A randomised controlled trial of a psychoeducational intervention for women at increased risk of breast cancer.
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ABSTRACT:
SUBMITTER: Appleton S
PROVIDER: S-EPMC2395330 | biostudies-other | 2004 Jan
REPOSITORIES: biostudies-other
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Project description:There is virtually no evidence for the effectiveness of interventions to promote early presentation in breast cancer. We aimed to test the efficacy of an intervention to equip older women with the knowledge, skills, confidence and motivation to detect symptoms and seek help promptly, with the aim of promoting early presentation with breast cancer symptoms.We randomised 867 women aged 67-70 years attending for their final routine appointment on the UK NHS Breast Screening Programme to receive: a scripted 10-min interaction with a radiographer plus a booklet, a booklet alone or usual care. The primary outcome was whether or not a woman was breast cancer aware based on knowledge of breast cancer symptoms and age-related risk, and reported breast checking.At 1 month, the intervention increased the proportion who were breast cancer aware compared with usual care (interaction arm: 32.8% vs 4.1%; odds ratio (OR): 24.0, 95% confidence interval (CI): 7.7-73.7; booklet arm: 12.7% vs 4.1%; OR: 4.4, 95% CI: 1.6-12.0). At 1 year, the effects of the interaction plus booklet, and the booklet, on breast cancer awareness were largely sustained, although the interaction plus booklet remained much more effective.An intervention to equip older women with the knowledge, skills, confidence and motivation to detect breast cancer symptoms and seek help promptly increases breast cancer awareness at 1 year. Future research will evaluate whether the intervention promotes early presentation and reduces breast cancer mortality.
| S-EPMC2790707 | biostudies-other
Project description:ObjectiveCombining 3rd-wave-therapies with Cognitive-Behavioural-Therapy (CBT) has increased in recent years. Usually these therapies require longer sessions which therefore increases the psychotherapy drop-out rate for cancer patients for multiple medical reasons. This inspired intervention of a shorter 20 min-long mindfulness-therapy (MBST) to be developed for Breast-Cancer-patients (BC).MethodThis pilot randomised controlled trial was to assess the immediate-outcome of the MBST-intervention for its efficacy for BC-patients by using the Pearson Chi-square test, Fisher-Freeman-Halton exact test, and McNemar test for categorical variables; Mann-Whitney U and Wilcoxon test for the continuous variables. The Emotion Thermometer, State Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, Self-Efficacy for Managing Chronic Disease, and Beck's Hopelessness Scale were used for measuring the intervention outcomes. One hundred seventy-three BC patients were randomly assigned in two-groups (equal-mean-age, p = 0.417). Control-Group (CG, n = 82) received cognitive-disputation-technique a form-of-CBT, and Intervention-Group (IG, n = 74) received MBST. The directives are given to IG: psychoeducation about Mindfulness, and to imagine themselves swinging-in a peaceful environment. When the patients imagine their swing going up, they physically take a deep-breath, and when going down they physically release their breath, and this process is repeated.ResultOutcomes post-treatment showed significant higher-improvement in IG in all the assessed-measurements, with large-effect-size: anxiety (p < 0,05, r = 0,67) and depression-levels (p < 0,05, r = 0,71); anxiety-trait (p < 0,05; r = 0,79) reduced, it increases self-efficacy for managing-disease (p < 0,05, r = 0,82) as-well-as hopefulness (p < 0,05, r = 0,61) and saturation-level measured by pulse-meter/oximeter (p < 0,05, r = 0,51).ConclusionMBST is an efficacious intervention to reduce psychotherapy session time for immediate relief from clinical anxiety and hopelessness as well as increase self-efficacy and improve tranquillity for BC-women. It may have a particular clinical significance for supporting patient's adherence to treatment. Although in this pilot sample MBST was found to be effective for short-term-outcome, its efficacy for longer-term-outcome should be examined in future trials. Additionally, breathing laps can be increased possibly for a greater result on rise of saturation levels of patients.
| S-EPMC9291217 | biostudies-literature
Project description:This SuperSeries is composed of the SubSeries listed below. Gene expression profiling of continuous or intermittent energy restriction in women at increased risk of breast cancer
2016-07-13 | GSE66162 | GEO
Project description:We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.Prospective, pragmatic, individually randomised controlled trial.3 Maternity Trusts in West Midlands, UK.Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems.Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes.This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.ISRCTN35027323; Results.
