scholarly journals Mobile Breast Cancer e-Support Program for Chinese Women With Breast Cancer Undergoing Chemotherapy (Part 2): Multicenter Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Jiemin Zhu ◽  
Lyn Ebert ◽  
Xiangyu Liu ◽  
Di Wei ◽  
Sally Wai-Chi Chan

BACKGROUND Women undergoing chemotherapy for the treatment of breast cancer have frequently reported unmet supportive care needs. Moreover, easily accessible and innovative support is lacking. OBJECTIVE The purpose of this trial was to determine the effectiveness of an app-based breast cancer e-support program to address women’s self-efficacy (primary outcome), social support, symptom distress, quality of life, anxiety, and depression. Secondary objectives included exploring the association between women’s health outcomes and the breast cancer e-support usage data. METHODS A multicenter, single-blinded, randomized controlled trial was conducted. A total of 114 women with breast cancer, who were commencing chemotherapy and were able to access internet through a mobile phone, were recruited in the clinics from 2 university-affiliated hospitals in China. Women were randomized either to the intervention group (n=57) receiving breast cancer e-support plus care as usual or the control group (n=57) receiving care as usual alone. The health care team and research assistants collecting data were blinded to the women’s group allocation. Bandura’s self-efficacy theory and the social exchange theory guided the development of the breast cancer e-support program, which has 4 components: (1) a Learning forum, (2) a Discussion forum, (3) an Ask-the-Expert forum, and (4) a Personal Stories forum. Moderated by an experienced health care professional, the breast cancer e-support program supported women for 12 weeks covering 4 cycles of chemotherapy. Health outcomes were self-assessed through paper questionnaires in clinics at baseline before randomization (T0), after 3 (T1), and 6 months (T2) of follow-ups. RESULTS Fifty-five participants in the intervention group and 49 in the control group completed the follow-up assessments (response rate: 91.2%). During the 12-week intervention, the log-in frequency ranged from 0 to 774 times (mean 54.7; SD 131.4; median 11; interquartile range, IQR 5-27), and the total usage duration ranged from 0 to 9371 min (mean 1072.3; SD 2359.5; median 100; IQR 27-279). Repeated measures multivariate analysis of covariance (intention-to-treat) found that breast cancer e-support + care as usual participants had significant better health outcomes at 3 months regarding self-efficacy (21.05; 95% CI 1.87-40.22; P=.03; d=0.53), symptom interference (−0.73; 95% CI −1.35 to −.11; P=.02; d=−0.51), and quality of life (6.64; 95% CI 0.77-12.50; P=.03, d=0.46) but not regarding social support, symptom severity, anxiety, and depression compared with care as usual participants. These beneficial effects were not sustained at 6 months. Spearman rank-order correlation showed that the breast cancer e-support usage duration was positively correlated with self-efficacy (r=.290, P=.03), social support (r=.320, P=.02), and quality of life (r=.273, P=.04) at 3 months. CONCLUSIONS The breast cancer e-support program demonstrated its potential as an effective and easily accessible intervention to promote women’s self-efficacy, symptom interference, and quality of life during chemotherapy. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000639426; www.ANZCTR.org.au/ACTRN12616000639426.aspx (Archived by Webcite at http://www.webcitation.org/6v1n9hGZq)

2013 ◽  
Vol 31 (25) ◽  
pp. 3119-3126 ◽  
Author(s):  
Linda E. Carlson ◽  
Richard Doll ◽  
Joanne Stephen ◽  
Peter Faris ◽  
Rie Tamagawa ◽  
...  

Purpose To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). Patients and Methods This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. Results Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). Conclusion In the largest trial to date, MBCR was superior for improving stress levels, quality of life, and social support for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.


2019 ◽  
Vol 18 ◽  
pp. 153473541987877 ◽  
Author(s):  
Denise M. Millstine ◽  
Anjali Bhagra ◽  
Sarah M. Jenkins ◽  
Ivana T. Croghan ◽  
Daniela L. Stan ◽  
...  

