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OBJECTIVES: Concurrent chemoradiation to treat head and neck cancer (HNC) may result in debilitating toxicities. Targeted exercise such as yoga therapy may buffer against treatment-related sequelae; thus, this pilot RCT examined the feasibility and preliminary efficacy of a yoga intervention. Because family caregivers report low caregiving efficacy and elevated levels of distress, we included them in this trial as active study participants. METHODS: HNC patients and their caregivers were randomized to a 15-session dyadic yoga program or a waitlist control (WLC) group. Prior to randomization, patients completed standard symptom (MDASI-HN) and patients and caregivers completed quality of life (SF-36) assessments. The 15-session program was delivered parallel to patients' treatment schedules. Participants were re-assessed at patients' last day of chemoradiation and again 30 days later. Patients' emergency department visits, unplanned hospital admissions and gastric feeding tube placements were recorded over the treatment course and up to 30 days later. RESULTS: With a consent rate of 76%, 37 dyads were randomized. Participants in the yoga group completed a mean of 12.5 sessions and rated the program as "beneficial." Patients in the yoga group had clinically significantly less symptom interference and HNC symptom severity and better QOL than those in the WLC group. They were also less likely to have a hospital admission (OR = 3.00), emergency department visit (OR = 2.14), and/or a feeding tube placement (OR = 1.78). CONCLUSION: Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation. A larger efficacy trial is warranted.
Subject(s)
Caregivers , Chemoradiotherapy , Head and Neck Neoplasms , Quality of Life , Yoga , Humans , Male , Female , Caregivers/psychology , Middle Aged , Head and Neck Neoplasms/therapy , Aged , Treatment Outcome , Pilot Projects , Feasibility Studies , AdultABSTRACT
Introduction: During the COVID-19 pandemic, health care workers (HCWs) experienced increased anxiety, depression, loneliness, and other mental health issues. HCWs need additional resources to cope with the mental health impact of their work. Yoga techniques could be helpful strategies to manage different stressors during times of uncertainty. Methods: This prospective, single-arm, trial examined the effects of a brief pranayama yoga practice on the wellbeing of HCWs during the height of COVID-19. HCWs were recruited through announcements and institutional websites at a large major cancer center in the southern United States. A short, prerecorded, 5-min breathwork video intervention called "Simha Kriya" was provided to participants, and they were encouraged to practice one to two times daily for 4 weeks. Participants completed self-report instruments at baseline and weeks 1 and 4, including: (1) Perceived Stress Scale (PSS); (2) Brief Resilient Coping Scale (BRCS); and (3) a questionnaire assessing the experience of COVID-19 among HCWs that had five subscales. HCWs also conducted a measure of breath holding time. Paired sample t-tests and mixed-effects analysis of variance models examined changes over time. Results: One hundred participants consented to the study, with 88 female, 60 white, 39 worked remotely, and 27 were clinical staff. Sixty-nine participants provided data at week 1 and 56 at week 4. Participants' adherence to the breathing exercises between weeks 1 and 4 was similar, with a mean of six times per week. At week 4, there were significant decreases in the COVID-19 Distress score (p < 0.0001) and COVID-19 Disruption (p = 0.013), yet no changes in the PSS. There were also significant increases in COVID-19 Stress Management (p = 0.0001) and BRCS scores (p = 0.012), but no changes in Perceived Benefits of COVID-19 and no changes in breath holding time. Discussion: Brief yoga-based breathing practices helped reduce pandemic-specific stress, improved resilience, and stress management skills in HCWs. Trial Registration Number: NCT04482647.
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BACKGROUND: Yoga is an evidence-based mind-body practice known to improve physical and mental health in cancer patients. We report on the processes and patient-reported outcomes of one-on-one yoga therapy (YT) consultations delivered via telehealth. METHODS: For patients completing a YT consultation between March 2020 and October 2021, we examined demographics, reasons for referral, and self-reported symptom burden before and after one YT session using the Edmonton Symptom Assessment Scale (ESAS). Changes in ESAS symptom and subscale scores [physical distress (PHS), psychological distress (PSS), and global distress (GDS)] were evaluated by Wilcoxon signed-rank test. Descriptive statistics summarized the data. RESULTS: Ninety-seven initial YT consults were completed, with data evaluated for 95 patient encounters. The majority were women (83.2%) and white (75.8%), The mean age for females was 54.0 and for males was 53.4; the most common diagnosis was breast cancer (48%), 32.6% had metastatic disease, and nearly half (48.4%) were employed full-time. Mental health (43.0%) was the most common reason for referral, followed by fatigue (13.2%) and sleep disturbances (11.7%). The highest symptoms at baseline were sleep disturbance (4.3), followed by anxiety (3.7) and fatigue (3.5). YT lead to clinically and statistically significant reductions in PHS (mean change = -3.1, P < .001) and GDS (mean change = -5.1, P < .001) and significant reductions in PSS (mean change = -1.6, P < .001). Examination of specific symptom scores revealed clinically and statistically significant reductions in anxiety (mean change score -1.34, P < .001) and fatigue (mean change score -1.22, P < .001). Exploratory analyses of patients scoring ≥1 for specific symptoms pre-YT revealed clinically and statistically significant improvements in almost all symptoms and those scoring ≥4 pre-YT. CONCLUSIONS: As part of an integrative oncology outpatient consultation service, a single YT intervention delivered via telehealth contributed to a significant improvement in global, physical, and psychosocial distress. Additional research is warranted to explore the long-term sustainability of the improvement in symptoms.
Subject(s)
Breast Neoplasms , COVID-19 , Yoga , Humans , Female , Male , Pandemics , Quality of Life/psychology , COVID-19/epidemiology , Yoga/psychology , Fatigue/therapyABSTRACT
Introduction: There is limited research regarding the benefits of mind-body practices such as meditation in hospitalized patients with an active diagnosis of any cancer type. Methods: We conducted a prospective, randomized, clinical trial (NCT03445572) comparing 2 meditative practices-Isha Kriya (IK) and meditative slow breathing (MSB)-versus wait-list controls in hospitalized cancer patients. Our aim was to determine the feasibility of meditation practice in cancer inpatients. Feasibility was defined as recruitment of more than 50% of the eligible patients approached and at least 60% of the patients having meditated at least 4 days by day 7. Acceptability was assessed on day 7 as a positive response on at least 2 questions on the modified Global Symptom Evaluation (GSE) scale. Results: Forty patients (39% of the eligible patients approached) consented to participate in the study and were randomly assigned to the MSB (n = 13), IK (n = 14), or wait-list (n = 13) groups. Of the 27 patients assigned to receive MSB and IK meditations, day 7 data were available for 18 patients. Fifteen of the 18 patients meditated at least once in the first 7 days, and most (12/15) responded positively on the GSE. Conclusion: Both IK and MSB meditations were acceptable among the hospitalized cancer patients. Feasibility for enrollment and practice was likely not achieved due to limited uninterrupted time for daily meditation, high levels of morbidity in some participants, and limited research staff support. Shorter term outcomes should be explored in future meditation studies involving hospitalized cancer patients.
Subject(s)
Inpatients , Meditation/methods , Mind-Body Therapies/methods , Neoplasms , Feasibility Studies , Female , Humans , Inpatients/psychology , Inpatients/statistics & numerical data , Male , Middle Aged , Needs Assessment , Neoplasms/physiopathology , Neoplasms/psychology , Neoplasms/therapy , Outcome and Process Assessment, Health Care , Patient Acceptance of Health Care/psychology , Patient Acceptance of Health Care/statistics & numerical data , Psychosocial Support Systems , Severity of Illness Index , Time FactorsABSTRACT
BACKGROUND: While the use of behavioral medicine in managing glioma patients' symptoms is not well studied, the high symptom burden in patients and their family caregivers is well established. We conducted a pilot randomized, controlled trial to examine the feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy. METHODS: Glioma patients undergoing radiotherapy and their caregivers were randomized to a 12-session DY or waitlist control (WLC) group. Prior to radiotherapy and randomization, both groups completed measures of cancer-related symptoms (MD Anderson Symptom Inventory-Brain Tumor module), depressive symptoms (Center for Epidemiological Studies-Depression measure), fatigue (Brief Fatigue Inventory), and overall quality of life (QOL; Medical Outcomes Study 36-item short-form survey). Dyads were reassessed at the last day of radiotherapy. RESULTS: Twenty patients (mean age: 46 years, 50% female, 80% WHO grade IV and caregivers (mean age: 50 years, 70% female, 50% spouses) participated in the trial. A priori feasibility criteria were met regarding consent (70%), adherence (88%), and retention (95%) rates. Controlling for relevant covariates, change score analyses revealed clinically significant improvements for patients in the DY compared with the WLC group for overall cancer symptom severity (d = 0.96) and symptom interference (d = 0.74), depressive symptoms (d = 0.71), and mental QOL (d = 0.69). Caregivers in the DY group reported clinically significant improvements in depressive symptoms (d = 1.12), fatigue (d = 0.89), and mental QOL (d = 0.49) relative to those in the WLC group. CONCLUSION: A DY intervention appears to be a feasible and beneficial symptom and QOL management strategy for glioma patients undergoing radiotherapy and their caregivers. An efficacy trial with a more stringent control group is warranted. CLINICAL TRIAL NUMBER: NCT02481349.
