Family caregivers of those with cancer: quality of life outcomes from a sequential multiple assignment randomized trial.

PURPOSE: To conduct a secondary analysis focused on health-related quality of life (HRQOL) among caregivers engaged in a 12-week complementary therapy sequential multiple assignment randomized trial (SMART) of reflexology and/or meditative practices (MP), to manage cancer patients' symptoms. METHODS: In this SMART, patient-caregiver dyads were initially randomized to 4 weeks of caregiver-delivered reflexology for the patient (N = 150), MP with the patient (N = 150), or control (N = 47). After 4 weeks, dyads with patients not improving on fatigue (non-responders, n = 69 to reflexology and n = 57 to MP) were re-randomized to continue the same therapy or add the other therapy for an additional 4 weeks. Week-12 caregiver HRQOL was measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 and the Caregiver Reaction Assessment Tool (CRAT) for caregiver burden; scores were analyzed using general linear models. RESULTS: In the comparison of 4 adaptive intervention sequences: reflexology for 8 weeks, reflexology for 4 weeks followed by MP for 4 weeks if no response to reflexology, MP for 8 weeks, and MP for 4 weeks followed by reflexology for 4 weeks if no response to MP, there were no differences in PROMIS-29 scores. However, CRAT domains of impact on schedule, family support, and finances worsened when adding reflexology after the first 4 weeks of MP. The CRAT domain of health worsened by adding either intervention compared to continuing the same one. CONCLUSIONS: Clinicians should be aware that caregiver engagement in more than one complementary therapy may increase caregiver burden in some domains but not affect other HRQOL domains. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02759146.

Engaging Patients in Research That Involves Meditation: Religious Concerns and Nursing Implications.

BACKGROUND: Studies evaluating the use of meditative practices for supporting symptom management among patients undergoing cancer treatment have increased substantially in recent years. Although meditative practices as adjuncts to promoting health have become mainstream, concerns that such strategies conflict with traditional religious tenets have co-occurred. In the context of a 12-week sequential multiple assignment randomized trial of home-based meditative practices and reflexology delivered to patients with cancer by or with family caregivers to manage symptoms, early attrition was identified in the meditative practices arm. OBJECTIVE: Finding religious concerns were factors contributing to attrition; the purpose is to describe adjustments to the training protocol for study recruiters and interveners when enrolling participants and teaching patient-caregiver dyads meditative practices. METHODS: The training protocol for recruiters and interveners was adapted to address religious concerns related to meditative practices. RESULTS: Since initiation, recruiters and interveners have appreciated the adapted protocol, which has improved their capacity to respond to religious concerns. Participants have responded well to consideration of the practices as mindful movements coordinated with breath. CONCLUSIONS: Given broader application of meditation in symptom management studies, researchers will need to be ready to address religious concerns. It is essential that protocols for introducing meditation are broadly presented to respond to concerns of patients and cancer caregivers regarding perceived conflicts with their specific religious beliefs. IMPLICATIONS FOR PRACTICE: As the provision of integrative care options that include meditation training for patients grows, nurses require awareness of potential barriers and strategies to ameliorate religious concerns.

An Evaluation of Natural Environment Interventions for Informal Cancer Caregivers in the Community.

Home-based informal caregiving by friends and family members of patients with cancer is be-coming increasingly common globally with rates continuing to rise. Such caregiving is often emo-tionally and cognitively demanding, resulting in mental exhaustion and high perceived burden. Support for caregivers may be fostered by engagement with the natural environment. Interaction with nature is associated with mental health benefits such as stress reduction and improved well-being. The purpose of this paper was to evaluate the state of the science regarding the use of nat-ural environment interventions to support caregivers of cancer patients in the community. A comprehensive scoping review using the Arksey and O'Malley framework and the Preferred Re-porting Items for Systematic Reviews and Meta-analyses assessed natural environment therapies and mental health outcomes among cancer caregivers. Databases searched included CINAHL, PubMed, Scopus, Cochrane, and Alt HealthWatch. Findings recovered a total of five studies over a 10-year period that met criteria, demonstrating a lack of empirical evidence addressing this po-tential resource to support caregivers. Often, study appraisal was not on nature exposure, but ra-ther other aspects of the projects such as program evaluation, exercise, or complementary thera-pies. Both qualitative and quantitative designs were used but sample sizes were small. Caregivers experienced beneficial results across the various studies and future work could enhance these findings.