Background: Breast cancer diagnosis and treatment affect quality of life and stress and are associated with fatigue. Meditation interventions are effective strategies for patients with breast cancer but are often limited by poor access, high cost, substantial time commitment, and poor adherence. In this feasibility study, we investigated the use of a portable, wearable, electroencephalographic device for guided meditation practices by breast cancer patients during the period from breast cancer diagnosis until 3 months after surgical treatment. Methods: We enrolled women (age = 20-75 years) who had received a recent diagnosis of breast cancer and planned to undergo surgical treatment. Participants were randomly assigned to perform guided meditation with the device (intervention group) or receive CD-based stress-reduction education (control group). Surveys were used to measure stress, quality of life, and fatigue at baseline, within 4 days before surgery, up to 14 days after surgery, and at 3 months after surgery. Results: In the intervention group, 15 of 17 participants (88.2%) completed the study; in the control group, 13 of 13 participants completed the study (100%). Participants in both groups had less fatigue and stress and improved quality of life at 2 weeks and 3 months after surgery compared with baseline, but there were no significant intergroup differences at any time point. Conclusion: The use of this wearable electroencephalographic device for meditation is a feasible strategy for patients with breast cancer.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Lorenz Imhof ◽  
Susanne Suter-Riederer ◽  
Jürg Kesselring

Background. Multiple sclerosis (MS) or stroke causes functional impairment which can have a major impact on patients’ life. Objectives. This RCT investigated the effect of a new nursing intervention (Mobility Enhancing Nursing Intervention—MFP) designed to improve rehabilitation outcomes. Method. The study took place in a rehabilitation clinic in Switzerland. One hundred forty participants diagnosed with MS, stroke, and brain injuries were randomly assigned to control group (CG = standard care) or intervention group (IG). The IG combined standard care with 30 days of MFB. MFP placed patients on a mattress on the floor and used tactile-kinaesthetic stimulation to increase spatial orientation and independency. Outcomes were functionality (Extended Barthel Index, EBI), quality of life (WHOQoL), and fall-related self-efficacy (FES-I). Results. There was a significant main effect of the intervention on functionality (EBI-diff/day mean = 0.30, versus mean = 0.16, P=0.008). There was also a significant main effect on QoL (WHOQoL-diff mean = 13.8, versus mean = 5.4, P=0.046). No significant effect was observed on fall-related self-efficacy. Conclusions. The positive effect of MFP on rehabilitation outcomes and quality of life suggests that this specialized nursing intervention could become an effective part of rehabilitation programs. The study was approved by the Ethics Committee of St. Gallen (KEK-SG Nr. 09/021) and registered at ClinicalTrial.gov NCT02198599.


2002 ◽  
Vol 9 (4) ◽  
pp. 253-259 ◽  
Author(s):  
Robert L Cowie ◽  
Margot F Underwood ◽  
Cinde B Little ◽  
Ian Mitchell ◽  
Sheldon Spier ◽  
...  

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.


2005 ◽  
Vol 23 (25) ◽  
pp. 6027-6036 ◽  
Author(s):  
Patsy Yates ◽  
Sanchia Aranda ◽  
Maryanne Hargraves ◽  
Bev Mirolo ◽  
Alexandra Clavarino ◽  
...  

PurposeTo evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue.Patients and MethodsThis randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy–Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value.ResultsCompared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy–Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life.ConclusionPreparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.


2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.


2006 ◽  
Vol 24 (4) ◽  
pp. 635-642 ◽  
Author(s):  
Teresa A. Rummans ◽  
Matthew M. Clark ◽  
Jeff A. Sloan ◽  
Marlene H. Frost ◽  
John Michael Bostwick ◽  
...  