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Background: This small qualitative study reports on the experiences of patients and family caregivers who participated in a dyadic yoga pilot trial while undergoing cancer treatment in the midst of Hurricane Harvey. Our primary purpose was to determine if participants implemented components of the program to cope with the stressors associated with Hurricane Harvey and if they perceived benefits from the yoga practices. Methods: We administered brief semistructured interviews to the dyads participating in a dyadic yoga pilot trial. Participants (n = 5 dyads) were asked to discuss their experience with Hurricane Harvey, including factors that helped them cope with the event while receiving treatment. Result: Patients had a mean age of 55.6 years, were mostly non-Hispanic White, male, and had advance stage head and neck cancer. Caregivers had a mean age of 58 years and were mainly non-Hispanic White and female. Analyses of the interviews revealed 2 overarching themes: (1) the storm's negative impact and (2) the use of yoga to cope with the hurricane-related stressors. Conclusions: Patient-caregiver dyads experienced psychological distress during the storm and/or its aftermath. Dyads used yoga techniques to cope with these psychological stressors. Yoga served as a means of social support as dyads either participated in these activities together or with other family members.
Subject(s)
Caregivers/psychology , Head and Neck Neoplasms/psychology , Stress, Psychological/psychology , Yoga/psychology , Adaptation, Psychological/physiology , Adult , Aged , Cyclonic Storms , Disease Management , Female , Humans , Male , Meditation/psychology , Middle Aged , Natural Disasters , Quality of Life/psychology , Social Support , Young AdultABSTRACT
OBJECTIVE: Thoracic radiotherapy (TRT) may result in toxicities that are associated with performance declines and poor quality of life (QOL) for patients and their family caregivers. The purpose of this randomized controlled trial was to establish feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy. METHODS: Patients with stage I to III non-small cell lung or esophageal cancer undergoing TRT and their caregivers (N = 26 dyads) were randomized to a 15-session DY or a waitlist control (WLC) group. Prior to TRT and randomization, both groups completed measures of QOL (SF-36) and depressive symptoms (CES-D). Patients also completed the 6-minute walk test (6MWT). Dyads were reassessed on the last day of TRT and 3 months later. RESULTS: A priori feasibility criteria were met regarding consent (68%), adherence (80%), and retention (81%) rates. Controlling for relevant covariates, multilevel modeling analyses revealed significant clinical improvements for patients in the DY group compared with the WLC group for the 6MWT (means: DY = 473 m vs WLC = 397 m, d = 1.19) and SF-36 physical function (means: DY = 38.77 vs WLC = 30.88; d = .66) and social function (means: DY = 45.24 vs WLC = 39.09; d = .44) across the follow-up period. Caregivers in the DY group reported marginally clinically significant improvements in SF-36 vitality (means: DY = 53.05 vs WLC = 48.84; d = .39) and role performance (means: DY = 52.78 vs WLC = 48.59; d = .51) relative to those in the WLC group. CONCLUSIONS: This novel supportive care program appears to be feasible and beneficial for patients undergoing TRT and their caregivers. A larger efficacy trial with a more stringent control group is warranted.
Subject(s)
Caregivers/psychology , Depression/psychology , Esophageal Neoplasms/psychology , Lung Neoplasms/psychology , Yoga/psychology , Adaptation, Psychological , Adult , Female , Humans , Male , Middle Aged , Pilot Projects , Quality of Life , Social AdjustmentABSTRACT
BACKGROUND: Complementary and integrative health approaches such as yoga provide support for psychosocial health. We explored the effects of group-based yoga classes offered through an integrative medicine center at a comprehensive cancer center. METHODS: Patients and caregivers had access to two yoga group classes: a lower intensity (YLow) or higher intensity (YHigh) class. Participants completed the Edmonton Symptom Assessment System (ESAS; scale 0-10, 10 most severe) immediately before and after the class. ESAS subscales analyzed included global (GDS; score 0-90), physical (PHS; 0-60), and psychological distress (PSS; 0-20). Data were analyzed examining pre-yoga and post-yoga symptom scores using paired t-tests and between types of classes using ANOVAs. RESULTS: From July 18, 2016, to August 8, 2017, 282 unique participants (205 patients, 77 caregivers; 85% female; ages 20-79 years) attended one or more yoga groups (mean 2.3). For all participants, we observed clinically significant reduction/improvement in GDS, PHS, and PSS scores and in symptoms (ESAS decrease ≥1; means) of anxiety, fatigue, well-being, depression, appetite, drowsiness, and sleep. Clinically significant improvement for both patients and caregivers was observed for anxiety, depression, fatigue, well-being, and all ESAS subscales. Comparing yoga groups, YLow contributed to greater improvement in sleep versus YHigh (-1.33 vs -0.50, P = .054). Improvement in fatigue for YLow was the greatest mean change (YLow -2.12). CONCLUSION: A single yoga group class resulted in clinically meaningful improvement of multiple self-reported symptoms. Further research is needed to better understand how yoga class content, intensity, and duration can affect outcomes.
