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A randomised controlled trial of an intervention to promote early presentation of breast cancer in older women: effect on breast cancer awareness.

ABSTRACT: 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.

SUBMITTER: Linsell L

PROVIDER: S-EPMC2790707 | biostudies-other | 2009 Dec

REPOSITORIES: biostudies-other

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Project description:IntroductionExercise interventions have been widely investigated in patients with cancer and demonstrate beneficial effects. However, intervention studies that include older women with breast cancer exercising during medical treatment are scarce. Hence, the aim of this study is to investigate the effect of a 12-week exercise-based intervention in older women (≥65 years) with breast cancer receiving (neo)adjuvant or first-line or second-line systemic therapy.Methods and analysisThis is a single-centre, two-armed randomised controlled trial. We anticipate including 100 patients, who will be randomised 1:1 to exercise-based intervention or control stratified by treatment setting ((neo)adjuvant or metastatic) and treatment (chemotherapy or endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitors). The intervention group will receive standard oncological treatment and a 12-week supervised exercise-based intervention comprising a progressive resistance exercise programme two times per week, a protein supplement after exercise and a home-based walking programme based on daily step counts. The control group will receive standard oncological treatment. Assessments will be performed at baseline and 6, 12 and 24 weeks after start of the intervention. Primary outcome is physical function, measured by the 30-second Chair Stand Test. Secondary outcomes are feasibility (compliance and adherence to intervention), objective and patient-reported functional measures (6-meter and 10-meter gait speed; 6-min Walk Test; Handgrip Strength; Stair Climb Test; Physical Activity Questionnaire), symptom burden and well-being (MD Anderson Symptom Inventory; Hospital Anxiety and Depression Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and B23), body composition (dual-energy X-ray absorptiometry scan), side effects, inflammatory biomarkers, hospitalisation and survival.Ethics and disseminationThe protocol was reviewed and accepted by the Scientific Ethics Review Committee of the Capital Region of Denmark, 17 June 2018 (VEK ref.: H-18021013). Trial results will be submitted for publication in a peer-reviewed journal and presented on conferences, in oncology wards, exercise centres in municipalities and patient organisations, ensuring dissemination to relevant stakeholders.Trial registration numberhttps://clinicaltrials.gov/ on 3 September 2018. Identifier: NCT03656731.

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.

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.

Project description:The aim of this comparative, effectiveness trial was to evaluate the safety, feasibility and effect of an exercise intervention delivered via low-level versus high-level supervision. The target population were women who were diagnosed with ≥stage II breast cancer, had ≥ one comorbidity and/or persistent treatment-related side-effects, and were insufficiently physically active. Sixty women (50 ± 9 years) were randomized to the low-supervision group (n = 30) or high-supervision group (n = 30). The low-supervision group participated in a 12-week, individually-tailored exercise intervention supported by five supervised sessions with an exercise professional. The high-supervision group participated in the same exercise intervention but received 20 supervised sessions across the 12-week period. The target weekly dosage of 600 metabolic equivalent minutes of exercise per week (MET-mins/wk) and the session content, such as safety and behaviour change topics, were standardized between the groups. The primary outcomes were intervention safety, defined as the number, type, and severity of exercise-related adverse events (e.g., musculoskeletal injury or exacerbated treatment-related side effects), and feasibility, which was defined as compliance to target exercise dosage. The effect of the intervention on quality of life, physical activity, self-efficacy, fitness, and strength was also assessed (pre- and post-intervention, and at 12-week follow-up). The intervention was safe, with no exercise-related adverse events of grade 3 or above in either group. Both groups reported high compliance to the target exercise dosage (median MET-mins/wk: High = 817; Low = 663), suggesting the exercise intervention was feasible, irrespective of supervision level. Improvements in quality of life, physical activity and fitness were observed post-intervention and maintained at follow-up for both groups (p < 0.05). Only the high-supervision group showed clinically-relevant improvements in strength and self-efficacy at post-intervention (p < 0.05). Individually-targeted exercise delivered under high- or low-levels of supervision is safe, feasible and beneficial for women with stage II+ breast cancer. Future research needs to assess whether the greater gains observed in the group who received higher supervision may contribute to longer term maintenance of physical activity levels and overall health benefits. Australian and New Zealand Clinical Trials Registry: ACTRN12616000547448.

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A randomised controlled trial of an intervention to promote early presentation of breast cancer in older women: effect on breast cancer awareness.

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