QOLP-17. YOGA THERAPY AS A SUPPORTIVE CARE STRATEGY FOR FAMILY CAREGIVERS OF HIGH GRADE GLIOMA PATIENTS: RESULTS OF 3-ARM PILOT RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi186-vi186
Author(s):  
Kathrin Milbury ◽  
Jing Li ◽  
Shiao-Pei Weathers ◽  
Rosangela Silva ◽  
Stella Snyder ◽  
...  
Keyword(s):  
Supportive Care ◽  
Family Caregivers ◽  
Caregiver Burden ◽  
Financial Burden ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
High Grade Glioma ◽  
Medium Effect ◽  
High Grade ◽  
Medium Effect Size

Abstract BACKGROUND This pilot RCT compared the feasibility and preliminary efficacy of a dyadic versus individual yoga intervention as a supportive care strategy for family caregivers of high grade glioma patients. METHODS Caregivers completed self-reported assessments of QOL (SF-36) and caregiver burden (CRA) and were then randomized to a patient-caregiver dyadic yoga (DY), caregiver yoga (CY) or usual are (UC) arm while patients were undergoing standard radiotherapy. Both yoga programs were delivered over 15 sessions either in-person or via videoconference (Zoom). All groups were re-assessed at the end of treatment and then again 3-months later. RESULTS We consented 76 dyads (59%) and randomized 23 to the DY, 22 to the CY, and 22 to the UC arm. Attendance in the DY was higher than in the CY group (means, DY=12.23, CY=9.00, P=.06, d=.57). Caregivers reported significantly more overall subjective benefit in the CY compared to the DY arm (means, CY=1.39, DY=1.81, P< .05, d=1.45). Caregivers slightly favored the in-person delivery (means, in person: 1.48; zoom: 1.82, P=.10; d=.77). A clinically significant, medium effect size was found for improved QOL in favor of the CY over the DY group (means, CY=49.45, DY=44.45; F=3.58, P=.07; d=.67). Caregivers in the CY group reported less caregiving-related health declines compared to the DY group (means, CY=2.18; DY=2.48; F=4.23, P< .05; d=.42). Caregivers in the CY group reported less caregiving-related financial burden than the UC group (means: CY=2.79; UC=3.21; F=3.32, P=.08; d=.35). CONCLUSION Despite lower attendance, caregivers in the CY arm reported greater subjective overall benefit, experienced better mental QOL and less caregiver burden compared with those in the DY and UC comparison arms. It appears that individual rather than dyadic delivery may be a superior supportive care approach for this vulnerable caregiver population. An adequately powered, larger trial of this intervention strategy is warranted.

Yoga therapy as a supportive care strategy for family caregivers of patients with primary brain tumor: Results of 3-arm pilot randomized controlled trial.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 156-156
Author(s):  
Kathrin Milbury ◽  
Jing Li ◽  
Shiao-Pei S. Weathers ◽  
Rosangela Silva ◽  
Stella Snyder ◽  
...  
Keyword(s):  
Supportive Care ◽  
Family Caregivers ◽  
Caregiver Burden ◽  
Financial Burden ◽  
Controlled Trial ◽  
Intervention Strategy ◽  
High Grade Glioma ◽  
Primary Brain Tumor ◽  
Medium Effect ◽  
Loved One