Reflexology and meditative practices for symptom management among people with cancer: Results from a sequential multiple assignment randomized trial.

Optimal sequencing of complementary therapies can help improve symptom management through nonpharmacological approaches. A 12-week sequential multiple assignment randomized trial comparing home-based reflexology and meditative practices on severity of fatigue and other symptoms was conducted among patients with cancer and their informal caregivers. Dyads were initially randomized to reflexology (N = 150), meditative practices (N = 150), or control (N = 47). If patient's fatigue did not improve (nonresponse) after 4 weeks of reflexology or meditative practices, the dyad was rerandomized to either add the other therapy or continue with the original therapy for weeks 5-8. Four decision rules (DRs) were compared: (1) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, continue with reflexology for another 4 weeks, thus providing a higher dose; (2) Initiating reflexology, and if nonresponse on fatigue after 4 weeks, add meditative practices for the next 4 weeks; (3) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, continue meditative practices for another 4 weeks, thus providing a higher dose; and (4) Initiating meditative practices, and if nonresponse on fatigue after 4 weeks, add reflexology for the next 4 weeks. Symptoms were evaluated weekly using the M.D. Anderson Symptom Inventory (MDASI). Clinically, nurses can recommend either therapy since no differences were found among the 4 DRs, with the exception of lower severity for summed MDASI symptoms at week 8 for the use of reflexology only (DR-1) versus DR-2 (sequencing reflexology to meditative practices). Adding the other therapy for nonresponders after 4 weeks may not be warranted.

Spirituality, Quality of Life, and End of Life Among Indigenous Peoples: A Scoping Review.

INTRODUCTION: While spirituality and quality of life (QOL) are essential components of end-of-life (EOL) care, limited studies have examined these constructs for indigenous peoples. Therefore, the purpose of this article was to examine the state of the science regarding spirituality and QOL at EOL for indigenous people, particularly Native Americans. METHOD: The Arksey and O'Malley (2005) framework guided this scoping review, which examined 30 articles that included qualitative and quantitative studies, commentary papers, and reviews. RESULTS: The findings identified five spiritual dimensions: the life and death journey, a belief in spirits, tribally grounded traditions, dominant cultural religion influences, and a family focus. QOL indicators included survivorship, optimization of holistic health, communication, and access to appropriate resources. Death rituals were important EOL elements. DISCUSSION: Given the importance of spirituality to QOL for indigenous people, clinicians must be knowledgeable and responsive to indigenous spiritual needs to promote QOL at EOL.

Pain and Spirituality Outcomes Among Women With Advanced Breast Cancer Participating in a Foot Reflexology Trial.

OBJECTIVES: To examine pain and spirituality, demographic and clinical factors associated with pain and spirituality, the contribution of spirituality to experiences of pain over time, and how pain and spirituality relate to engagement with a caregiver-delivered intervention. SAMPLE & SETTING: Women with advanced breast cancer (N = 256) enrolled in a home-based randomized controlled trial of foot reflexology. METHODS & VARIABLES: Secondary analyses were conducted with baseline and postintervention data. Stepwise model building, linear mixed-effects modeling, and negative binomial regression were used. RESULTS: Participants who were younger, not married or partnered, not employed, or receiving hormonal therapy had increased odds of higher pain levels. Those who were older, non-White, or Christian had increased odds of higher spirituality. Spirituality's contribution to pain was not significant over time. IMPLICATIONS FOR NURSING: Women in this sample experienced moderate pain, on average, at baseline. Women with specific demographic and clinical characteristics may require additional support with pain management and spiritual care.

Expectancy and Utilisation of Reflexology among Women with Advanced Breast Cancer.