| S-EPMC4785315 | biostudies-other
Project description:Addressing psychosocial and quality of life needs is central to provision of excellent care for people with advanced cancer. This study tested a brief nurse-delivered intervention to address the needs of urban women with advanced breast cancer. This study was conducted at four large urban hospitals in Australia. One hundred and five women with advanced breast cancer were recruited and randomised to receive the intervention or usual care, then asked to complete the European Organisation of Research and Treatment of Quality of life Q-C30 version (2.0) (EORTC Q-C30) (version 2) and Supportive Care Needs Survey (SCNS) at 1 month and 3 months postrecruitment. No significant differences were detected between intervention and usual care groups in the SCNS or the EORTC Q-C30 subscale scores. However, when the groups were divided into high needs (score of above 50) and low baseline needs (score of 50 or below) for each SCNS subscale, a significant difference between intervention and usual care groups was found in the psychological/emotional subscale among women with high baseline needs. In conclusions, this study demonstrated that a face-to-face session and follow-up phone call with a breast care nurse significantly reduced the psychological and emotional needs of those with high initial needs. There was no evidence of the intervention influencing the quality of life; or perceived needs of women with low initial psychological/emotional needs or perceived needs in other domains. Possibly, the intervention was not sufficiently intense to achieve an effect.
| S-EPMC2360523 | biostudies-other
Project description:To investigate the effects of a multimodal couple-based sexual health intervention for premenopausal women treated for breast cancer and their partners to provide personalised psychosexual care, and to understand participants' experience of, and adherence to, the intervention. This is an assessor-blinded, randomised controlled trial. Premenopausal women treated for breast cancer (N = 160) and their partners will be recruited. Dyads will be randomised into an intervention (n = 80) or attention control (n = 80) group. The intervention group will receive the multimodal couple-based sexual health intervention over eight weeks. The intervention comprises five face-to-face and virtual individual couple counselling sessions combined with online reading, a chat-based discussion forum, and telephone calls. The intervention is based on level I-II evidence and a robust theoretical framework. The attention control group will receive usual care plus telephone calls comprising general greetings and reminders to complete follow-up surveys. Sexual adjustment, relationship quality and quality of life will be measured at baseline, after completion of the intervention, three months and six months post-intervention. The project will adhere to the CONSORT-EHEALTH checklist. Qualitative interviews will explore the participants' experience of, and adherence to, the intervention. This study will provide the first pragmatic evidence of the effectiveness of a multimodal couple-coping intervention to support premenopausal women and their partners to improve sexuality, relationship quality and quality of life after treatment for breast cancer. Sexual health is a neglected area in clinical practice, for patients and partners. The ever-growing population of women treated for breast cancer at younger age has created a more pressing need for the development of tailored sexual health interventions. If effective, this intervention could be incorporated into routine cancer care to provide better support and care for this patient population to enhance sexual health, intimacy and overall well-being. ISRCTN35481498; prospectively registered on 08/05/2023.
| S-EPMC11340947 | biostudies-literature
Project description:Women with breast cancer undergoing chemotherapy suffer from a range of detrimental disease and treatment related side-effects. Exercise has shown to be able to counter some of these side-effects and improve physical function as well as quality of life. The primary aim of the study is to investigate and compare the effects of two different exercise regimens on the primary outcome cancer-related fatigue and the secondary outcomes muscle strength, function and structure, cardiovascular fitness, systemic inflammation, skeletal muscle gene activity, health related quality of life, pain, disease and treatment-related symptoms in women with breast cancer receiving chemotherapy. The second aim is to examine if any effects are sustained 1, 2, and 5 years following the completion of the intervention and to monitor return to work, recurrence and survival. The third aim of the study is to examine the effect of attendance and adherence rates on the effects of the exercise programme.This study is a randomised controlled trial including 240 women with breast cancer receiving chemotherapy in Stockholm, Sweden. The participants are randomly allocated to either: group 1: Aerobic training, group 2: Combined resistance and aerobic training, or group 3: usual care (control group). During the 5-year follow-up period, participants in the exercise groups will receive a physical activity prescription. Measurements for endpoints will take place at baseline, after 16 weeks (end of intervention) as well as after 1, 2 and 5 years.This randomised controlled trial will generate substantial information regarding the effects of different types of exercise on the health of patients with breast cancer undergoing chemotherapy. We expect that dissemination of the knowledge gained from this study will contribute to developing effective long term strategies to improve the physical and psychosocial health of breast cancer survivors.OptiTrain - Optimal Training Women with Breast Cancer (OptiTrain), NCT02522260 ; Registration: June 9, 2015, Last updated version Feb 29, 2016. Retrospectively registered.
| S-EPMC5294772 | biostudies-literature
Project description:Background: Maternal blood folate concentrations during pregnancy have been previously linked with DNA methylation patterns, but this has been done predominantly through observational studies. We showed recently in an epigenetic analysis of the first randomized controlled trial (RCT) of folic acid supplementation specifically in the second and third trimesters (the EpiFASSTT trial) that methylation at some imprinted genes was altered in cord blood samples in response to treatment. Here, we report on epigenome-wide screening using the Illumina EPIC array (~ 850,000 sites) in these same samples (n = 86). Results: The top-ranked differentially methylated promoter region (DMR) showed a gain in methylation with folic acid (FA) and was located upstream of the imprint regulator ZFP57. Differences in methylation in cord blood between placebo and folic acid treatment groups at this DMR were verified using pyrosequencing. The DMR also gains methylation in maternal blood in response to FA supplementation. We also found evidence of differential methylation at this region in an independent RCT cohort, the AFAST trial. By altering methylation at this region in two model systems in vitro, we further demonstrated that it was associated with ZFP57 transcription levels. Conclusions: These results strengthen the link between folic acid supplementation during later pregnancy and epigenetic changes and identify a novel mechanism for regulation of ZFP57. This trial was registered 15 May 2013 at www.isrctn.com as ISRCTN19917787. Ethics approval and consent to participate: The Office for Research and Ethics Committees Northern Ireland (ORECNI) granted ethical approval (reference 05/ Q2008/21) and each participant gave written informed consent upon recruitment.
2021-06-08 | GSE176325 | GEO
Project description:To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), and blood biomarkers in breast cancer survivors.Eighty post-adjuvant therapy invasive breast cancer patients (age = 53.6 ± 9.4 years; height = 161.2 ± 6.8 cm; mass = 68.7 ± 10.5 kg) were randomly allocated to a 6-month home-based PA intervention or usual care. The intervention group received face-to-face and telephone PA counselling aimed at encouraging the achievement of current recommended PA guidelines. All patients were evaluated for our primary outcome, PA (International PA Questionnaire) and secondary outcomes, mass, BMI, body fat %, HRQoL (Functional assessment of Cancer Therapy-Breast), insulin resistance, triglycerides (TG) and total (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) cholesterol were assessed at baseline and at 6-months.On the basis of linear mixed-model analyses adjusted for baseline values performed on 40 patients in each group, total, leisure and vigorous PA significantly increased from baseline to post-intervention in the intervention compared to usual care (between-group differences, 578.5 MET-min?wk(-1), p =?.024, 382.2 MET-min?wk(-1), p =?.010, and 264.1 MET-min?wk(-1), p =?.007, respectively). Both body mass and BMI decreased significantly in the intervention compared to usual care (between-group differences, -1.6 kg, p =?.040, and -.6 kg/m(2), p =?.020, respectively). Of the HRQoL variables, FACT-Breast, Trial Outcome Index, functional wellbeing, and breast cancer subscale improved significantly in the PA group compared to the usual care group (between-group differences, 5.1, p =?.024; 5.6, p =?.001; 1.9 p =?.025; and 2.8, p =?.007, respectively). Finally, TC and LDL-C was significantly reduced in the PA group compared to the usual care group (between-group differences, -.38 mmol?L(-1), p =?.001; and -.3 mmol?L(-1), p =?.023, respectively).We found that home-based PA resulted in significant albeit small to moderate improvements in self-reported PA, mass, BMI, breast cancer specific HRQoL, and TC and LDL-C compared with usual care. CLINICALTRIALS.NCT02408107 (March 25, 2015).
| S-EPMC4797234 | biostudies-literature
Project description:Lymphocyte and breast tissue samples from overweight woman at increased risk of breast cancer before and after 1 month of intermittant energy restriction Introduction Observational studies indicate that weight loss and energy restriction reduce breast cancer risk. Intermittent energy restriction (IER) reduces weight as well as, or more than continuous energy restriction (CER), but its effect on the breast and systemic metabolism as indicators of breast cancer risk are not known. Methods We assessed the effect of IER ( 2 days of 65% energy restriction) for one menstrual cycle on the breast (breast gene expression and fat cell size) and systemic metabolism (insulin resistance, lipids, serum and urine metabolites) in 23 overweight premenopausal women at high risk of breast cancer. Unsupervised hierarchical analysis selected 100 genes with the highest variance between pre and post IER biopsies in 20 subjects, whilst mass spectrometry was used to assess corresponding changes in serum (LCMS) and urine metabolites (GCMS) in 23 subjects in the restricted and unrestricted days of the IER. Results Women lost on average 4.8% (± 2.0) of body weight and 8.0% (± 5.0) of body fat. Insulin resistance (HOMA) was reduced by 29.8% (±17.8) on the restricted days and by 11%(±34) on the unrestricted days of the IER. Over 250 serum and urine metabolites significantly increased or decreased during the two restricted days and most returned to normal after the subsequent five day period . In the breast tissue, approximately half (In 11) of the subjects displayed down regulation of several metabolic pathways including lipid synthesis, growth factors and hormones, whilst epithelial genes including milk proteins, secretoglobulins and mucins were up-regulated and several metabolic pathways down-regulated including lipid synthesis, growth factors and hormones. In the other nine subjects there was no appreciable effect of IER on the breast. CorrespondingThe gene changes were not seen in peripheral blood lymphocytes, and there was no reduction in breast fat cell size. The two groups defined by change in gene expression or lack of it did not differ in the degree of weight or fat loss, other systemic metabolic markers, or histological assessment of the biopsies. Conclusion We conclude that breasts vary in response to short-term IER, the mechanism of which requires further investigation. Trial registration ISRCTN77916487
2016-07-13 | GSE66161 | GEO