156 Background: Seeking to address the well-documented burden of caring for a loved one with a high-grade glioma, this pilot RCT compared the feasibility and preliminary efficacy of a dyadic versus individual yoga intervention as a supportive care strategy for family caregivers. Methods: Caregivers completed self-reported assessments of QOL (SF-36) and caregiver burden (CRA) at baseline. Then, patients and caregivers were randomized to either a dyadic yoga (DY) arm in which caregivers attended the sessions together with the patient, a caregiver yoga (CY) arm in which the caregiver attended all sessions individually or a usual care (UC) arm. Both yoga programs were delivered over 15 sessions either in-person or via videoconference (Zoom) concurrently while patients were undergoing standard radiotherapy. All arms were re-assessed at the end of treatment and then again 3-months later. Results: We consented 76 patient-caregiver dyads (59%) and randomized 23 dyads to the DY, 22 to the CY, and 22 to the UC arm. Attendance in the DY was higher than in the CY group (session means, DY = 12.23, CY = 9.00; P =.06, d =.57). Caregivers (80% female; 78% non-Hispanic White; mean age = 53 yrs) reported significantly more overall subjective benefit in the CY compared to the DY arm (means, CY = 1.39, DY = 1.81, P <.05, d = 1.45). Caregivers slightly favored the in-person delivery over the Zoom-based sessions (means, in person: 1.48; Zoom: 1.82, P =.10; d =.77). A clinically significant, medium effect size was found for improved QOL in favor of the CY over the DY group (means, CY = 49.45, DY = 44.45; F = 3.58, P =.07; d =.67). Caregivers in the CY group also reported less caregiving-related health declines compared to the DY group (means, CY = 2.18; DY = 2.48; F = 4.23, P <.05; d =.42). Caregivers in the CY group reported less caregiving-related financial burden than the UC group (means: CY = 2.79; UC = 3.21; F = 3.32, P =.08; d =.35). Conclusions: Despite lower attendance, caregivers in the CY arm reported greater subjective overall benefit, experienced better mental QOL and less caregiver burden compared with those in the DY and UC comparison arms. It appears that individual rather than dyadic delivery may be a superior supportive care approach for this vulnerable caregiver population. An adequately powered, larger efficacy trial of this intervention strategy is warranted. Clinical trial information: NCT02481349.

scholarly journals Yoga Program for High-Grade Glioma Patients Undergoing Radiotherapy and Their Family Caregivers

2017 ◽  
Vol 17 (2) ◽  
pp. 332-336 ◽  
Author(s):  
Kathrin Milbury ◽  
Smitha Mallaiah ◽  
Anita Mahajan ◽  
Terri Armstrong ◽  
Shioa-Pei Weathers ◽  
...  
Keyword(s):  
Supportive Care ◽  
Family Caregivers ◽  
Sleep Disturbances ◽  
Short Form ◽  
Pilot Trial ◽  
High Grade Glioma ◽  
High Grade ◽  
Cancer Symptoms ◽  
Breathing Exercises ◽  
Sf 36

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.

scholarly journals Effect of Anesthesia on The Outcome of High-Grade Glioma Patients Undergoing Supratentorial Resection: Study Protocol for A Randomized Controlled Trial 

2021 ◽  
Author(s):  
Dexiang Wang ◽  
Jia Dong ◽  
Min Zeng ◽  
Xiaoyuan Liu ◽  
Xiang Yan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Tumor Resection ◽  
High Grade Glioma ◽  
High Grade ◽  
Intravenous Anesthesia ◽  
Inhalation Anesthesia ◽  
Randomized Controlled

Abstract Background High-grade glioma (HGG) is the most malignant brain tumor with poor outcome. Whether anesthetic methods have impact on the outcome of these patients is still unknown. Retrospective study has found that there is no difference between two anesthesia methods on the overall survival (OS), however, intravenous anesthesia with propofol might be beneficial in subgroup patients of KPS<80. Further prospective studies are needed to evaluate the results.Methods This is a single-centered, randomized controlled, parallel group trial. 196 patients with primary HGG for tumor resection will be randomly assigned to receive either the intravenous anesthesia with propofol or inhalation anesthesia with sevoflurane. The primary outcome is the OS within 18 months. Secondary outcomes include progression-free survival (PFS), the numerical rating scale (NRS) of pain intensity and sleep quality, the postoperative encephaloedema volume, complications, the length and cost effectiveness of hospital stay of the patients.Discussion This is a randomized controlled trial to compare the effect of intravenous or inhalation anesthesia maintenance on the outcome of supratentorial HGG patients.The results will help to optimizing the anesthesia methods in these patients.Trial registration: ClinicalTrials.gov (ID: NCT02756312). Registered on 27 April 2020 https://register.clinicaltrials.gov/

A randomised controlled trial comparing the effectiveness of different electric breast pumps (Preprint)

2020 ◽  
Author(s):  
Mabel Qi He Leow ◽  
Peter Kay Chai Tay ◽  
Azaizah Binte Mohamed Afif ◽  
Boh Boi Wong ◽  
Lester Chee Hao Leong
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Estimating Equation ◽  
Medium Effect ◽  
Medium Effect Size ◽  
Breast Pump ◽  
Randomised Controlled ◽  
The Impact