OBJECTIVE: Little is understood about patient expectations and use of complementary therapies (CT) during cancer treatment. A secondary analysis of an 11-week reflexology trial among women with breast cancer was conducted. We examined factors that predicted women's expectations about reflexology for symptom relief, factors that predicted utilisation of reflexology, and whether by the end of the trial they believed that reflexology had helped with symptom management. METHODS: Women (N = 256) were interviewed at baseline and week 11. Friend or family caregivers in the reflexology group were trained to deliver standardised sessions to patients at least once a week for 4 weeks. Baseline and week-11 reflexology expectations were analysed using general linear models. Reflexology utilisation was analysed with generalised linear mixed effects models. RESULTS: Patients who expected benefits from reflexology ("higher expectancy") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use. Worsening symptoms over time were associated with greater utilisation of reflexology, but only when baseline expectancy was low. At week 11, expectancy was higher for those with greater symptom improvement. CONCLUSIONS: Assessing patterns of patient factors, expectancy, and change in symptoms can help determine who is likely to use reflexology, and when.

Symptom response analysis of a randomized controlled trial of reflexology for symptom management among women with advanced breast cancer.

PURPOSE: To examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregivers to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy. METHODS: Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analyzed using generalized estimating equations technique. RESULTS: Reflexology was more successful than attention control in producing responses for pain (OR = 1.84, 95% CI (1.05, 3.23), p = 0.03), with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants. CONCLUSIONS: Home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01582971.

The Prevalence and Types of Complementary and Integrative Health Therapies Used by Caregivers of Patients with Cancer.

OBJECTIVE: To assess rationale for usage and types of complementary and integrative health therapies used as self-care by unpaid cancer caregivers. DATA SOURCES: CINAHL, PubMed, PsycINFO, Embase, and Alt HealthWatch. CONCLUSION: Six articles provide updated information on caregiver preferences and desires relative to use of complementary and integrative health therapies. Findings largely focused on patients; whereas perceptions of caregivers were secondary. IMPLICATIONS FOR NURSING PRACTICE: Given shifts in cancer care from clinics to home, clinicians can increase their effectiveness through a better understanding of the caregiving experience, allowing for delivery of supportive, personalized interventions. Such support may include evidence-based complementary and integrative health therapies for caregivers.

Spiritual Perspectives on Pain in Advanced Breast Cancer: A Scoping Review.

OBJECTIVES: The aim of the present review was to characterize how pain and spirituality have been conceptualized, assessed, and addressed and how these concepts may be related among women with advanced breast cancer. DESIGN: A scoping review was conducted including publications of various methodologies. DATA SOURCES: Searches were conducted in PubMed, CINAHL, PsycINFO, Cochrane Library, OpenGrey, OAIster, and a large university library database (published 2006-2018). REVIEW/ANALYSIS METHODS: Research questions and criteria were formulated at the outset, followed by identification of publications, charting data, and collating results. RESULTS: Forty-two publications met the inclusion criteria. Most (n = 33) focused exclusively on pain, five pain and spirituality, and four exclusively spirituality. Conceptual definitions were not explicitly provided but were implied. Most assessments used the 0-10 Numeric Rating Scale (pain) and qualitative methods (spirituality). Pain management primarily focused on radiotherapy and pharmaceuticals, and two publications identified spiritual interventions. No publications directly examined the impact of spirituality on pain. Findings of qualitative studies including both concepts suggest the potential value of spirituality as a mechanism to cope with pain. CONCLUSIONS: This review identified significant unmanaged pain in women with advanced breast cancer. Women identified dimensions of spirituality as important for coping with their disease. A gap in understanding spirituality and its potential influence on pain in this population was identified.

Healthcare service utilization and work-related productivity in reflexology intervention for advanced breast cancer women.

