Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.

BACKGROUND: Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors. METHODS: An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ2 test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ2 test and logistic regression was used for estradiol. Analysis was based on intention-to-treat. RESULTS: A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups. CONCLUSION: SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.

Long-Term Favorable Effects of Physical Exercise on Burdensome Symptoms in the OptiTrain Breast Cancer Randomized Controlled Trial.

Purpose: We evaluate longitudinal changes in symptom clusters and core burdensome symptoms in breast cancer patients who participated in the OptiTrain trial. Methods: 240 women were randomized to 16 weeks of supervised exercise (RT-HIIT or AT-HIIT) or usual care (UC) during adjuvant chemotherapy. Symptom clusters were composed using the Memorial Symptom Assessment Scale (MSAS), assessed at baseline, 16 weeks and 12 months later. Three symptom clusters were formed. Results: Three symptom clusters were identified: "emotional," "treatment-related toxicity," and "physical," with core burdensome symptoms present over time. At 16 weeks, the reported burdens of "feeling sad" (RT-HIIT vs UC: effect size [ES] = -0.69; AT-HIIT vs UC: ES = -0.56) and "feeling irritable" (ES = -0.41 RT-HIIT; ES = -0.31 AT-HIIT) were significantly lower in both intervention groups compared with UC. At 12 months, the AT-HIIT group continued to have significantly lower scores for the core burdensome symptoms "feeling sad" (ES = -0.44), "feeling irritable" (ES = -0.44), and "changes in the way food tastes" (ES = -0.53) compared with UC. No between-group differences were found for physical symptoms. Conclusion: We identified 3 symptom clusters in breast cancer patients during and after adjuvant chemotherapy, composed of "emotional," "treatment-related toxicity," and "physical" symptoms. After treatment completion up to 12 months post-baseline, patients in the physical exercise groups reported lower symptom burden scores for emotional symptoms, compared with UC. Our findings indicate a preserved and long-term beneficial effect of physical exercise on self-reported emotional well-being in chemotherapy-treated breast cancer patients.

Evaluation of the Effectiveness of a Multimodal Complementary Medicine Program for Improving the Quality of Life of Cancer Patients during Adjuvant Radiotherapy and/or Chemotherapy or Outpatient Aftercare.

OBJECTIVES: Evidence for complementary therapies as important strategies to relieve cancer treatment-associated symptoms is increasing. Mostly, these complementary therapies start at the end of adjuvant treatments, resulting in a long delay until the well-being of patients is addressed. Further, long distances between the rehabilitation center and the patients' residence hinder patients' compliance. METHODS: The multimodal outpatient LOTUS Care Cure Project (LCCP) was tested in a randomized controlled trial including patients of various cancer entities and stages while on adjuvant chemotherapy and/or radiotherapy or outpatient aftercare. The intervention group received the LCCP additionally to the conventional treatment (LCCP group, n = 50). The control group (CG) was split into 2 groups, with (CG1, n = 33) and without (CG2, n = 17) weekly talks. The primary endpoint was quality of life (QoL) after 3 months. RESULTS: In the LCCP group, QoL significantly improved after 3 months compared to CG2 (p = 0.022) but not compared to CG1. Other parameters showing a significant improvement were cognitive (p < 0.05, vs. CG1 and CG2) and social function (p < 0.05, vs. CG2). CONCLUSIONS: This pilot study describes a multimodal outpatient complementary therapy program conducted in parallel with conventional therapies and its potential to significantly improve QoL and reduce treatment-associated side effects. To substantiate these data, multicenter trials are needed.

Short term quality of life with epirubicin-fluorouracil-cyclophosphamid (FEC) and sequential epirubicin/cyclophosphamid-docetaxel (EC-DOC) chemotherapy in patients with primary breast cancer - Results from the prospective multi-center randomized ADEBAR trial.

BACKGROUND: The recommendation for adjuvant dose-dense chemotherapy in high risk primary breast cancer is heterogeneous among guidelines. Understanding the impact on QoL is thereby a crucial factor, especially if the benefit is potentially low. This study aims to assess QoL as a secondary outcome in the prospective randomized multi-center ADEBAR trial. METHODS: QoL was assessed at baseline (t1), before cycle 4 FEC and cycle 5 EC-DOC (t2), 4 weeks after chemotherapy (t3) and 6 weeks after radiation (t4) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). RESULTS: 1306 patients were enrolled into the ADEBAR trial. 675 were assigned to the FEC and 688 to the EC-DOC arm. After the beginning of treatment, global QoL dropped in both arm by 3-4 points. In the EC-DOC arm, QoL dropped further at t3 by 7 points and stayed stable in the FEC arm. 6 weeks after radiation, QoL exceeded baseline in both arms by 6-8 points. The differences between treatment arms were strongest at t3 (53.0 vs. 49.5) but did not reach clinical relevance at any point in time. Physical functioning, nausea and vomiting, fatigue and systemic therapy side effects followed with some minor exceptions similar patterns but showed higher amplitudes. CONCLUSION: In conclusion, we could not detect a clinically relevant difference between the two treatment arms in global QoL, although the results consistently show that patients on EC-DOC report worse scores during the treatment.

