Neoplasms

All Conditions

Nutritional and Metabolic Diseases

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Carcinoma

Hyperlipoproteinemias

Hyperlipidemias

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Hearing Loss

Deafness

Hearing Disorders

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Dyslipidemias

Metabolic Diseases

Lipid Metabolism Disorders

Antineoplastic Agents

All Drugs and Chemicals

Lipid Regulating Agents

Cisplatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation.

Lisa L Cunningham, Ph.D.

Background:

Cisplatin is a chemotherapy drug. It is used to treat head and neck squamous cell carcinoma (HNSCC) and other cancers. It can cause hearing loss for some people. It is not known how many people will get hearing loss from cisplatin. It is also not known what other factors might influence who gets hearing loss. Factors could include age, sex, noise exposure, and other drugs the person is taking. Statins are drugs used to lower cholesterol. Statins may also reduce cisplatin-induced hearing loss.

Objectives:

To see if statins reduce hearing loss in people getting cisplatin therapy to treat HNSCC. To find out how many people taking cisplatin get hearing loss from it. To find out if other factors might influence whether cisplatin causes hearing loss.

Eligibility:

People ages 18 and older who are getting treatment with cisplatin for HNSCC

Design:

Participants will be screened with a review of their medical records.

Participants will have 3 visits. These will be before the onset of cisplatin therapy, at about 4 weeks after they finish therapy, and about 6 months after they finish therapy. Each visit will include:

Medication history

Audiogram/hearing tests. Participants will wear headphones and indicate when they hear different sounds.

Questions about their noise exposure history and whether they have ringing in the ears

Objectives:

* Primary: Determine whether head and neck cancer patients taking statin drugs for hyperlipidemia are at decreased risk of cisplatin-induced hearing loss.
* Secondary: Determine the incidence and severity of hearing loss in head and neck cancer patients undergoing low-dose, weekly cisplatin chemotherapy with concurrent radiation. Hearing loss with this more recent cisplatin regimen has not been thoroughly evaluated in the literature. Examine whether age, gender, pre-existing hearing loss, other medications, or comorbid medical conditions may be risk factors for cisplatin-induced hearing loss and/or the acquisition or progression of tinnitus in this patient population.

Study Population:

-Subjects will be adult patients with head and neck squamous cell carcinoma of the upper aerodigestive tract who will undergo cisplatin chemotherapy with concurrent radiation.

Design:

* Observational study
* 334 subjects will be enrolled.
* Subjects will complete a questionnaire to estimate the degree of prior noise exposure and impact on baseline hearing. Information on medical comorbidities, names and doses of current medications will be obtained from the medical record and verified at each subject visit.
* Subjects will complete self-administered audiograms using FDA-approved software from SHOEBOXTM Audiometry on a portable tablet (iPad) computer.
* Audiograms will be completed prior to commencing chemoradiation, within 4 weeks of completing treatment, and 6 months after completing treatment.
* Subjects will also complete a validated tinnitus questionnaire with each audiogram. A noise exposure history will be collected during the initial study visit and verified during subsequent visits. Any indicated changes to the subject s noise exposure history will be added to record.
* No investigational or experimental therapy will be given as part of this protocol.
* Audiograms will be performed at the Johns Hopkins Suburban Outpatient Center or the NIH Clinical Center.
* Two interim analyses will be conducted prior to study completion (after N=88 and N=176 subjects completing the protocol) to determine whether there are statistically significant differences in severity or incidence of hearing loss in subjects taking concurrent statin drugs vs. subjects who are not taking statin drugs.

Outcome Measures:

* Primary outcome measure: The primary outcome measure is the change in hearing sensitivity (as measured by the self-administered audiogram) between the pre-treatment (before cisplatin therapy) hearing test and the post-treatment (after completion of cisplatin therapy) audiogram. Hearing loss will be defined according to TUNE and ASHA criteria and will be compared in subjects taking statin drugs vs. subjects not taking statin drugs. Hearing status will be compared between audiograms collected at baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 4 weeks of cisplatin protocol cessation).
* Secondary outcome measure: Secondary outcome measures include 1) changes in hearing sensitivity between the first post-cisplatin audiogram and the second post-cisplatin audiogram, and 2) changes in scores on the tinnitus questionnaire between the pre-treatment audiogram and the two post-treatment audiograms.

Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation

Observational Study of Hearing Loss and the Effects of Statin Drugs in Head and Neck Squamous Cell Carcinoma Patients Treated With Cisplatin Chemoradiation

The primary outcome measure is the change in hearing sensitivity (as measured by the self-administered audiogram) between the pre-treatment (before cisplatin therapy) hearing test and the post-treatment (after completion of cisplatin therapy) audiogram. Hearing loss will be defined according to TUNE and ASHA criteria and will be compared in subjects taking statin drugs vs. subjects not taking statin drugs. Hearing status will be compared between audiograms collected at baseline (prior to treatment) to a repeated audiogram at the end of treatment (within 4 weeks of cisplatin protocol cessation).

Secondary outcome measures include 1) changes in hearing sensitivity between the first post-cisplatin audiogram and the second post-cisplatin audiogram, and 2) changes in scores on the tinnitus questionnaire between the pre-treatment audiogram and the two post-treatment audiograms.

National Institute on Deafness and Other Communication Disorders (NIDCD)

Gland and Hormone Related Diseases

Rare Diseases

Insulin Resistance

Hyperprolactinemia

Prolactinoma

Hyperinsulinism

Glucose Metabolism Disorders

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Endocrine Gland Neoplasms

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Galactorrhoea-Hyperprolactinaemia

Hypoglycemic Agents

Cardiotonic Agents

Insulin

Insulin, Globin Zinc

Dopamine

Dopamine Agonists

Erika CO Naliato, MSc

Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.

The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.

Insulin Resistance in Women With Prolactinoma

Insulin Resistance and Lipid Profile in Non-Obese Women With Prolactinoma Treated With Dopamine Agonists

Universidade Federal do Rio de Janeiro

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Digestive System Diseases

Heart and Blood Diseases

Immune System Diseases

Skin and Connective Tissue Diseases

Infections

Diabetes Mellitus

Anxiety Disorders

Depressive Disorder

Dementia

Kidney Diseases

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Osteoporosis

Thyroid Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Depression

Heart Failure

Asthma

Stroke

Hypertension

Gastroesophageal Reflux

Ischemia

Arthritis

Irritable Bowel Syndrome

Lung Diseases

Arthritis, Rheumatoid

Hepatitis A

Hepatitis

Acquired Immunodeficiency Syndrome

HIV Infections

Pain

Hepatitis, Chronic

Musculoskeletal Pain

Bronchitis

Ischemic Attack, Transient

Bronchitis, Chronic

Diverticulum

Diverticular Diseases

Vascular Diseases

Gastrointestinal Diseases

Joint Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Bone Diseases

Bone Diseases, Metabolic

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Muscular Diseases

Communicable Diseases

Respiratory Tract Infections

Bronchial Diseases

Brain Ischemia

Cerebrovascular Disorders

Pathological Conditions, Anatomical

Familial Alzheimer Disease

Chronic Graft Versus Host Disease

Intervention group (n = 163) Intervention: Participates in DIMAC02 Program

Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups(FMG) related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration. DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication. 2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.

DIMAC02

Martin Fortin, MD, M.Sc

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

A recent systematic review on the prevalence of Multimorbidity (MM) recommended a count of 3+ chronic diseases, with no focus on any single chronic disease in particular. This definition identifies a more vulnerable population with higher needs, lower income or poverty, poorer outcomes and challenging processes of care. It includes people with a wide array of complexity from the uncomplicated course of minimally interacting chronic diseases to the highly complex MM patients. MM is not only important due to the burden on patients, but because it accounts for high utilization. The definition represents a continuum of vulnerability in which there are many opportunities for prevention and management. Despite the high prevalence of MM, most research and health care is still based on a single disease paradigm which may not be appropriate as 45% of primary care patients have MM. A recent Cochrane systematic review on the impact of interventions for patients with MM has identified a paucity of studies internationally with mixed results, thus paving the way for the work of this Team. The most promising intervention, to date, was enhanced teamwork in a multifaceted intervention involving multiple professionals.

Patient-Centred Partnerships between Patients and Providers: The definition of patient-centred partnerships is derived from Canadian policy reports: "collaboration between informed, respected patients and a healthcare team." There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program: first, exploring the patients' diseases and the illness experience; second, understanding the whole person in context; third, finding common ground; and fourth, enhancing the patient-provider relationship. There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs. Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients.