PURPOSE: This project's purpose was to determine the effects of a home-based reflexology intervention on symptom-related use of health services and work-related productivity during the 11-week study. METHODS: A total of 256 patients were randomized to four weekly reflexology sessions (each lasting 30 min, delivered by lay caregivers who received two training sessions by a professional reflexologist) or attention control. The Conventional Health Service and Productivity Costs Form was used to collect information on health service utilization and out-of-pocket expenditure of symptom management. The Health and Work Performance Questionnaire was used to measure workplace performance for patients during the study period. We used weighted and unweighted logistic and linear regression analyses. RESULTS: Patients in the reflexology group were less likely to have hospital visits compared to the control group in the weighted unadjusted (odds ratio [OR] = 0.49; 95% confidence interval [CI] = [0.25, 0.97]), unweighted adjusted (OR = 0.35; 95% CI = [0.16, 0.75]), and weighted adjusted (OR = 0.30, 95% CI = [0.13, 0.66]) logistic regressions. Compared to attention control, patients in the reflexology group had lower relative absenteeism in the unweighted adjusted (- 0.32; 95% CI = [- 0.60, - 0.03]) linear regressions and less absolute presenteeism (15.42, 95% CI = [0.87, 29.98]) in the weighted unadjusted analysis. CONCLUSION: The reflexology intervention delivered by lay caregivers reduced hospital visits and increased workplace productivity in a short-term period, which has potential for cost saving for health care systems and employers. TRIAL REGISTRATION: NCT01582971.

PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial.

OBJECTIVE: Accurate and efficient measurement of patient-reported outcomes is key in cancer symptom management trials. The newer Patient Reported Outcomes Measurement Information System (PROMIS) and previously developed measures of similar conceptual content (legacy) are available to measure symptoms and functioning. This report compares the performance of two sets of measures, PROMIS and legacy, in a recently completed trial of a supportive care intervention that enrolled breast cancer patients and their friend or family caregivers. METHODS: Patient-caregiver dyads (N = 256) were randomized to either reflexology delivered by caregivers or usual care control. Post-intervention, PROMIS and legacy measures of symptoms and functioning were analyzed in relation to trial arm, while adjusting for baseline values. Responsiveness of the two sets of measures was assessed using effect sizes and P-values for the effect of trial arm on patients' and caregivers' symptom and functioning outcomes. RESULTS: Similar conclusions about intervention effects were found using PROMIS and legacy measures for pain, fatigue, sleep, anxiety, physical, and social functioning. Different conclusions were obtained for patient and caregiver depression: legacy measures indicated the efficacy of reflexology, while PROMIS depression measure did not. CONCLUSION: Evidence of similar responsiveness supports the use of either set of measures for symptoms and functioning in clinical and general populations. Differences between PROMIS and legacy measures of depression need to be considered when choosing instruments for use in trials of supportive care interventions and in clinical practice.

Impact of Self-Acupressure on Co-Occurring Symptoms in Cancer Survivors.

BACKGROUND: Cancer survivors with fatigue often experience depressive symptoms, anxiety, and pain. Previously, we reported that self-acupressure improved fatigue; however, its impact on other co-occurring symptoms and their involvement in treatment action has not been explored. METHODS: Changes in depressive symptoms, anxiety, and pain were examined prior to and following two formulas of self-acupressure and usual care using linear mixed models in 288 women from a previously reported clinical trial. Participants were categorized by random assignment into one of three groups: 1) relaxing acupressure, 2) stimulating acupressure, or 3) usual care. Moderators investigated were body mass index, age, depressive symptoms, anxiety, sleep and pain, and mediators were change in these symptoms. RESULTS: Following treatment, depressive symptoms improved statistically significantly for the relaxing acupressure group (41.5%) compared with stimulating acupressure (25%) and usual care (7.7%). Both acupressure groups were associated with greater improvements in anxiety than usual care, but only relaxing acupressure was associated with greater reductions in pain severity, and only stimulating acupressure was associated with greater reductions in pain interference. There were no statistically significant moderators of sleep quality, anxiety, or depressive symptoms. Fatigue statistically significantly moderated pain, and age statistically significantly modified fatigue. Changes in depressive symptoms and sleep quality statistically significantly mediated the relationship between relaxing acupressure and usual care on fatigue; however, the effect was small. CONCLUSIONS: Acupressure was associated with greater improvements than usual care in anxiety, pain, and symptoms of depression in breast cancer survivors with troublesome fatigue. These findings warrant further evaluation in suitably controlled randomized trials.

Using SMART design to improve symptom management among cancer patients: A study protocol.