Beneficial Effects of Pranic Meditation on the Mental Health and Quality of Life of Breast Cancer Survivors.

BACKGROUND: Breast cancer survivors frequently present long-lasting impairments, caused either by the disease or its treatment, capable of compromising their emotional health and quality of life. Meditation appears to be a valuable complementary measure for overcoming some of these impairments. The purpose of the present investigation was to assess the effect of pranic meditation on the quality of life and mental health of breast cancer survivors. DESIGN: This study was a prospective single-arm observational study using before and after measurements. METHODS: The subjects were 75 women submitted either to breast cancer therapy or to posttherapy control who agreed to practice pranic meditation for 20 minutes, twice a day, during 8 weeks, after receiving a formal training. The quality of life of the practitioners was assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC BR-023 questionnaires, and the mental health status by the Goldberg's General Health Questionnaire. RESULTS: After 8 weeks of pranic meditation practice, the subjects showed a significant improvement of their quality of life scores that included physical (P = .0007), role (P = .01), emotional (P = .002), and social functioning (P = .004), as well as global health status (P = .005), fatigue (P < .0001), pain (P = .007), sleep disturbances (P = .01), body image (P = .001), arm symptoms (P = .007), and breast symptoms (P = .002). They also showed a reduction of the side effects of systemic therapy (P = .02) and being upset by hair loss (P = .02). Moreover, meditation was associated with improvement of the mental health parameters of the practitioners that included psychic stress (P = .001), death ideation (P = .02), performance diffidence (P = .001), psychosomatic disorders (P = .02), and severity of mental disorders (P = .0003). The extension of the meditation period from 8 to 15 weeks caused no substantial extra benefits in practitioners. CONCLUSIONS: The results of this pilot study showed that breast cancer survivors presented significant benefits related to their mental health and quality of life scores after a short period of practice of pranic meditation, consisting of simple and easy-to-learn exercises. However, because of the limitations of the study, further research is required using a more rigorous experimental design to ascertain whether pranic meditation may be an acceptable adjunct therapy for cancer patients.

Noninitiation of adjuvant chemotherapy in women with localized breast cancer: the breast cancer quality of care study.

PURPOSE: For some women, adjuvant chemotherapy for nonmetastatic breast cancer decreases recurrences and increases survival; however, patient-physician decisions regarding chemotherapy receipt can be influenced by medical and nonmedical factors. PATIENTS AND METHODS: We used a prospective cohort design and multivariate modeling to investigate factors related to noninitiation of chemotherapy among women with newly diagnosed breast cancer recruited from three US sites. We interviewed patients at baseline and during treatment on sociodemographic, tumor, and treatment decision-making factors. Patients were categorized according to National Comprehensive Cancer Network guidelines as those for whom chemotherapy was definitely indicated, clinically discretionary, or discretionary based on age greater than 70 years. RESULTS: Of 1,145 patients recruited, chemotherapy was clinically indicated for 392 patients, clinically discretionary for 459 patients, discretionary because of age for 169 patients, and not indicated for 93 patients; data were insufficient for 32 patients. Chemotherapy rates were 90% for those in whom chemotherapy was clinically indicated, 36% for those in whom it was discretionary because of clinical factors, and 19% for those in whom it was discretionary based on age greater than 70 years. Nonreceipt of chemotherapy was associated with older age, more negative beliefs about treatment efficacy, less positive beliefs about chemotherapy, and more concern about adverse effects. In the two discretionary groups, clinical predictors of worse outcome (greater tumor size, positive nodes, worse grade, and estrogen receptor- and progesterone receptor-negative status) were associated with increased chemotherapy initiation. CONCLUSION: Utilization of adjuvant chemotherapy was most common among patients who, based on clinical criteria, would most likely benefit from it, patients with more positive than negative beliefs regarding treatment efficacy, and patients with few concerns about adverse effects.

Development of decision-support intervention for Black women with breast cancer.