BACKGROUND Electric breast pump could be more effective than manual pumps or hand expression of milk. OBJECTIVE This study aims to evaluate the effectiveness of current electric breast pumps, which have additional functions such as massage and ability to vary the rate and pressure. The study will also evaluate the impact of electric pump on breast engorgement, which is a common postpartum complication. METHODS A three-group randomised controlled trial (RCT) will be conducted on Mothers who are breastfeeding and using breast pumps. Adult Mothers who are 21-39 years old will be included. We propose a medium effect size of 0.40 for the study. Taking into account of about 20% dropout rate, 180 participants will be recruited (60 in each group). In addition, 120 control participants who are not using breast pump or not breastfeeding will be recruited. Data collection will include baseline maternal data and clinical data, quantity of expressed milk and duration taken, complications of breast pumping/feeding, and psychosocial data. Quantitative outcomes will be analysed using STATA, using univariate analyses, Pearson’s correlations, generalised estimating equation and two-way ANOVA repeated measures. RESULTS Na CONCLUSIONS Na CLINICALTRIAL Not required

Effect of instrumental support on distress among family caregivers: Findings from a nationally representative study

2020 ◽  
Vol 18 (5) ◽  
pp. 519-527
Author(s):  
Erin E. Kent ◽  
Michelle A. Mollica ◽  
J. Nicholas Dionne-Odom ◽  
Rebecca A. Ferrer ◽  
Roxanne E. Jensen ◽  
...  
Keyword(s):  
Supportive Care ◽  
Family Caregivers ◽  
Caregiver Burden ◽  
Short Form ◽  
Care Recipient ◽  
Instrumental Support ◽  
Caregiver Distress ◽  
Sampling Weights ◽  
Serious Illness ◽  
Nationally Representative

AbstractBackground and ObjectiveA priority focus on palliative and supportive care is helping the 43.5 million caregivers who care for individuals with serious illness. Lacking support may lead to caregiver distress and poorer care delivery to patients with serious illness. We examined the potential of instrumental support (assistance with material and task performance) to mitigate distress among caregivers.MethodWe analyzed data from the nationally representative Health Information National Trends Survey (HINTS V2, 2018). Informal/family caregivers were identified in HINTS V2 if they indicated they were caring for or making healthcare decisions for another adult with a health problem. We used the PROMIS® instrumental support four-item short-form T-scores and the Patient Health Questionnaire (PHQ-4) for distress. We examined multivariable linear regression models for associations between distress and instrumental support, adjusted for sampling weights, socio-demographics, and caregiving variables (care recipient health condition(s), years caregiving (≥2), relationship to care recipient, and caregiver burden). We examined interactions between burden and instrumental support on caregiver distress level.ResultsOur analyses included 311 caregivers (64.8% female, 64.9% non-Hispanic White). The unweighted mean instrumental support T-score was 50.4 (SD = 10.6, range = 29.3–63.3); weighted mean was 51.2 (SE = 1.00). Lower instrumental support (p < 0.01), younger caregiver age (p < 0.04), higher caregiving duration (p = 0.008), and caregiver unemployment (p = 0.006) were significantly associated with higher caregiver distress. Mean instrumental support scores by distress levels were 52.3 (within normal limits), 49.4 (mild), 48.9 (moderate), and 39.7 (severe). The association between instrumental support and distress did not differ by caregiver burden level.ConclusionsPoor instrumental support is associated with high distress among caregivers, suggesting the need for palliative and supportive care interventions to help caregivers leverage instrumental support.