In this in-progress sequential multiple assignment randomized trial (SMART), dyads of solid tumor cancer patients and their caregivers are initially randomized to 4 weeks of reflexology or meditative (mindfulness) practices provided by/with their caregiver in the patient's home or to a control group. After 4 weeks, intervention group dyads in which patients do not show improvement in fatigue (non-responders) are re-randomized to either receive additional time with the same therapy during weeks 5-8 or to add the other therapy. The aims are (1) to compare reflexology and meditative practices groups during weeks 1-4 on patients' fatigue severity, summed symptom inventory score, depressive symptoms, and anxiety, so as to determine the relative effectiveness of these therapies and the characteristics of responders and non-responders to each therapy. (2) Among reflexology non-responders based on fatigue score at week 4, to determine patient symptom outcomes when meditative practices are added during weeks 5-8, versus continuing with reflexology alone. (3) Among meditative practices non-responders based on fatigue score at week 4, to determine patient symptom outcomes when reflexology is added during weeks 5-8, versus continuing with meditative practices alone. (4) To compare improvements in patient symptom outcomes among the three groups created by the first randomization. (5) To explore which dyadic characteristics are associated with optimal patient symptom outcomes, to determine tailoring variables for decision rules of future interventions. The trial has a target of 331 dyads post-attrition and has 150 dyads enrolled. We are overcoming challenges with dyadic recruitment and retention while maintaining fidelity.

Caregiver-Reported Health Outcomes: Effects of Providing Reflexology for Symptom Management to Women With Advanced Breast Cancer.

PURPOSE/OBJECTIVES: To determine the effects of delivering a reflexology intervention on health outcomes of informal caregivers, and to explore whether intervention effects are moderated by caregiver characteristics. 
. DESIGN: Two-group, randomized clinical trial.
. SETTING: Eight oncology clinics in urban and rural regions of Michigan and Illinois.
. SAMPLE: 180 informal caregivers of patients with advanced breast cancer.
. METHODS: Caregivers were randomized to provide reflexology to individuals with cancer during a four-week period or to attention control. Data collection occurred at baseline and at weeks 5 and 11. Linear mixed-effects modeling was used to test intervention effects among all participants and the effects of the number of sessions delivered in the reflexology group.
. MAIN RESEARCH VARIABLES: Caregiver characteristics; psychological, physical, and social outcomes.
. FINDINGS: Caregiver fatigue in the reflexology group was reduced compared to controls at weeks 5 (p = 0.02) and 11 (p = 0.05). No differences were found for anxiety, depression, pain, physical function, sleep disturbance, satisfaction with participation in social roles, and pain interference between caregivers who delivered reflexology and those who did not.
. CONCLUSIONS: Informal caregivers who provided reflexology to individuals with cancer did not have negative psychological, physical, or social outcomes. Fatigue levels were lower among caregivers who provided reflexology. 
. IMPLICATIONS FOR NURSING: Clinicians need to be aware that providing supportive care interventions, such as reflexology, to reduce symptom burden does not increase negative outcomes on informal caregivers who provide this care, and it may even lead to reduced fatigue.

A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment.

PURPOSE: The objective of this study was to determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared with attention control on health-related quality of life of women with advanced breast cancer undergoing chemotherapy, targeted and/or hormonal therapy. METHODS: Patient-caregiver dyads (N = 256) were randomized to four weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the four weeks, both groups had telephone symptom assessments, and intervention group had fidelity assessments. The intervention effects were assessed using linear mixed-effects models at weeks 5 and 11 for symptom severity and interference with daily activities, functioning, social support, quality of patient-caregiver relationship, and satisfaction with life. RESULTS: Significant reductions in average symptom severity (P = 0.02) and interference (P < 0.01) over 11 weeks were found in the reflexology group compared with control, with no group differences in functioning, social support, quality of relationship, or satisfaction with life at weeks 5 and 11. Stronger quality of relationship was associated with lower symptom interference in the entire sample (P = 0.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared with attention control were seen during weeks 2-5 but were reduced at Week 11. DISCUSSION: Efficacy findings of caregiver-delivered reflexology with respect to symptom reduction open a new evidence-based avenue for home-based symptom management.

Fidelity scorecard: evaluation of a caregiver-delivered symptom management intervention.