BACKGROUND: Adjuvant therapy improves breast cancer survival but is underutilized by Black women. Few interventions have addressed this problem. This preliminary report describes the process we used to develop a decision-support intervention for Black women eligible for adjuvant therapy. Aims were to use qualitative methods to describe factors that influence Black women's adjuvant therapy decisions, use these formative data to develop messages for a treatment decision-support intervention, and pilot test the acceptability and utility of the intervention with community members and newly diagnosed women. METHODS: Thirty-four in-depth interviews were conducted with breast cancer patients in active treatment, survivors and cancer providers to gather qualitative data. Participant ages ranged from 38 to 69 years. A cultural framework was used to analyze the data and to inform intervention messages. Most women relied on their providers for treatment recommendations. Several women reported problems communicating with providers and felt unprepared to ask questions and discuss adjuvant treatment options. Other factors related to treatment experiences were: spiritual coping, collectivism and sharing breast cancer experiences with other Black survivors. RESULTS: Using these formative data, we developed an intervention that is survivor-based and includes an in-person session which incorporates sharing personal stories, communication skills training and decision support. Intervention materials were reviewed by community members, researchers/clinicians and patients newly diagnosed with breast cancer. CONCLUSION: Patients reported satisfaction with the intervention and felt better prepared to talk with providers. The intervention will be tested in a randomized trial to enhance decision support and increase use of indicated adjuvant treatment.

Stress management intervention reduces serum cortisol and increases relaxation during treatment for nonmetastatic breast cancer.

OBJECTIVE: To examine the effects of a cognitive-behavioral stress management (CBSM) intervention, which was composed of relaxation, cognitive restructuring, and coping skills training on late afternoon serum cortisol and relaxation indicators in women who were undergoing treatment for nonmetastatic breast cancer. METHODS: Participants (N = 128) were randomly assigned to receive a 10-week CBSM group intervention or a 1-day psychoeducation seminar. Serum cortisol was collected and ability to relax was assessed at study entry and again at 6- and 12-month follow-up visits. Data were analyzed using latent growth curve modeling. RESULTS: There was a significant effect of study condition on change across time for both cortisol and perceived ability to relax. Women receiving CBSM had significantly greater reductions in cortisol levels across the 12 months compared with those in the control group, who had no appreciable decline. Women receiving CBSM reported greater increases in ability to relax than controls across time. Perceived ability to relax did not mediate CBSM-related reductions in cortisol. CONCLUSIONS: Women who participate in a 10-week CBSM intervention during treatment for breast cancer show decreases in physiological stress in parallel with increases in perceived relaxation skills. This is the first study demonstrating well-maintained reductions in cortisol after a CBSM intervention in cancer patients during and just after treatment.

Chemotherapy-induced nausea, vomiting, and fatigue--the role of individual differences related to sensory perception and autonomic reactivity.

BACKGROUND: In spite of antiemetics, postchemotherapy side effects continue to be common and may affect compliance to cancer treatment. Among the known factors associated with increased symptom severity are: younger age, treatment toxicity, expected severity, and distress, but little is still known about the role of other factors. The aim of our study was to investigate the role of individual differences related to sensory perception for posttreatment side effects. METHODS: Hundred and twenty-five women receiving adjuvant chemotherapy for breast cancer completed measures of absorption, autonomic perception, somatosensory amplification, trait anxiety, and expected severity at baseline. Pretreatment distress and posttreatment nausea, vomiting, and fatigue were assessed at the 1st, 4th, 6th and last cycles of chemotherapy. RESULTS: While univariate analyses showed several factors to be associated with side effects, only absorption and pretreatment distress remained independent predictors of nausea and fatigue when controlling for the remaining factors. Posttreatment vomiting was only predicted by expected severity of vomiting. CONCLUSION: Chemotherapy-induced side effects are related to increased autonomic nervous system activity, and absorption has been associated with increased autonomic nervous system reactivity to stress. The results suggest that individuals with high absorption may be at greater risk for developing side effects. Improved precision in identifying patients at risk of experiencing more severe side effects after cancer treatment will increase the ability to target treatments aimed at reducing these side effects.

Anticipatory nausea: the role of individual differences related to sensory perception and autonomic reactivity.

BACKGROUND: Anticipatory nausea (AN) during chemotherapy has been difficult to control with conventional antiemetics. AN can lead cancer patients to delay or discontinue chemotherapy, possibly compromising the treatment. PURPOSE: The aim is to investigate the possible influence on the development of AN of individual differences in absorption, somato-sensory amplification, and autonomic perception-measures theorized to be related to sensory perception and autonomic reactivity. METHODS: Prior to treatment, 125 women (M age = 48.5 years) undergoing adjuvant chemotherapy for breast cancer rated their expected severity of side effects and completed the Tellegen Absorption Scale, the Somato-Sensory Amplification Scale, and the Autonomic Perception Questionnaire. AN, as well as anticipatory vomiting (AV), distress, and worry/anxiety, were measured prior to the fourth, sixth, and last cycle of chemotherapy. Posttreatment nausea (PN), vomiting, and fatigue were measured after the first, fourth, sixth, and last cycle. RESULTS: 34% of the women reported AN before 1 or more cycles. When controlling for treatment characteristics and other known predictors, AN was significantly associated with high absorption in addition to severity of PN, pretreatment worry/anxiety, and not receiving radiotherapy between chemotherapy sessions. AV was not associated with any of the variables investigated. Our data suggest that the association is strongest in the early phases of treatment. CONCLUSIONS: Our results partly confirm the results of a previous study showing absorption and autonomic perception as predictors of anticipatory side effects in cancer patients receiving chemotherapy. Individuals high in absorption may be more autonomically reactive to aversive stimuli and, subsequently, more conditionable. Additional radiotherapy could be a competing stimulus, reducing the conditioning of chemotherapy-related nausea. Further studies investigating possible psycho-physiological mechanisms in the development of AN are needed.

