Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants in this Arm will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Participants in this Arm will receive the ESSI-SURG behavioural intervention by a live SLP.

Patients will receive 3 face-to-face sessions with a speech-language pathologist (SLP), each with a specific goal, namely: pre-surgical educational, a post-operative day 3 therapy, and post-operative day 7 therapy. Following discharge from hospital, participants will be seen by an SLP for 4 weekly sessions, offered via telehealth or face-to-face depending on the patient's clinic schedule and/or availability.

ESSI-SURG

Participants will receive the current standard of care, which includes a referral to SLP in response to suspicion of a swallowing problem from either assessment by the medical team and/or patient report.

Standard-of-Care

Trixie Reichardt, MHSc

Rosemary Martino, PhD

Jonathan Irish, MD

Oral cavity cancer (OCC) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. Patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. Not only is dysphagia an independent predictor of quality of life (QoL) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. Emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (SLPs) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. This in turn has the potential to reduce complications and minimize the length of feeding tube dependency.

This study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic SLP speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. We will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.

Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically

Feasibility success will be defined as the following across all patients and compared by arm: an accrual rate \>90%.

Feasibility success will be defined as the following across all patients and compared by arm: an attrition rate of \<10%.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>80% for clinical assessments.

Feasibility success will be defined as the following across all patients and compared by arm: data fidelity rate of \>90% for patient reported outcomes.

University Health Network, Toronto

Principal Investigator

Symptoms and General Pathology

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Sclerosis

Rett Syndrome

Muscular Dystrophies

Prader-Willi Syndrome

Angelman Syndrome

Fragile X Syndrome

Muscular Dystrophy, Duchenne

Down Syndrome

Developmental Disabilities

Klinefelter Syndrome

Tuberous Sclerosis

Turner Syndrome

Gonadal Dysgenesis

Williams Syndrome

DiGeorge Syndrome

Smith-Magenis Syndrome

Atrophy

Muscular Diseases

Muscular Disorders, Atrophic

Neuromuscular Diseases

Genetic Diseases, Inborn

Genetic Diseases, X-Linked

Intellectual Disability

Neurobehavioral Manifestations

Neurologic Manifestations

Congenital Abnormalities

Abnormalities, Multiple

Chromosome Disorders

Obesity

Overweight

Overnutrition

Nutrition Disorders

Mental Retardation, X-Linked

Sex Chromosome Disorders

Heredodegenerative Disorders, Nervous System

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Neurodegenerative Diseases

Disorders of Sex Development

Urogenital Abnormalities

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Heart Defects, Congenital

Cardiovascular Abnormalities

Heart Diseases

Gonadal Disorders

Endocrine System Diseases

Movement Disorders

Central Nervous System Diseases

Hypogonadism

Constriction, Pathologic

Aortic Valve Stenosis

Aortic Stenosis, Supravalvular

Aortic Valve Disease

Heart Valve Diseases

22q11 Deletion Syndrome

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Lymphatic Abnormalities

Lymphatic Diseases

Hypoparathyroidism

Parathyroid Diseases

Chronobiology Disorders

Muscular Dystrophy

Becker Muscular Dystrophy

Duchenne Muscular Dystrophy

Tuberous Sclerosis Complex

22q13.3 Deletion Syndrome

22q11.2 Deletion Syndrome

Lymphatic Malformations

Psychoeducation around the diagnosed disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Parent-Infant Inter(X)action Intervention (PIXI)

Anne Wheeler, PhD

The objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. The proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays.

Participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) within the first year of life and their parents/caregivers.

The intervention, called the Parent and Infant Inter(X)action Intervention (PIXI) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. The protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

The primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile X, Angelman, Prader-Willi, Dup15q, Phelan-McDermid, Rhett, Smith Magenis, Williams, Turner, Kleinfelter, Down syndromes, Duchenne muscular dystrophy) identified prior to emergence of symptoms. PiXI aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders.

The investigators aim to 1) develop PIXI with a pilot sample of families, 2) test the preliminary effects of PIXI on infant and parent outcomes

The intervention, called Parent-infant Interaction Intervention (PIXI) is a comprehensive intervention provided across the first year of life for parents/caregivers of infants identified with a rare neurogenetic disorder. It includes psychoeducation around the disorder, early development, and service navigation along with parent-child interaction activities, parent coaching, and family/parent well-being support.

Parent and Infant Inter(X)Action Intervention (PIXI)

Piloting an Early Intervention Program for Infants With Rare Neurogenetic Disorders

A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention.

