Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Rare Diseases

Sclerosis

Tuberous Sclerosis

Behavioral Symptoms

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

In this 22-week almost completely remote study, following a 5-week control phase, parents will receive intensive treatment twice per week for 5 weeks followed by a one-time, 1-on-1 counseling session with an RT psychologist (week 11). Then, parents will use skill practice and application in the home environment for 10 weeks. Following this, a final interview is conducted (week 22).

In this 22-week almost completely remote study, following a 5-week control phase, children will receive intensive group treatment, twice a week for 5 weeks delivered remotely. During the children's sessions, they will use child structured videos, the PlayPosit curriculum and learning rewards. The following assessments will be completed by the parents, regarding their children, at each phase; EDI, ABC-2, FS, BRIEF-2, CRS, PSI-4SF and CGI-I. Following the completion of group treatment, there will be a one-time, 1-on-1 counseling session with an RT psychologist.

RT is small-group-based, intensive behavioral intervention session delivered twice weekly over a secure remote platform for 60-minutes over 5 weeks. Each session is led by a psychologist trained and certified in RT. Caregiver groups meet at the same frequency and duration but at different times. Each session has a specific focus for teaching participants to identify emotions and incorporation of cognitive behavioral therapy (CBT) and mindfulness skills that are reinforced through repeated practice. Each session will include a review, relaxation, new material didactic, activities to reinforce material, mindfulness, and homework.

Behavioral Intervention in a small group platform

Jamie Capal, MD

Jamie Capal

Darcy Krueger, MD

The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).

This is a non-pharmacological intervention that will utilize small group-based therapy with participants, followed by a separate caregiver session. The clinical trial will consist of four phases; 1) single in person screening/baseline visit; 2) RT control phase which is a 5-week observational period (Week 1-5); 3) RT intensive phase which is a remote group treatment intervention twice per week over 5 weeks (Week 6-10); 4) RT individualization phase, which is an individualized consultation with the participant and caregiver (Week 11); and 5) the RT generalization phase which is a 10 week follow up period consisting of utilizing the learned skills at home. At the end of the 10-week generalization phase, a semi-structured interview for thematic analysis will occur at the end of the study to capture facilitators and barriers to the intervention (Week 12-22).

Regulating Together in Tuberous Sclerosis Complex

Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Prevalence of emotion dysregulation is highly prevalent in TSC patients who exhibit problematic behaviors. The EDI-R score at the screening study visit will determine the EDI-R and determine the presence or absence of emotion dysregulation in the cohort.

EDI-R score will be compared from pre-treatment (control phase) to post-treatment (RT Intensive Phase and RT Generalization Phases combined). EDI-R is a caregiver administered, emotion dysregulation inventory with construct, range, and directionality that includes questions that the rater is asked to answer based on behaviors that are observed to cause problems. These questions include, but are not limited to, creating a dangerous situation, interference with daily activities, increasing the stress of those around the individual, and hurting relationships. There are 13 questions on the EDI-R; they are rated at, not at all, mild, moderate, severe, and very severe.

The primary endpoint will be CP-CTI responses from caregivers upon completion of RT Generalization Phase using a thematic analysis. This will identify obstacles to treatment access. Scores will be compared pre-treatment to post-treatment. CP-CTI is a staff administered, caregiver perspective clinical trial interview. This will occur through a telephone call from the study team to the caregiver.

United States Department of Defense

University of North Carolina, Chapel Hill

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Mouth and Tooth Diseases

Depression

Breast Neoplasms

Colorectal Neoplasms

Prostatic Neoplasms

Depressive Disorder

Leukemia

Melanoma

Mouth Neoplasms

Neurobehavioral Manifestations

Skin Diseases

Breast Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Standard care. Standard supportive care and Toolkit given at 12 weeks.

Interactive Voice Response (IVR) Reminders Daily delivery for the last 4 weeks of the study.

Interactive Voice Response (IVR) Reminders daily for the first 8 weeks of the study.

Interactive Voice Response (IVR) Reminders daily for the first 4 weeks of the study and every other day for weeks 4-8.

Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.

Interactive Voice Response (IVR) Reminders

Barbara Given, PhD

Charles Given, PhD

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR The goals of this study are to improve adherence to oral chemotherapeutic medications and self-management of symptoms among cancer patients. More than 40 oral agents currently are on the market with projections that in three years 30% of the cancer treatment agents will be delivered in oral form. As a result, patients must assume responsibility for taking medications and self-management of associated side effects.

This longitudinal randomized trial tests and compares 'two strategies' for improving patient adherence to their oral cancer medication prescriptions to standard care. Both strategies incorporate symptom management support using an interactive voice response system (IVR) for symptom assessment and a printed evidence-based Medication Management and Symptom Management Toolkit (Toolkit) with helpful strategies and information for symptom management.

We will collaborate with NCI Comprehensive Cancer Centers to recruit patients into this study. Recruiters will identify patients as they are prescribed oral cancer medications, present the study to the patient, and ask them to consent to be part of the study.

Study Aims Following are the Aims of the study.

1. Cancer patients assigned to the intervention will have greater adherence to their prescribed regimen: a) at week 4 (immediate effect), and b) at weeks 8 and 12 (sustained effect).
2. When compared with patients receiving weekly assessments only, patients receiving weekly assessments plus daily adherence reminders and printed symptom management strategies for 4 weeks will report: lower symptom severity during weeks 2-4 that will be sustained at weeks 5-8, and at 12 weeks.

Two exploratory aims are assessed:

1. To test how patient characteristics (age, sex, depression), dose variation, symptom severity, and concurrent infusion therapy moderate the impact of the novel intervention on adherence at 4, 8, and 12 weeks.
2. To test the impact of the novel intervention on dose alterations, emergency department visits and hospital admissions over the 12 weeks in order to support the translation of this system into oncology practices.

Design and Methods A unique feature of this study is that assessments, reminders, and symptom management strategies will be delivered by an Interactive Voice Response system (IVR). This system has been tested in a previous trial and in a pilot study of medication adherence; it received high satisfaction ratings from patients.

All patients will complete intake (baseline), 4 week, 8 week, and 12 week interviews for symptom severity, depression, beliefs about oral agents, self-efficacy, and pill count. Following the intake interview a computerized procedure will randomize patients to one of two groups: experimental and control. Patients in both arms will receive 12 weekly assessments of adherence to their oral cancer medications and symptom severity delivered by the IVR.

In addition, patients in the experimental group will receive daily reminder calls for 4 weeks delivered by the IVR. At the end of week 4 patients will be offered the option to reduce calls to every other day, or continue with daily reminders for weeks 5-8. Reminder calls will be tailored to the cycle of each medication. Daily reminder calls include a question to determine if medication changes have occurred. If this occurs, reminder calls are stopped and/or adjusted to the revised prescription. Patients in the experimental group will be mailed a Toolkit. Patients who report symptoms above designated thresholds during a weekly assessment call will be referred to the Toolkit to assist with self-management.

The control group will not receive IVR reminder calls during the first 8 weeks. Control group patients, who report difficulty taking their cancer medications as prescribed, will be randomized following the 8 week interview to either receive 4 weeks of daily IVR reminder calls during weeks 9-12, or to continue in the control group. Patients randomized to receive daily IVR reminder calls will receive a Toolkit following randomization (and if during their weekly assessment calls they report symptoms above designated thresholds they will be referred to the Toolkit to assist with self-management). Patients randomized to continue in the control group will receive a Toolkit upon completion of the 12 week interview.

Medical records will be audited for oral cancer medication changes during the study period as well as adverse toxic events noted, and scripts written.

Implications \& Impact This research will identify and explore the factors (symptom severity, medication complexity, patient characteristics) affecting adherence to oral cancer medications and how symptom management might improve levels of adherence. This will allow patients to engage in their care and potentially transform the safety and quality of cancer care for patients on oral cancer medications.

Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR

Individual participant data will not be made available.

this assesses the ability to believe that they can adhere

The Given Symptom assessment tool is used

This is an adaptation of the Cleeland Interference scale

We use the PROMIS physical function measure

This captures the use during the 8 weeks and is Emergency room use and hospital admissions including length of stay.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Regulating Together in Tuberous Sclerosis Complex	NCT06105736	TSC Behavioral Symp...	Behavioral Inte...	8 Years - 17 Years	University of North Carolina, Chapel Hill
Regulating Together in Tuberous Sclerosis Complex	NCT06105736	TSC Behavioral Symp...	Behavioral Inte...	8 Years - 17 Years	University of North Carolina, Chapel Hill
Improving Adherence to Oral Cancer Agents and Self Care of Symptoms Using an IVR	NCT02043184	Prostatic Neopl... Breast Neoplasm... Colorectal Neop... Melanoma Leukemia	Interactive Voi...	21 Years -	Michigan State University

Spots Global Cancer Trial Database for behavioral symptoms