Subject(s)
Caregivers/psychology , Neoplasms/psychology , Yoga/psychology , Adult , Aged , Anxiety/psychology , Anxiety/therapy , Depression/psychology , Depression/therapy , Fatigue/psychology , Fatigue/therapy , Female , Humans , Male , Meditation/psychology , Middle Aged , Quality of Life/psychology , Self Report , Sleep/physiology , Young AdultABSTRACT
BACKGROUND: Despite their high symptom burden and poor prognosis, evidence-based supportive care interventions for adults with high-grade glioma (HGG) and their caregivers are lacking. Thus, we aimed to establish feasibility of a patient-caregiver dyadic yoga program (DYP) for newly diagnosed HGG patients and their family caregivers targeting quality-of-life (QOL) outcomes. METHOD: In this single-arm pilot trial, dyads participated in a 12-session DYP program across the course of patients' radiotherapy. The intervention focused on breathing exercises, gentle movements, and guided meditations. We tracked feasibility data and assessed levels of cancer-related symptoms (MD Anderson Symptom Inventory [MDASI]), depressive symptoms (Centers for Epidemiological Studies-Depression scale), fatigue (Brief Fatigue Inventory), sleep disturbances (Pittsburgh Sleep Quality Index [PSQI]), and overall mental and physical QOL (36-item Short-Form Survey [SF-36]) at baseline and post-DYP, which was at the end of radiotherapy. RESULTS: We approached 6 dyads of which 5 dyads (86%) consented and completed all 12 sessions and pre/post assessments. All patients (mean age: 52 years, 80% female, 80% grade IV) and caregivers (mean age: 58 years, 80% female, 60% spouses) perceived benefit from the program. Paired t tests revealed a marginally significant, yet clinically meaningful, decrease in patient's cancer symptoms ( t = 2.32, P = .08; MDASI mean; pre = 1.75, post = 1.04). There were clinically significant reductions in patient sleep disturbances (PSQI mean: pre = 10.75, post = 8.00) and improvements in patient and caregiver mental QOL (MCS of SF-36 mean: pre = 42.35, post = 52.34, and pre = 45.14, post = 51.43, respectively). CONCLUSIONS: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for HGG patients and their caregivers. There was also preliminary evidence regarding QOL treatment gains for both patients and caregivers.
Subject(s)
Caregivers/psychology , Glioma/psychology , Glioma/radiotherapy , Yoga/psychology , Adaptation, Psychological/physiology , Adult , Aged , Depression/psychology , Fatigue/psychology , Female , Humans , Male , Meditation/psychology , Middle Aged , Quality of Life/psychology , Sleep Wake Disorders/psychology , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). METHODS: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. RESULTS: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations. CONCLUSION: Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.
Subject(s)
Breast Neoplasms/psychology , Counseling/methods , Diet/psychology , Disease-Free Survival , Exercise/psychology , Female , Humans , Life Style , Middle Aged , Neoplasm Recurrence, Local/psychology , Patient Compliance/psychologyABSTRACT
BACKGROUND: The primary purpose of this study was to establish the feasibility of a couple-based Vivekananda Yoga (VKC) intervention in lung cancer patients and caregivers. Secondly, we examined preliminary efficacy regarding quality of life (QOL) outcomes. METHOD: In this single-arm feasibility trial, patients with lung cancer undergoing radiotherapy and their caregivers participated in a 15-session VKC program that focused on the interconnectedness of the dyad. We assessed pre-and post-intervention levels of fatigue, sleep disturbances, psychological distress, overall QOL, spirituality, and relational closeness. We tracked feasibility data, and participants completed program evaluations. RESULTS: We approached 28 eligible dyads of which 15 (53%) consented and 9 (60%) completed the intervention. Patients (mean age = 73 years, 63% female, all stage III) and caregivers (mean age = 62 years, 38% female, 63% spouses) completed a mean of 10 sessions and 95.5% of them rated the program as very useful. Paired t tests revealed a significant increase in patients' mental health (d = 0.84; P = .04) and a significant decrease in caregivers' sleep disturbances (d = 1.44; P = .02). Although not statistically significant, for patients, effect sizes for change scores were medium for benefit finding and small for distress (d = 0.65 and 0.37, respectively). For caregivers, medium effects were found for improvement in physical functioning (d = 0.50). CONCLUSION: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for lung cancer patients and their caregivers and lends support for further study.