scholarly journals Multicentre prospective cohort study of unmet supportive care needs among patients with breast cancer throughout their cancer treatment trajectory in Penang: a PenBCNeeds Study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044746
Author(s):  
Noorsuzana Mohd Shariff ◽  
Nizuwan Azman ◽  
Rohayu Hami ◽  
Noor Mastura Mohd Mujar ◽  
Mohammad Farris Iman Leong Bin Abdullah

IntroductionProper assessment of unmet supportive care needs of patients with breast cancer and its influencing factors at different treatment intervals will improve the rehabilitation of patients with breast cancer. Therefore, this study aims to determine the prevalence of unmet supportive care needs, changes of needs over time and associated factors during the treatment period.Methods and analysisThis multicentre, prospective cohort study will be conducted in three governmental hospitals and one tertiary cancer institute in Penang, Malaysia. Adult women diagnosed with primary or recurrent tumour, node, metastases stage I–IV breast cancer based on pathological biopsy will be eligible for this study. At least 281 samples are required for this study. Participants will undergo follow-up at three time intervals: T1 at breast cancer diagnosis; T2 at 3 months after diagnosis and T3 at 6 months after diagnosis. Patients will complete a set of questionnaires at each time. The primary outcome of this study includes the changes in supportive care needs over three time points, followed by the secondary outcome examining patients’ characteristics, coping behaviours and positive psychological components as they affect changes in unmet supportive care needs over time.Ethics and disseminationThe study has received ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-19-268-45809 IIR) and the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/17100443). The results of the prospective study will be submitted for publication in a peer-reviewed journal.

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038681
Author(s):  
Imran Ahmed ◽  
Mike Bowes ◽  
Charles E Hutchinson ◽  
Nicholas Parsons ◽  
Sophie Staniszewska ◽  
...  

IntroductionThis study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail.Methods and analysisThis is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months.Ethics and disseminationThe study obtained approval from the National Research Ethics Committee West Midlands—Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication.Trial registration numberUHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18–19


2002 ◽  
Author(s):  
A. R. Aro ◽  
H. J. de Koning ◽  
K. Vehkalahti ◽  
P. Absetz ◽  
M. Schreck ◽  
...  

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Heidemarie Haller ◽  
Petra Voiß ◽  
Holger Cramer ◽  
Anna Paul ◽  
Mattea Reinisch ◽  
...  

Abstract Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. Trial registration German Clinical Trial Register DRKS00014852. Retrospectively registered at July 4th, 2018.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040817
Author(s):  
Patrick O'Byrne ◽  
Amanda Vandyk ◽  
Lauren Orser ◽  
Marlene Haines

ObjectiveTo report the results of a nurse-led pre-exposure prophylaxis (PrEP) delivery service.DesignThis was a prospective cohort study conducted from 5 August 2018 to 4 March 2020. It involved manual chart review to collect data. Variables were described using frequencies and percentages and analysed using χ2 testing. Those significant in bivariate analysis were retained and entered into a binary multiple logistic regression. Hierarchical modelling was used, and only significant factors were retained.SettingThis study occurred in an urban public health unit and community-based sexually transmitted infection (STI) clinic in Ottawa, Canada.ParticipantsOf all persons who were diagnosed with a bacterial STI in Ottawa and everyone who presented to our STI clinic during the study period, there were 347 patients who met our high-risk criteria for PrEP; these criteria included patients who newly presented with any of the following: HIV contacts, diagnosed with a bacterial STI or single use of HIV PEP. Further, eligibility could be determined based on clinical judgement. Patients who met the foregoing criteria were appropriate for PrEP-RN, while lower-risk patients were referred to elsewhere. Of the 347 patients who met our high-risk criteria, 47% accepted and 53% declined. Of those who accepted, 80% selected PrEP-registered nurse (RN).Primary and secondary outcome measuresUptake, acceptance, engagement and attrition factors of participants who obtained PrEP through PrEP-RN.Findings69% of participants who were eligible attended their intake PrEP-RN visit. 66% were retained in care. Half of participants continued PrEP and half were lost to follow-up. We found no significant differences in the uptake, acceptance, engagement and attrition factors of participants who accessed PrEP-RN regarding reason for referral, age, ethnicity, sexual orientation, annual income, education attainted, insurance status, if they have a primary care provider, presence or absence of depression or anxiety and evidence of newly acquired STI during the study period.ConclusionsNurse-led PrEP is an appropriate strategy for PrEP delivery.


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