A social validity measure will be completed to better understand to inquire about family satisfaction with aspects of the intervention including curriculum, timing, goals targeted, and perceived effects of the intervention. Qualitative interviewing will be also be conducted to examine parent perceptions of feasibility and acceptability.

Overall intervention fidelity will be measured by determining if the following goals were achieved:

Enrollment target of 10-15 families 80% retention rate with at least 75% completing the 20 sessions across Phase 1 and Phase 2

Internal parent implementation and engagement forms will be used to measure parent participation across both intervention phases. These components include parent readiness for the session, attention to materials, participation in topic discussion, appropriateness of intervention activity practice, and general presentation with their child.

Descriptive statistics around early learning, motor, communication skills, interpersonal, and adaptive skills in the sample will be derived from the Vineland Adaptive Behavior Scales, Third Edition: Parent/Caregiver Report (Vineland-3). Subdomain v-Scaled scores range from 1-24 with higher numbers indicating greater performance; while domain scores are presented in standard score formats with a range of 20-140 with higher scores indicating greater performance.

A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Communication and Symbolic Behavior Scale (CSBS). The parent report developmental profile is a standardized measure is completed to evaluate language and social communication predictors. A total of 57 points are available with age corresponding cutoff scores for clinical concern.

A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Modified Checklist for Autism in Toddlers (MCHAT). The Modified Checklist for Autism in Toddlers is a scientifically validated tool for screening children between 16 and 30 months of age that assesses risk for autism spectrum disorder (ASD).Scores range from 0-20 with corresponding ranges for cutoff scores warranting further follow-up.

A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). The ADOS-2 is a semi-structured, standardized assessment of communication, social interaction, play, and restricted and repetitive behaviors. It is directly administered to the participant and behaviors are scored. Total scores range based on age of participant/module administered. Scores are calculated and compared against cutoff scores for autism spectrum and autism.

A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the TELE-ASD-PEDS. The TELE-ASD-PEDS was developed by researchers at Vanderbilt University to assess remotely autism symptomology. The TELE-ASD-PEDS measures communication, social interaction, play, and restricted and repetitive behaviors. It is administered via telehealth and behaviors are scored. Total scores range based on age of participant/module administered. Scores are calculated and compared against cutoff scores for autism spectrum and autism.

A combination of measures will be used across study engagement to assess parent reported autism symptomology. These measures include the Repetitive Behavior Scales (RBS). The RBS-EC is a questionnaire measure of restricted and repetitive behaviors designed for use in children from infancy through early school age. It is intended to capture individual differences across a broad range of behaviors associated with the repetitive behavior domain. Total scores range from 0-136 with a higher score indicating greater need/presence of behaviors.

University of North Carolina, Chapel Hill

RTI International

At the point of randomization the early group will receive increasingly intensive reminders to complete specific cancer screening tests.

Early Intervention

One year from the point of randomization patients will begin to receive increasingly intensive reminders to complete specific cancer screening tests.

Delayed intervention

Kevin Fiscella, MD, MPH

The purpose of this project is to improve cancer screening rates within practices serving low-income minority patients

This project is designed to implement and rigorously evaluate a cancer screening quality improvement project within a practice serving underserved patients. The project involves use of a patient registry coupled with patient reminders,recall and outreach.All unscreened patients will receive the benefit of this intervention, though some sooner than others for the purpose of evaluation.

Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities

American Cancer Society, Inc.

University of Rochester

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically	NCT06192771	Dysphagia Head and Neck C...	ESSI-SURG Standard-of-Car...	18 Years -	University Health Network, Toronto
Parent and Infant Inter(X)Action Intervention (PIXI)	NCT03836300	Fragile X Syndr... Angelman Syndro... Prader-Willi Sy... Dup15Q Syndrome Duchenne Muscul... Phelan-McDermid... Rett Syndrome Smith Magenis S... Williams Syndro... Turner Syndrome Klinefelter Syn... Chromosome 22q1... Tuberous Sclero... Down Syndrome	Parent-Infant I...	- 99 Years	RTI International
Primary Care Based Randomized Trial to Reduce Cancer Screening Disparities	NCT00818857	Preventive Meas...	Early Intervent... Delayed interve...	40 Years - 75 Years	University of Rochester
Feasibility of Early Swallowing and Speech Intervention for Head and Neck Cancer Patients Treated SURGically	NCT06192771	Dysphagia Head and Neck C...	ESSI-SURG Standard-of-Car...	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for early intervention