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Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.

ABSTRACT: BACKGROUND:It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment. METHODS:The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ?5 are randomized to the intervention or control group while patients scoring ?4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2?weeks and 3, 6, 9 and 12?months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated. DISCUSSION:This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice. TRIAL REGISTRATION:ClinicalTrials.gov NCT03434717. Registered February 15, 2018.

SUBMITTER: Olsson Moller U

PROVIDER: S-EPMC7257149 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.

Olsson Möller U U Rydén L L Malmström M M

BMC cancer 20200529 1

<h4>Background</h4>It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effec ...[more]

PMID: 32471390

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Project description:BackgroundFor years it has been stated that the need for prevention and rehabilitation is not always identified early enough. Although many individuals have regular contact with a general practitioner (GP), this access path for applying for a prevention or rehabilitation service has not been fully exploited. The important role of GPs in supporting the intention to apply is highlighted in the research. This study aims to evaluate the effectiveness of the "check-up 45 + " to support GPs both in identifying the need for prevention and rehabilitation services and in submitting applications.MethodsThe study is designed as a two-arm, pragmatic 1:1 randomised controlled study (RCT), which will be conducted in about 20 general practices in the German states of Berlin and Brandenburg. Patients (n = 1,654) aged from 45 to 59 years will be recruited by medical assistants. In addition to usual care, both study groups will receive a questionnaire covering socio-economic and occupational variables to be filled out immediately in the waiting room. The intervention group passes through the "check-up 45 + ". This includes the completion of the "screening 45 + " that aims to assess the need for prevention and rehabilitation services. Medical assistants will immediately evaluate this 2-page screening tool. If a need is identified and confirmed by the GP, information and application documents will be handed over. Moreover, the application process for rehabilitation services is simplified. Primary outcome is the proportion of applications for prevention or rehabilitation services financed by the German Pension Insurance. Administrative data will be provided for this purpose. Secondary outcomes include the proportion of approved applications and completed services. In addition, the proportion of persons with a need for prevention or rehabilitation according to the "check-up 45 + " will be examined. Semi-structured interviews will be conducted and content-analysed to determine the practicability and acceptance of the "check-up 45 + " by the relevant stakeholders.DiscussionPrevention and rehabilitation need is insufficiently identified and addressed so far. This study will determine the effectiveness of the "check-up 45 + " in primary care.Trial registrationGerman Clinical Trials Register (DRKS00028303, 03.03.2022).

Project description:BackgroundCurative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver.MethodsThe ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed.DiscussionThis RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors.Trial registrationThe study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

Project description:BackgroundThere are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management.MethodsThis randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results.DiscussionThis study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination.Trial registrationThe study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

Project description:BackgroundPatients newly diagnosed with breast cancer face a series of complex decisions regarding locoregional and systemic treatment. There is a need to improve the quality of locoregional and systemic decisions for breast cancer patients, and to help patients understand the role of evaluative tests in this decision process. We are now conducting a randomized controlled trial (RCT) of an online decision tool-called iCanDecide, which we expect will help patients with these difficult decisions. Furthermore, the results of this RCT will be highly relevant to future breast cancer patients making these decisions and to their clinicians.MethodsThis is a two-arm randomized controlled trial with the target of 222 participants per arm. Participants are recruited from 25 surgical practices (total 40 surgeons) and 2 medical oncology practices (total 2 oncologists) in Michigan, Georgia, Tennessee, and California. Participants are newly-diagnosed female breast cancer patients between 21 and 84 years, with stage I-II invasive breast cancer or ductal carcinoma in situ (DCIS) and who are eligible for and considering either mastectomy or lumpectomy with radiation, and who may be eligible for adjuvant systemic treatment.The RCT tests an interactive, tailored website, called iCanDecide (intervention arm), compared to a static version of the website (control arm). The static control arm is designed to include the same basic content as the intervention version, but without tailoring and interactive features. The primary outcome includes the rate of making a high-quality decision. The hypothesis is that patients randomized to the interactive version of iCanDecide will have higher rates of high quality decisions (informed and values-concordant), and will appraise their decision-making process more positively, for both surgical and systemic treatment.DiscussionThe goal of this study is to evaluate the impact of the iCanDecide interactive website on decision-making for locoregional and systemic breast cancer treatments. The results of this study will be important for future breast cancer patients and their clinicians as we determine how to better individualize decision making across this complex treatment landscape.