Canadian policy reports defined this second facet of patient-centredness, as "seamless coordination and integration of care." Transitions requiring coordination are a key feature of care for patients with MM. Coordination has been shown to positively impact: symptom relief; social functioning; hospital re-admission and related costs. Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design.

STUDY #2.1 Qualitative Evaluation of the aligned Programs Purpose: The study will: assess how the transformed program performs; distinguish between components of the interventions; and identify contextual factors that may have influenced the content and effectiveness of the intervention. It will also examine the local barriers and facilitators as well as the transitions and coordination of care.

Methods and design: The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects \[1\] including the context of the health care systems in each province. A recent example of this research approach in Canada is Best et al, 2012 \[2\]. Data will be obtained from interviews and written documents. In-depth interviews will be conducted among the four categories of stakeholders. This will include: a) decision-makers (n = 10); b) primary care physicians (n = 10); c) professionals doing the interventions (n = 10); and a d) purposive sample of patients with multimorbidity (n = 10) and their informal caregivers (n=10) \[51\]. The number of interviews are estimates and will be guided by the saturation of data \[3\].

Data collection: In-depth interviews, lasting 30 to 60 minutes will ensure complete and detailed participation. The data collection will be held during the second year of the transformed program. The interview guides will examine how the context variables influence the effects and the elements that could potentially inform the development of future interventions. All interviews will be audiotaped and transcribed verbatim. Additionally, written documents will be collected (program team meeting summaries, a sample of 10 medical records or research records at each participating site, a checklist describing the fidelity of the intervention, all documents produced specifically for the intervention) to provide an in-depth understanding of the various contexts in which the interventions occurred.

Data analysis: The data will be analyzed using an iterative and interpretative approach \[4\]. The data from all participants will be examined through both independent and team analysis occurring in a concurrent manner to build and develop on the emerging themes. A coding template will be developed and edited as new themes emerge while others are reclassified or discarded. A data management software will be used to organize the coded data and identify exemplar quotes reflecting the central themes. All written documents will undergo a content analysis. The final step of the analysis will be the triangulation of the synthesis of the themes from the stakeholder participants and the content analysis of the documents.\[3-4\] STUDY #2.2: Evaluation of effects of the aligned Programs Setting: The same consenting participating sites as described in study 2.1. The methods presented below are for one setting and will be duplicated in the second setting. Patients are referred to receive the services of these programs by their providers. The intervention the investigators are testing here is the aligned programs. Patients referred to these programs are new patients and have never been exposed to the intervention. In addition to the main reason for referral to the program, the referral form will also include eligibility details for the evaluation, including diagnoses.

Patient sample: Patients recruited for the study will be cognitively intact and literate and aged between 18 and 80 years of age. The upper limit of 80 years is to avoid recruiting patients at risk of being institutionalized or dependent during the follow-up. Patients will present at least three chronic conditions.

Methods and Design: Patients agreeing to participate will complete questionnaires at baseline (T1) collecting the sociodemographic data and baseline measures, which will be used to document equivalence between groups (groups are defined below). Effectiveness of the aligned program will be assessed using three strategies.

1. To measure short-term effects (4 months), a randomized controlled trial (RCT) design with a delayed intervention will be used \[5\]. Eligible patients will be randomized after consent to receive either the intervention within a short period of time (Group A) or 4 months later (Group B); self-reported mailed questionnaires will be completed at baseline (T1) for all patient participants, 4 months after the end of the intervention for group A (T2) and 4 months after baseline for control group B (T2). This will constitute the short-term measure of effectiveness of the intervention. Group B will then receive the intervention.
2. To measure the mid-term effects (one year) on patient-reported outcomes, a before and after study is proposed combining groups A and B together. The patients will complete the same questionnaire 12 months after the end of the intervention (T3).
3. To measure mid-term (T3) and long-term effects (T4 after 2 years) on health services utilization and cost, all patients (groups A and B) will provide consent to give access to their health administrative (HA) data. At baseline, a control Group C will be constituted using anonymized HA data. Patients will be matched for gender, age, region and main three diagnoses. The Team will build algorithms for matching every set of controls. Groups A and B together will be compared to this propensity matched control group C in a before-after study using administrative (HA) data.

