy. There were 285 participants recruited with an 82% 6-week retention (feasibility), no adverse events were reported (safety), and 98% reported program satisfaction (acceptability). Recommended adaptations included simpler language, more pictures and content addressing nutrition and chronic conditions, shortened materials, and inclusion of motivational strategies. CONCLUSION: CCG showed improvement in outcomes in Hispanic individuals comparable to those noted in non-Hispanic White and Black individuals with arthritis.

Feasibility and promise of a 6-week program to encourage physical activity and reduce joint symptoms among elderly breast cancer survivors on aromatase inhibitor therapy.

BACKGROUND: National guidelines suggest that women with hormone receptor positive breast cancer be considered for adjuvant endocrine treatment with an aromatase inhibitor (AI). Joint symptoms (arthralgia) are a common AI side-effect. There is a need for effective approaches to arthralgia management that enable survivors to remain on AI therapy while optimizing as pain-free a life as possible. This feasibility study investigates a 6-week self-directed walking program in a sample of elderly female breast cancer survivors on AIs reporting joint pain. INTERVENTION: Walk With Ease (WWE) goal--minimum 30 min of walking 5 days a week (150 min per week). Eligibility: age >65; Stage I-III breast cancer; ≥3 months of AI therapy; self-reported joint pain/stiffness. MEASURES: (1) walking--number of days/week and number of minutes/walk, (2) visual analog scales (VAS) for joint pain, fatigue and stiffness, and (3) arthritis self-efficacy (ASE) to manage joint pain and fatigue. STATISTICS: t-tests, correlation coefficients and effect sizes. RESULTS: Sample target of 20 was achieved--mean age 71 (65-87), 85% Caucasian, mean BMI 29. Proportion walking 150 min/week increased from 21% at baseline to 50% at 6 weeks (p < 0.001). Mean joint pain at baseline (39.7 + 26.9) decreased 10% (p = 0.63), fatigue (37.4+33.3) decreased 19% (p = 0.31), joint stiffness (46.1 + 27.2) decreased 32% (p = 0.07). CONCLUSIONS: A self-directed walking program among elderly breast cancer survivors on AI therapy significantly increased total time of walking per week over a 6 week period. Joint pain, stiffness, and fatigue also decreased, although not significantly. Testing within a larger sample is warranted.

Adaptation of the health literacy universal precautions toolkit for rheumatology and cardiology - applications for pharmacy professionals to improve self-management and outcomes in patients with chronic disease.

Over a decade of research in health literacy has provided evidence of strong links between literacy skills of patients and health outcomes. At the same time, numerous studies have yielded insight into efficacious action that health providers can take to mitigate the negative effects of limited literacy. This small study focuses on the adaptation, review and use of two new health literacy toolkits for health professionals who work with patients with two of the most prevalent chronic conditions, arthritis and cardiovascular disease. Pharmacists have a key role in communicating with patients and caregivers about various aspects of disease self-management, which frequently includes appropriate use of medications. Participating pharmacists and staff offered suggestions that helped shape revisions and reported positive experiences with brown bag events, suggestions for approaches with patients managing chronic diseases, and with concrete examples related to several medicines [such as Warfarin(©)] as well as to common problems [such as inability to afford needed medicine]. Although not yet tested in community pharmacy sites, these publically available toolkits can inform professionals and staff and offer insights for communication improvement.