Project description:Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.www.ClinicalTrials.gov Identifier: NCT00871715

Project description:BackgroundShort message service (SMS) based interventions are widely used in healthcare and have shown promising results to improve cancer screening programs. However, more research is still needed to implement SMS in the screening process. We present a study protocol to assess the impact on health and economics of three targeted SMS-based interventions in population-based cancer screening programs.Methods/designThe M-TICs study is a randomized controlled trial with a formal process evaluation. Participants aged 50-69 years identified as eligible from the colorectal cancer (CRC) and breast cancer (BC) screening program of the Catalan Institute of Oncology (Catalonia, Spain) will be randomly assigned to receive standard invitation procedure (control group) or SMS-based intervention to promote participation. Two interventions will be conducted in the CRC screening program: 1) Screening invitation reminder: Those who do not participate in the CRC screening within 6 weeks of invite will receive a reminder (SMS or letter); 2) Reminder to complete and return fecal immunochemical test (FIT) kit: SMS reminder versus no intervention to individuals who have picked up a FIT kit at the pharmacy and they have not returned it after 14 days. The third intervention will be performed in the BC screening program. Women who had been screened previously will receive an SMS invitation or a letter invitation to participate in the screening. As a primary objective we will assess the impact on participation for each intervention. The secondary objectives will be to analyze the cost-effectiveness of the interventions and to assess participants' perceptions.Expected resultsThe results from this randomized controlled trial will provide important empirical evidence for the use of mobile phone technology as a tool for improving population-based cancer screening programs. These results may influence the cancer screening invitation procedure in future routine practice.Trial registrationRegistry: NCT04343950 (04/09/2020); clinicaltrials.gov.

Project description:Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block.This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay.Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients.Clinicaltrials.gov NCT01398982.

Project description:BackgroundThere is individual variability to cardiorespiratory fitness (CRF) training, but the underlying cause is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relative percentages of maximal heart rate, heart rate reserve (HRR), maximal oxygen uptake (VO2max), or VO2 reserve to establish exercise intensity. However, this model fails to take into consideration individual metabolic responses to exercise and may attribute to the variability in training responses. It has been proposed that an individualized approach would take into consideration metabolic responses to exercises to increase responsiveness to training.MethodsIn this randomized control trial, participants will undergo a 12-week exercise intervention using individualized (ventilatory thresholds) and standardized (HRR) methods to prescribe CRF training intensity. Following the intervention, participants will be categorized as responders or non-responders based on changes in maximal aerobic abilities. Participants who are non-responders will complete a second 12-week intervention in a crossover design to determine whether they can become responders with a differing exercise prescription. There are four main research outcomes: (1) determine the cohort-specific technical error to use in the categorization of response rate; (2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO2max and cardiometabolic risk factors; (3) investigate the time course changes throughout 12 weeks of CRF training between the two intervention groups; and (4) determine if non-responders can become responders if the exercise prescription is modified.DiscussionThe findings from this research will provide evidence on the effectiveness of individualized exercise prescription related to training responsiveness of VO2max and cardiometabolic risk factors compared to a standardized approach and further our understanding of individual exercise responses. If the individualized approach proposed is deemed effective, it may change the way exercise specialists prescribe exercise intensity to enhance training responsiveness.Trial registrationClinicalTrials.gov, NCT02868710 . Registered on 15 August 2016.

Project description:BackgroundCardiac rehabilitation after acute myocardial infarction permits recovery of the heart function and enables secondary prevention programs in which changes in lifestyle habits are crucial. Cardiac rehabilitation often takes place in hospitals without coordination with primary healthcare and is not focused on individual patient preferences and goals, which is the core of the motivational interview. The objective of this study was to evaluate the efficacy of a cardiac rehabilitation program with a motivational interview in patients discharged from hospital after acute myocardial infarction.Methods/designA randomized, non-pharmacological clinical trial in six primary healthcare centers in Barcelona (Spain) will assess whether a tailored cardiac rehabilitation program consisting of four motivational interviews and visits with family physicians, primary healthcare nurses and a cardiologist, coordinated with the reference hospital, results in better cardiac rehabilitation than standard care. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction will be randomized to a cardiac rehabilitation group with a motivational interview program or to standard primary healthcare. The main outcome will be physical function measured by the six-minute walk test, and the secondary outcome will be the effectiveness of secondary prevention: a composite outcome comprising control of blood pressure, cholesterol, diabetes mellitus, smoking and body weight. Results will be evaluated at 1,3 and 6 months.DiscussionThis is the first clinical trial to study the impact of a new primary healthcare cardiac rehabilitation program with motivational interviews for patients discharged from hospital after myocardial infarction. Changes in lifestyles and habits after myocardial infarction are a core element of secondary prevention and require patient-centered care strategies such as motivational interviews. Therefore, this study could clarify the impact of this approach on health indicators, such as functional capacity.Trial registrationClinicalTriasl.gov NCT05285969 registered on March 18, 2022.

Project description:BackgroundLoss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non-free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD.ObjectiveThis study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms.MethodsIn this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months.ResultsEthical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.ConclusionsThe purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management.Trial registrationClinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381.International registered report identifier (irrid)DERR1-10.2196/33104.

Dataset Information

Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.

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Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.

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