Variables and outcome measures: The variables fall into 5 categories: sociodemographic; PC context; main co-variables of interest; primary outcomes; secondary outcomes. Socio-demographic characteristics include gender, age, education, family income, marital status, occupation, housing and number of persons living under the same roof. Context variables refer to type of PC organization in which the intervention occurs (Family Medicine Group). The three main co-variables of interest are the Team's three innovations: self-reported multimorbidity (measured by the Disease Burden Morbidity Assessment \[6\]; patient-centred partnership (Patient Perception of Patient-Centredness Scale \[7-9\]); and Patient centered coordination (the Patient Perceptions of Transitions in care, adapted by the investigators from Coleman \[10\]). The two primary outcome measures are the Health Education Impact Questionnaire (HeiQ) that provides a broad profile of the potential impacts of patient education interventions \[11\] and the level of perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing Chronic Disease (SEM-CD) \[12\]. Secondary patient perceived outcomes will be the VR-12 as a measure of health status and the "EuroQoL group" instrument called "EQ5D" as a measure of Quality of Life \[13\]. The Kessler psychological distress scale K-6 will measure psychological distress \[14\]. The investigators will also use a questionnaire on health behaviors \[15\]. Finally, HA data will also be used as secondary outcomes to compare health care utilization and cost before and after the intervention. HA data will include emergency department visits, avoidable hospital admissions, readmissions, time to first primary care visit after emergency department visit and continuity of care.

Data analysis: Investigators will first describe participants' baseline characteristics in each group and compare among groups. To evaluate short-term effect, Groups A and B will be compared on T2 scores with an analysis of co-variance (ANCOVA) adjusted for T1 scores \[16\]. To document mid-term effects, a before and after measures analysis of variance will be used to study the evolution of continuous variables collected 3 times \[17\]. Sub-analyses by gender will be performed. Health system costs in intervention and control groups will be evaluated by using amounts paid to providers based on provincial fee schedules and cost-weighted utilization of institutions including hospitals and long-term care. Utilization records obtained from HA data will be multiplied by applicable cost weights \[18\] The methods employed will model the individual patient-level costs incurred in the health system, using methods developed for costing using administrative data\[19\]. Incremental resources in the intervention group will be identified and costed using applicable time/resource inputs and relevant wage rates following guidelines for economic evaluation in health interventions \[20\].

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement

Multimorbidity/Chronic Disease (MM-21): Score: number of Chronic diseases

Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Psychological Well-being (Kessler 6 Scale).Score: mean

Lifestyle/Health Behaviours Questionnaire. Score: mean

Patient Perception of Transitions of Care. Score: Mean

Self-Efficacy for Managing Chronic Disease Scale (SEM-CD). Score: mean

Patient Perception of Patient-Centredness (PPPC). Score: Mean

Canadian Institutes of Health Research (CIHR)

Western University, Canada

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

Université de Sherbrooke

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation	NCT03225157	Head and Neck N... Hearing Disorde... Hyperlipidemia		18 Years -	National Institutes of Health Clinical Center (CC)
Hearing Loss and the Effects of Statin Drugs in People With Head and Neck Squamous Cell Carcinoma Treated With Cisplatin Chemoradiation	NCT03225157	Head and Neck N... Hearing Disorde... Hyperlipidemia		18 Years -	National Institutes of Health Clinical Center (CC)
Insulin Resistance in Women With Prolactinoma	NCT00481299	Prolactinoma Insulin Resista... Hyperlipidemia		18 Years - 48 Years	Universidade Federal do Rio de Janeiro
Patient-Centred Innovations for Persons With Multimorbidity - Quebec	NCT02789800	Hypertension Depression Anxiety Musculoskeletal... Arthritis Rheumatoid Arth... Osteoporosis Chronic Obstruc... Asthma Chronic Bronchi... Cardiovascular ... Heart Failure Stroke Transient Ische... Ulcer Gastroesophagea... Irritable Bowel Crohn's Disease Ulcerative Coli... Diverticulosis Chronic Hepatit... Diabetes Thyroid Disorde... Cancer Kidney Disease Urinary Tract P... Dementia Alzheimer's Dis... Hyperlipidemia HIV	DIMAC02	18 Years - 80 Years	Université de Sherbrooke

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