Anxiety and quality of life of women who receive radiation or chemotherapy for breast cancer.

PURPOSE/OBJECTIVES: To examine quality of life (QOL) and anxiety in a sample of women receiving radiation or chemotherapy for breast cancer. DESIGN: Longitudinal, descriptive. SETTING: A cancer center in the southeastern United States. SAMPLE: 48 women participated; 17 received radiation and 31 received chemotherapy. METHODS: The Ferrans and Powers Quality of Life Index (QLI) and Speilberger's State-Trait Anxiety Inventory (STAI) were administered. The QLI was administered at the start of treatment and one year later. The STAI was administered at the start of treatment. The state portion of the STAI also was administered 4 weeks and 12 weeks after the start of treatment. MAIN RESEARCH VARIABLES: QOL and anxiety. FINDINGS: Total QOL improved significantly over time for the entire sample, as did scores on the health/functioning, psychological/spiritual, and family subscales of the QLI. No significant differences existed for total QOL or any subscales by treatment. Trait anxiety was significantly higher for women receiving chemotherapy, and state anxiety was significantly higher at all three measurement times for the women. State anxiety did not decrease significantly over the course of the treatment for either group. Trait anxiety and state anxiety at the start of treatment were significantly negatively correlated with total QLI score and the psychological/spiritual subscale. State anxiety at the start of treatment also was significantly negatively correlated with total QOL and the health/functioning and psychological/spiritual QLI subscales both at the start of treatment and one year later. CONCLUSIONS: QOL improves over time for women who have received radiation or chemotherapy. Women receiving chemotherapy have higher anxiety scores, and higher anxiety at the start of treatment is associated with decreased QOL at the start of treatment and postdiagnosis. IMPLICATIONS FOR NURSING: Nursing interventions to reduce anxiety at the start of treatment, especially for chemotherapy recipients, are indicated. Research also should target methods to reduce anxiety at the start of treatment.

How women receiving adjuvant chemotherapy for breast cancer cope with their treatment: a risk management perspective.

Retrospective interviews were undertaken with 12 women who had received an 18-week course of adjuvant chemotherapy for positive node breast cancer 1 year previously, and who had not experienced cancer recurrence. The nonstandardized interviews covered women's preconceptions about adjuvant chemotherapy, their information needs, and the impact of treatment. The qualitative data analysis drew upon the theoretical ideas of patient career, trajectory projection and qualitative risk analysis. Some women regarded adjuvant chemotherapy as no more than an 'insurance policy'. This perception may have arisen because doctors, attempting to minimize patient anxiety, did not discuss the high risk of disease recurrence which they faced. Other women equated adjuvant with curative chemotherapy, and anticipated hair loss or almost certain death. The women tried to cope with the physical and mental suffering associated with adjuvant chemotherapy through normalizing strategies, such as keeping a brave face, maintaining previous patterns of life, looking for humour and restructuring time. However, the rapid alterations in physical and mental state resulting from cycles of adjuvant chemotherapy resulted in a 'rollercoaster' experience for women which made normalization more difficult. Health professionals caring for women who must cope with uncertain future trajectories need to manage a risk communication dilemma. A strategy of fully informing women about the risks they face may cause anxiety or depression, and even impede recovery, given the evidence for psychological influences on health outcomes. But, if women do not understand the medical thinking on which their treatment is based, their misconceptions may be equally damaging.

Preparing patients for cancer chemotherapy: effect of coping preparation and relaxation interventions.

Sixty cancer chemotherapy patients were randomly assigned to one of four treatments: (a) relaxation training with guided relaxation imagery (RT), (b) general coping preparation package (PREP), (c) both RT and PREP, or (d) routine clinic treatment only. All patients were assessed on self-report, nurse observation, family observation, and physiological measures and were followed for five sequential chemotherapy treatments. Results indicate that the PREP intervention increased patients' knowledge of the disease and its treatment, reduced anticipatory side effects, reduced negative affect, and improved general coping. RT patients showed some decrease in negative affect and vomiting, but not as great as in past studies. The data suggest that a relatively simple, one-session coping preparation intervention can reduce many different types of distress associated with cancer chemotherapy and may be more effective than often-used behavioral relaxation procedures.