Purpose The primary goal of this study was to evaluate the feasibility and effectiveness of a structured, multidisciplinary intervention targeted to maintain the overall quality of life (QOL), which is more comprehensive than psychosocial distress, of patients undergoing radiation therapy for advanced-stage cancer. Patients and Methods Radiation therapy patients with advanced cancer and an estimated 5-year survival rate of 0% to 50% were randomly assigned to either an eight-session structured multidisciplinary intervention arm or a standard care arm. The eight 90-minute sessions addressed the five domains of QOL including cognitive, physical, emotional, spiritual, and social functioning. The primary end point of maintaining overall QOL was assessed by a single-item linear analog scale (Linear Analog Scale of Assessment or modified Spitzer Uniscale). QOL was assessed at baseline, week 4 (end of multidisciplinary intervention), week 8, and week 27. Results Of the 103 participants, overall QOL at week 4 was maintained by the patients in the intervention (n = 49), whereas QOL at week 4 significantly decreased for patients in the control group (n = 54). This change reflected a 3-point increase from baseline in the intervention group and a 9-point decrease from baseline in the control group (P = .009). Intervention participants maintained their QOL, and controls gradually returned to baseline by the end of the 6-month follow-up period. Conclusion Although intervention participants maintained and actually improved their QOL during radiation therapy, control participants experienced a significant decrease in their QOL. Thus, a structured multidisciplinary intervention can help maintain or even improve QOL in patients with advanced cancer who are undergoing cancer treatment.


2020 ◽  
Vol 19 ◽  
pp. 153473542092475
Author(s):  
Julia Ruiz-Vozmediano ◽  
Sarah Löhnchen ◽  
Lucas Jurado ◽  
Rosario Recio ◽  
Andrea Rodríguez-Carrillo ◽  
...  

Background: Integrative oncology has proven to be a useful approach to control cancer symptoms and improve the quality of life (QoL) and overall health of patients, delivering integrated patient care at both physical and emotional levels. The objective of this randomized trial was to evaluate the effects of a triple intervention program on the QoL and lifestyle of women with breast cancer. Methods: Seventy-five survivors of stage IIA-IIB breast cancer were randomized into 2 groups. The intervention group (IG) received a 6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG). Data were gathered at baseline and at 6 months postintervention on QoL and adherence to Mediterranean diet using clinical markers and validated questionnaires. Between-group differences at baseline and 3 months postintervention were analyzed using Student’s t test for related samples and the Wilcoxon and Mann-Whitney U tests. Results: At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05). Dyspnea symptoms were also increased in the CG versus IG ( p = .066). Conclusions: These results demonstrate that an integrative dietary, physical activity, and mindfulness program enhances the QoL and healthy lifestyle of stage IIA-IIB breast cancer survivors. Cancer symptoms may be better managed by the implementation of multimodal rather than isolated interventions.


2007 ◽  
Vol 25 (28) ◽  
pp. 4387-4395 ◽  
Author(s):  
Alyson B. Moadel ◽  
Chirag Shah ◽  
Judith Wylie-Rosett ◽  
Melanie S. Harris ◽  
Sapana R. Patel ◽  
...  

Purpose This study examines the impact of yoga, including physical poses, breathing, and meditation exercises, on quality of life (QOL), fatigue, distressed mood, and spiritual well-being among a multiethnic sample of breast cancer patients. Patients and Methods One hundred twenty-eight patients (42% African American, 31% Hispanic) recruited from an urban cancer center were randomly assigned (2:1 ratio) to a 12-week yoga intervention (n = 84) or a 12-week waitlist control group (n = 44). Changes in QOL (eg, Functional Assessment of Cancer Therapy) from before random assignment (T1) to the 3-month follow-up (T3) were examined; predictors of adherence were also assessed. Nearly half of all patients were receiving medical treatment. Results Regression analyses indicated that the control group had a greater decrease in social well-being compared with the intervention group after controlling for baseline social well-being and covariates (P < .0001). Secondary analyses of 71 patients not receiving chemotherapy during the intervention period indicated favorable outcomes for the intervention group compared with the control group in overall QOL (P < .008), emotional well-being (P < .015), social well-being (P < .004), spiritual well-being (P < .009), and distressed mood (P < .031). Sixty-nine percent of intervention participants attended classes (mean number of classes attended by active class participants = 7.00 ± 3.80), with lower adherence associated with increased fatigue (P < .001), radiotherapy (P < .0001), younger age (P < .008), and no antiestrogen therapy (P < .02). Conclusion Despite limited adherence, this intent-to-treat analysis suggests that yoga is associated with beneficial effects on social functioning among a medically diverse sample of breast cancer survivors. Among patients not receiving chemotherapy, yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL.


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