AIM: To evaluate and quantify the intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for people with breast cancer. BACKGROUND: Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results. DESIGN: Fidelity assessment of a 4-week intervention protocol in a randomized controlled trial (RCT) with data collection between 2012 - 2016. METHODS: The National Institutes of Health Behaviour Change Consortium (NIH-BCC) conceptual model for intervention fidelity guided the study. The five NIH-BCC fidelity elements are: (1) dose; (2) provider training; (3) intervention delivery; (4) intervention receipt; and (5) enactment. To illustrate the elements, an intervention protocol was deconstructed and each element quantified using a newly developed fidelity scorecard. RESULTS: Mean scores and frequency distributions were derived for the scorecard elements. For dose, the mean number of sessions was 4·4, 96% used the correct intervention duration and 29% had 4 weeks with at least one session. Provider training was achieved at 80% of the maximum score, intervention delivery was 96%, intervention receipt was 99% and enactment indicated moderate adoption at 3·8 sessions per patient. The sample mean score was 15·4 out of 16, indicating the high overall fidelity. CONCLUSION: Research findings that include description of how fidelity is both addressed and evaluated are necessary for clinical translation. Clinicians can confidently recommend symptom management strategies to patients and caregivers when fidelity standards are explicitly reported and measured.

Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.

IMPORTANCE: Fatigue is a common and debilitating late-term effect of breast cancer that is associated with poor sleep and decreased quality of life, yet therapies remain limited. Acupressure has reduced fatigue in previous small studies, but rigorous clinical trials are needed. OBJECTIVES: To investigate if 6 weeks of 2 types of self-administered acupressure improved fatigue, sleep, and quality of life vs usual care in breast cancer survivors and to determine if changes were sustained during a 4-week washout period. DESIGN, SETTING, AND PARTICIPANTS: Phase 3 randomized, single-blind, clinical trial conducted from March 1, 2011, through October 31, 2014. Women were recruited from the Michigan Tumor Registry. INTERVENTIONS: Randomization (1:1:1) to 6 weeks of daily self-administered relaxing acupressure, stimulating acupressure, or usual care. MAIN OUTCOMES AND MEASURES: The primary outcome was change in the Brief Fatigue Inventory score from baseline to weeks 6 and 10. Secondary analyses were sleep (Pittsburgh Sleep Quality Index) and quality of life (Long-Term Quality of Life Instrument). RESULTS: A total of 424 survivors of stages 0 to III breast cancer who had completed cancer treatments at least 12 months previously were screened, and 288 were randomized, with 270 receiving relaxing acupressure (n = 94), stimulating acupressure (n = 90), or usual care (n = 86). One woman withdrew owing to bruising at the acupoints. At week 6, the percentages of participants who achieved normal fatigue levels (Brief Fatigue Inventory score <4) were 66.2% (49 of 74) in relaxing acupressure, 60.9% (42 of 70) in stimulating acupressure, and 31.3% (26 of 84) in usual care. At week 10, a total of 56.3% (40 of 71) in relaxing acupressure, 60.9% (42 of 69) in stimulating acupressure, and 30.1% (25 of 83) in usual care continued to have normal fatigue. At neither time point were the 2 acupressure groups significantly different. Relaxing acupressure, but not stimulating acupressure, showed significant improvements in sleep quality compared with usual care at week 6, but not at week 10. Only relaxing acupressure significantly improved quality of life vs usual care at weeks 6 and 10. CONCLUSIONS AND RELEVANCE: Both acupressure arms significantly reduced persistent fatigue compared with usual care, but only relaxing acupressure had significant effects on sleep quality and quality of life. Relaxing acupressure offers a possible low-cost option for managing symptoms. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01281904.

Xerostomia health-related quality of life: NRG oncology RTOG 0537.

PURPOSE: The purpose of this secondary analysis was to determine change in overall health-related quality of life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS). METHODS: A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9, and 15 months after the date of randomization. RESULTS: There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet nonsignificant improvement in outcomes compared to the PC arm. CONCLUSION: Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

CONTEXT: Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. OBJECTIVES: To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. METHODS: The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. RESULTS: The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. CONCLUSION: SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation.