Dataset Information

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

ABSTRACT: BACKGROUND:Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. METHODS:This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. DISCUSSION:There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice. TRIAL REGISTRATION:ISRCTN 12824632 . Registered 25-01-2017.

SUBMITTER: Fenlon D

PROVIDER: S-EPMC5941327 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

Fenlon Deborah D Nuttall Jacqueline J May Carl C Raftery James J Fields Jo J Kirkpatrick Emma E Abab Julia J Ellis Mary M Rose Taylor T Khambhaita Priya P Galanopoulou Angeliki A Maishman Tom T Haviland Jo J Griffiths Gareth G Turner Lesley L Hunter Myra M

BMC women's health 20180508 1

<h4>Background</h4>Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women ...[more]

PMID: 29739384

Similar Datasets

Project description:ObjectivesHot flushes and night sweats (HF/NS) are experienced by 60-70% of menopausal women and are problematic for approximately 20-25%. Potential health risks associated with hormone-replacement therapy (HT) have led to a significant decline in HT use. There is therefore a need for safe, effective and evidence-based alternative treatments for menopausal symptoms. Previous exploratory work suggests that cognitive-behavioural therapy (CBT) is acceptable and effective for women with HF/NS during natural menopause and following breast-cancer treatment. This randomised controlled trial compares the effectiveness of Group CBT and Guided Self-Help CBT with no treatment control in reducing HF/NS Problem Rating and Frequency at post-treatment (main outcome) and at 6 months postrandomisation.Methods and analysis120 women, with 10 or more HF/NS a week for a month, are recruited from GP surgeries and the local community of South London. They are randomised to either 4 weeks of Group CBT, 4 weeks guided Self-Help CBT or no treatment control. Participants attend a clinical interview, and complete baseline questionnaire measures of HF/NS Problem Rating and Frequency (primary outcomes), mood, quality of life, self-esteem, hot-flush beliefs and behaviours, optimism and somatic amplification, and undergo 24 h sternal skin conductance monitoring (SCC-physiological measure of HF/NS) (secondary outcomes). Post-treatment measures (SSC, questionnaires and use of medical services) are collected 6-8 weeks later and follow-up measures (questionnaires and a use of medical services measure) at 6 months postrandomisation.Ethics and disseminationEthical registration was granted by King's College London Research Ethics Committee (ref: PNM/08/09-42). All participants provide written informed consent. If treatment is successful, a Group CBT training manual and training sessions for health professionals, and a Self-Help CBT book will be published. Other CBT delivery options will also be examined (including Computerised Self-Help CBT and Group CBT workshops). Clinical Trial Registration Number ISRCTN57302613.

Project description:ObjectivesTo examine the effectiveness of group cognitive behavioural therapy (CBT) for postpartum depression (PPD) delivered by public health nurses with little to no previous psychiatric training at improving depression, worry, social support and the mother-infant relationship.MethodsMothers (n = 141) living in Ontario, Canada with Edinburgh Postnatal Depression Scale Scores ≥10 and an infant <12 months of age were randomized to receive nine weekly 2-h sessions of in-person group CBT for PPD delivered by two public health nurses plus treatment as usual (TAU; experimental group) or TAU alone (control group). Primary outcomes were change in EPDS score and current major depressive disorder (Mini International Neuropsychiatric Interview) assessed immediately post-treatment (T2). Secondary outcomes included maternal worry, social support, and quality of the mother-infant relationship. All outcomes were assessed again six months post-treatment (T3).ResultsParticipants in the experimental group had statistically significantly greater reductions in PPD symptoms immediately post-treatment (T2) (B = -5.35, p < 0.01), were more likely to manifest a clinically significant improvement in EPDS scores (≥4 points; OR = 3.44, 95%CI: 1.49-7.94), and no longer have symptoms consistent with current MDD (OR = 5.31, 95% CI: 1.78-15.83). Six months post-treatment (T3), experimental group participants had higher odds of clinically significant PPD improvement (OR = 5.10, 95%CI: 1.89-13.78), while 25% of the experimental group and 70% of remaining control group participants reported current MDD (p < 0.01). Statistically significant improvements in worry and the mother-infant relationship were also observed, decreases maintained at six months post-treatment.ConclusionsPublic health nurses with little to no previous psychiatric training can be trained to deliver effective group CBT for PPD to improve depression, worry, and the mother-infant relationship. Task shifting PPD treatment with group CBT to public health nurses could improve treatment uptake and lead to better outcomes for mothers, families, and the healthcare system.(Trial Registration NCT03039530).

Project description:BackgroundDepressive symptoms in patients with cardiovascular disease (CVD) can lead to increased healthcare use. In a randomized controlled trial (ClinicalTrials.gov, NCT02778074), we reported that a 9-week internet-delivered cognitive behavioural therapy (iCBT) program (n = 72) compared to an online discussion forum (ODF) (n = 72) had moderate to large effect on depression in CVD outpatients. In this secondary analysis, we aimed to describe and compare the effect of iCBT compared to ODF regarding healthcare use and to identify factors impacting healthcare use in these groups.MethodsData on healthcare use were retrieved from care data registries in five hospitals in Southeastern Sweden.ResultsThe year prior to intervention, the iCBT group had a mean of 31 outpatient clinic/primary care contacts per patient compared with 21 contacts the year after. The corresponding numbers for the ODF group were 37 and 25. The decrease was 32 % in both groups and did not differ significantly (p = 0.261 and p = 0.354) between the groups. Regarding hospital admissions, the iCBT group had 0.8 admissions per patient the year before and 0.6 the year after the intervention, a decrease by 25 %, whereas the ODF group had 1.1 and 0.6 admissions respectively, a decrease by 45 %. The difference was not statistically significant (p = 0.270 and p = 0.883) between the groups. Improvement in depressive symptoms post intervention were significantly (Beta = 0.459, p = 0.047) associated with a decrease in number of outpatient contacts in the iCBT group. In the ODF group, better mental health-related quality of life post intervention was significantly (Beta = -0.429, p = 0.045) associated with a decrease in number of hospital admissions.ConclusionReduced depressive symptom scores following intervention were associated with lower outpatient service use, but iCBT was not superior compared to ODF. This implicates that reducing depression in CVD patients, regardless of the type of internet-delivered intervention used, is important since it may reduce healthcare use in these patients.

Dataset Information

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

Publications

MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets