Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Immune System Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Diabetes Mellitus

Kidney Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Anemia, Sickle Cell

Diabetes Mellitus, Type 1

Fibrosis

Lupus Erythematosus, Systemic

Cystic Fibrosis

Renal Insufficiency, Chronic

Renal Insufficiency

Anemia

Chronic Disease

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Disease Attributes

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Gastroenteritis

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hematologic Diseases

Hemoglobinopathies

Connective Tissue Diseases

Autoimmune Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Sickle Cell Anemia

Chronic Graft Versus Host Disease

Peer coaching intervention delivered by young adults with a childhood onset chronic condition and trained in coaching curriculum that includes motivational interviewing techniques and the benefits of peer relationships over a shared experience such as a chronic condition. The peer coach supports the AYA to identify their goals and feel a sense of success in making change towards goals within a supportive environment. This process involves goal-setting, development of self-discovery and accountability for changes in health behavior. The peer coach elicits the AYA's vision of optimal health and identifies the AYAs values. As the AYAs identify a vision of wellness and develop goals and action steps to progress towards that vision, the peer coach elicits the AYA's intrinsic motivation and activates skill development in self-advocacy and communication and empowers the AYA to take leadership in managing their condition.

Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.

This mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach who has already developed independence an active self-manager. Peers with shared experiences provide instrumental (e.g., health maintenance skills) and emotional support that likely lead to improvements in quality of life. Involving peers in supporting AYAs with chronic conditions to promote self-management and patient activation disrupts the typical over-reliance on the parent and health care provider that often impedes developing independence.

PiCASO Intervention Group

Sham Comparator: Attention Control Group

Angel Barnes, BSN

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

Increases in life expectancy in almost all childhood-onset chronic conditions (COCC) has brought unique challenges for adolescents and young adults (AYA) who struggle to deal with the associated disease burden, manage therapies, and thrive as they develop independent self-management skills, and become active and engaged patients. The challenges that influence the lives of AYAs are largely adaptive, such as making lifestyle modifications, adhering to complex medication regimens, and learning to navigate the adult health system. Adding to this complexity is the need for AYAs to progressively take over greater self-management responsibilities from parents. Promoting activated self-management is critically important given that this shift in health care management from parents and health care providers to the AYA is identified as key to successful adult outcomes. Peer support interventions are well-suited to address challenges theorized as critical to AYAs given the importance of peer relationships during this time. The investigators propose a mixed-methods, five-year randomized controlled trial, that will include 225 AYAs (16-22 years) with COCCs, to test the Peer i-Coaching for Activated Self-Management Optimization (PICASO) versus an attention control group. This novel, mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach (18-26 years), who has already developed independence and is an active self-manager. The investigators will determine the efficacy of PICASO on self-management, patient activation, transition readiness, health-related quality, and emotional health of life across 12 months. The investigators will explore whether age, sex, race/ethnicity, chronic condition, and/or disease severity moderate the trajectory of PICASO effects on self-management, patient activation, coping, emotional health and health-related quality of life. Lastly, the investigators will explore mechanisms of the PICASO impact by describing AYA experiences with the intervention.

Five year randomized controlled trial to test efficacy of behavioral intervention versus attention control group on primary and secondary outcomes across 12 months.

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

Peer i-Coaching for Activated Self-management Optimization in Adolescents and Young Adults With Chronic Conditions

Self-management variable measured using the Partners in Health Scale (PIH): measures chronic illness self-management by assessing chronic condition self-management knowledge, partnership in treatment, recognition and management of symptoms, and coping. This 12 item self-report scale is scored on a 9-point Likert scale (range: 0-8; higher scores indicate better self-management), providing total and subscale scores (knowledge, coping, recognition and management of functions, adherence to treatment).

Patient Activation variable measured using the Patient Activation Measure (PAM-13): measures patient activation through self-reports of knowledge, skills, and confidence related to self-management of one's own health care. This 13-item self-report assesses confidence in self-management and understanding of health condition and is scored on a 5-point Likert scale (range: 0-100 with higher scores indicating higher patient activation in self-management).

Transition readiness variable measured using Transition Readiness Assessment Questionnaire (TRAQ 20): 20-item self-report assessment of the ability to make appointments, manage medications, track health issues, talk with providers, and manage daily activities. The TRAQ scores produced include an overall score and a subscale score for each of the five subscales. The overall score and the subscale scores are calculated by taking the average score across the items in the questionnaire (or subscale). Each item is scored 1-5. Higher scores indicate more transition readiness

Health-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses physical and mental health related quality of life. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100 and were designed to have a mean score of 50. Higher scores indicate better physical functioning.

Emotional health variable measured using the Brief Symptom Inventory: 18-item self-report of emotional symptoms experienced over the previous 7 days. Subscales include depression, anxiety, and somatization. 5-point Likert scale, with three sub-scale scores and an overall global psychological distress score. Higher scores indicate more psychological distress.

National Institutes of Health (NIH)

National Institute of Nursing Research (NINR)

Duke University

Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Keratosis, Actinic

Keratosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Precancerous Conditions

Neoplasms, Squamous Cell

Dermatologic Agents

All Drugs and Chemicals

Afamelanotide

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months

Placebo implant administered subcutaneously every 60 days for 24 months

16 mg subcutaneous implant administered every 60 days

Afamelanotide (CUV1647)

Placebo subcutaneous implant administered every 60 days

Placebo

Günther Hofbauer, M.D.

The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

Phase II AK Study in Organ Transplant Patients

A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.

Clinuvel Pharmaceuticals Limited

Dr Dennis Wright

Asthma

Metabolism, Inborn Errors

Participants will be receiving their standard medical care.

Participants will be receiving the intervention on top of their standard medical care.

A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants in the intervention arm to use during their telemedicine consultations with health care providers.

A sphygmanometer, a digital thermometer, a pulse oximeter and a peak flow meter will be given to participants to use during their telemedicine consultations with health care providers.

Maria Ntessalen

Peter Murchie

This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.

ORCHARD- Optimising Home Assessment of Rural Patients

Optimising Remote Consulting and Home Assessment of Medically Vulnerable Rural Patients During Unscheduled and Planned Primary Care- Assessing Feasibility of the ORCHARD Intervention

The questionnaire will assess use of equipment, perception of how helpful the equipment was for the consultation and the reasons why it was helpful.

Qualitative data collected at the end of the study according to a topic guide.

Number of Scottish ambulance service call-outs

Number of face-to-face paramedic assessment

University of Aberdeen

Lymphoma

Lymphosarcoma

Immunosuppressive Agents

Michel MARTY, MD

About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

* Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
* Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
* Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

* Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
* Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
* Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
* Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

This is an observational and comparative study (2 control patients are recruited for each 1 case patient).

A case patient is a patient who has developed a cancer after his/her transplant.

A control patient is a patient who has not developed a cancer after his/her transplant.

These 2 groups will be matched according to specific inclusion criteria.

Study of Cancers After Solid Organs Transplants

Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

CANCEROPOLE Ile-de-France

Assistance Publique - Hôpitaux de Paris

Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.

Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.

Educational Intervention

Dennis P West, PhD

June K Robinson, MD

Using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (SSE). The investigators hypothesis is if the patient learns by acquiring skills in a favorable environment, then the patient may reduce their anxiety, enhance self-efficacy and perform self-management by SSE and sun protection. The investigators also evaluate existing internet sources of primary and secondary prevention of skin cancer for organ transplant recipients.

Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients

The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.

Northwestern University

Professor of Dermatology

Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.

Control

Intervention

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

* Small sample at a single center for a limited period of follow-up
* The dermatologists' assessment of the participants' concerning lesions was not performed

June Robinson, MD

Educational intervention consisting of a mnemonic and a workboook

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions	NCT03938324	Sickle Cell Dis... Chronic Kidney ... Systemic Lupus ... Childhood Cance... Inflammatory Bo... Stem Cell Trans... Organ Transplan... Diabetes Mellit... Cystic Fibrosis	PiCASO Interven... Sham Comparator...	16 Years - 22 Years	Duke University
Phase II AK Study in Organ Transplant Patients	NCT00829192	Actinic Keratos... Carcinoma, Squa... Organ Transplan...	Afamelanotide (... Placebo	18 Years - 75 Years	Clinuvel Pharmaceuticals Limited
ORCHARD- Optimising Home Assessment of Rural Patients	NCT05732922	Organ Transplan... Cancer Inborn Errors o... Immunosuppressi... COPD Asthma Sickle Cell Dis...	A sphygmanomete...	18 Years - 100 Years	University of Aberdeen
Study of Cancers After Solid Organs Transplants	NCT00948883	Cancer Organ Transplan...		18 Years -	Assistance Publique - Hôpitaux de Paris
ORCHARD- Optimising Home Assessment of Rural Patients	NCT05732922	Organ Transplan... Cancer Inborn Errors o... Immunosuppressi... COPD Asthma Sickle Cell Dis...	A sphygmanomete...	18 Years - 100 Years	University of Aberdeen
Study of Cancers After Solid Organs Transplants	NCT00948883	Cancer Organ Transplan...		18 Years -	Assistance Publique - Hôpitaux de Paris
ORCHARD- Optimising Home Assessment of Rural Patients	NCT05732922	Organ Transplan... Cancer Inborn Errors o... Immunosuppressi... COPD Asthma Sickle Cell Dis...	A sphygmanomete...	18 Years - 100 Years	University of Aberdeen
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients	NCT01127737	Squamous Cell C...	Educational Int... Placebo	18 Years - 85 Years	Northwestern University

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