Enhancing quality of life and mastery of informal caregivers of high-grade glioma patients: a randomized controlled trial

2012 ◽  
Vol 111 (3) ◽  
pp. 303-311 ◽  
Author(s):  
Florien W. Boele ◽  
Wopke Hoeben ◽  
Karen Hilverda ◽  
Jeroen Lenting ◽  
Anne-Lucia Calis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
High Grade Glioma ◽  
High Grade ◽  
Randomized Controlled

scholarly journals ‘Make The Connection’ Parenting Skills Program: A Controlled Trial of Associated Improvement in Maternal Attitudes

2018 ◽  
Author(s):  
Amy O'Neill ◽  
Kimberley Swigger ◽  
Valerie Kuhlmeier
Keyword(s):  
Parental Attitudes ◽  
Controlled Trial ◽  
Medium Effect ◽  
Control Group ◽  
Parenting Skills ◽  
Waitlist Control ◽  
Maternal Attitudes ◽  
Health Initiatives ◽  
Medium Effect Size ◽  
Waitlist Control Group

Objective: To assess the effectiveness of Make the Connection (MTC), an attachment focused parent training program, in fostering positive maternal attitudes thought to underlie sensitive responding. Background: Effective early intervention programs for ‘at risk’ parents are likely to promote healthy development and mitigate various negative outcomes associated with insecure attachment in infancy. Negative maternal attitudes and cognitions are thought to underlie insensitive parenting behaviour, and thus constitute a promising target for intervention.Methods: 180 mothers of infants between 3 and 8 months of age were assigned to experimental or waitlist control groups based on program availability in their region. Mothers completed questionnaires assessing parental attitudes at baseline, and again either after participating in MTC or after a 9-week waitlist period.Results: Participants who completed MTC showed significant improvement in overall attitude with a medium effect size relative to the waitlist control group, which showed no change. A small but significant interaction with infant age was noted, such that mothers of younger infants showed slightly more attitude improvement relative to those with older infants. Relative to the control group, participation in Make the Connection was associated with significant improvement in all attitudes except for self efficacy as a parent, which improved with time regardless of program participation.Conclusion: Make the Connection is effective in promoting positive parent-to-infant attachment and is a strong candidate for public health initiatives targeting parenting skills.

scholarly journals QOLP-33. ACCEPTABILITY RANDOMIZED CONTROLLED TRIAL A COUPLES-BASED MIND-BODY INTERVENTION FOR PATIENTS WITH HIGH GRADE GLIOMA AND THEIR PARTNERS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi205-vi205
Author(s):  
Kathrin Milbury ◽  
Shiao- Pei Weathers ◽  
Sania Durrani ◽  
Yisheng Li ◽  
Cindy Carmack ◽  
...  
Keyword(s):  
Intervention Study ◽  
Controlled Trial ◽  
Eligible Patient ◽  
Symptom Burden ◽  
High Grade Glioma ◽  
Emotional Disclosure ◽  
Self Report ◽  
High Grade ◽  
Randomized Controlled ◽  
Couples Coping

Abstract BACKGROUND Given the incurable nature, short survival and high symptom burden of high grade glioma (HGG), patients and their partners are at risk of experiencing psychological and existential/spiritual distress. To address these concerns, we developed a dyadic intervention integrating meditation training with emotional disclosure exercises. The primary aim was to examine feasibility and acceptability of the intervention study procedures. METHODS Dyads completed baseline self-report measures and were randomized to a couple-based mind-body (CBMB) or a waitlist control (WLC) group. Couples in the CBMB groups attended 4 weekly (60 min each) therapist-led sessions that were delivered via FaceTime. The CBMB program focused on cultivating mindfulness, compassion, gratitude and purpose. All groups were reassessed, 1 month and 3 months after baseline. RESULTS We approached 60 eligible patient-partner dyads of which 37 (62%) consented and 18 were randomized to the CBMB and 16 to the WLC group. Of those randomized, 23 dyads (67%) completed all assessments (n= 12 in CBMB; n=11 in WLC). Attrition was due to patients’ death (n=3), symptom burden (n=5) or passive withdrawal (n=3). Patients (57% male; mean age=57 years) and partners’ (59% female; mean age=54 years) attended a mean of 3.17 sessions (SD=1.2) with 83% attending at least 2 sessions. All dyads in the CBMB group reported the intervention as beneficial and useful and would recommend this program to other couples. Of note, 60% of couples would have preferred in-person delivery and 95% of patients but only 33% of partners stated that a dyadic intervention is their preference. CONCLUSION It seems to be feasible, acceptable and possibly efficacious to deliver a dyadic intervention via FaceTime to couples coping with HGG. Although both members of the dyad reported to have benefited, dyadic delivery appears to be less desirable for partners.

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