Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Quality of Life

Neurofibromatosis

Neurofibromatosis Type 1

Barbara B Biesecker

This study aims to understand predictors of adaptation and quality of life among adults affected with neurofibromatosis type 1 (NF1) and autosomal dominant neurocutaneous condition. NF1 carries a significant psychosocial burden for affected individuals. Aspects of NF1 that are especially challenging include the unpredictable nature of the disease, variability in severity of symptoms and medical complications, uncertainty in progression, and vulnerability to stigmatization due to the highly visible and often cosmetically disfiguring features of the condition. The literature suggests that because of these and other challenges posed by NF1, affected individuals may struggle to adapt to their condition and, consequently, experience poor quality of life. In this study, Lazarus and Folkman s Tranactional Model of Stress and Coping is used as a framework to conceptualize adaptation and quality of life to NF1. A cross-sectional design with quantitative methodology will be employed to investigate the relationships of appraisals and stigma as predictors of adaptation and quality of life. Adults affected with NF1 will be recruited via regional and national NF organizations and websites, as well as through ongoing NIH clinical research protocols for NF1. Eligible participants will be invited to complete a web-based, self-administered survey....

This study aims to understand predictors of adaptation and quality of life among adults affected with neurofibromatosis type 1 (NF1) and autosomal dominant neurocutaneous condition. NF1 carries a significant psychosocial burden for affected individuals. Aspects of NF1 that are especially challenging include the unpredictable nature of the disease, variability in severity of symptoms and medical complications, uncertainty in progression, and vulnerability to stigmatization due to the highly visible and often cosmetically disfiguring features of the condition. The literature suggests that because of these and other challenges posed by NF1, affected individuals may struggle to adapt to their condition and, consequently, experience poor quality of life. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping is used as a framework to conceptualize adaptation and quality of life to NF1. A cross-sectional design with quantitative methodology will be employed to investigate the relationships of appraisals and stigma as predictors of adaptation and quality of life. Adults affected with NF1 will be recruited via regional and national NF organizations and websites, as well as through ongoing NIH clinical research protocols for NF1. Eligible participants will be invited to complete a web-based, self-administered survey.

Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I

National Human Genome Research Institute (NHGRI)

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Group-based psychosocial intervention adapted from Mindful Self-Compassion that focuses on the development of mindfulness and self-compassion skills to reduce lung cancer stigma.

Control group that will receive a list of mental health resources and will complete questionnaire assessments during a parallel timeframe as participants in the intervention condition and be placed on a waiting list to receive the MSC-LC intervention after study completion.

The overall goal of this 10-week, group-based, virtually-delivered, psychosocial intervention is to enhance recognition and responsiveness to difficult thoughts and emotions and to build self-compassion skills that facilitate patients' ability to turn inward to those thoughts and feelings with mindfulness, connectedness, and self-kindness. Each weekly session is designed to be 90 minutes and follows an agenda with highly structured scripts covering self-compassion topics (e.g., pain of disconnection, listening with compassion), which are carefully organized to build upon one another. In each session, didactic topics (e.g., "What is self-compassion?") taught by trained interventionists lead into guided experiential learning practices (e.g., guided meditation), which are then followed by inquiry into the participants' direct experiences of the practices. The treatment manual is adapted based on the Mindful Self-Compassion Teacher Guide (from the Center for Mindful Self-Compassion).

Mindful Self-Compassion for Lung Cancer (MSC-LC)

Participants in the enhanced standard of care control condition will be provided with an information sheet from the NCI about how to find helpful organizations and resources in their community. Self-report will be used to describe any supportive care services pursued by the participant. Additionally, control participants will be added to a waiting list for receiving the MSC-LC intervention program. After completing all questionnaire assessments (16 weeks following study entry), the study team will offer the MSC-LC intervention program to participants on the waiting list.

Enhanced standard of care with waitlist

Timothy J Williamson, Ph.D., MPH

The goal of this pilot clinical trial is to test a disease-tailored, mindfulness-based intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) in adults diagnosed with lung cancer who are experiencing stigma. The current project seeks to:

* Evaluate preliminary evidence for the feasibility, acceptability, and preliminary efficacy of MSC-LC in reducing stigma for adults with lung cancer, compared to a waitlist control condition
* Elicit interventional impact not captured through quantitative measures with qualitative data from purposively sampled high responders and non-responders from the intervention condition

Participants will randomized to either the MSC-LC intervention (a 10-week, virtually-delivered, group-based psychosocial intervention focused on the development of mindfulness and self-compassion skills) or to a waitlist control group that receives a referral to an NCI list of helpful mental health resources in their community. Researchers will compare the intervention and control groups to see if the MSC-LC intervention reduces lung cancer stigma and increases self-compassion.

Lung cancer stigma (i.e., perceived and internalized negative appraisal and devaluation associated with lung cancer) is a pervasive problem experienced by the majority of lung cancer patients. Notably, experiences of lung cancer stigma are strongly associated with poorer quality of life and higher depressive symptoms. Despite these associations, there is a gap in the field regarding empirically supported, patient-focused interventions that target the reduction of lung cancer stigma.

Self-compassion (i.e., directed kindness towards oneself in times of suffering) is a protective psychosocial factor that has been targeted through intervention approaches to reduce shame and self-criticism in non-cancer samples. Additionally, higher self-compassion has been shown to attenuate the relationship between lung cancer stigma and depression, suggesting that fostering self-compassion may be an effective intervention strategy to reduce lung cancer stigma. Mindful Self-Compassion is an empirically supported, 8-week psychosocial intervention demonstrated to increase self-compassion and reduce feelings of shame, distress, depression, and anxiety in non-cancer samples. However, given several anticipated challenges associated with delivering Mindful Self-Compassion to lung cancer patients (e.g., breathing challenges that arise during breath-focused meditations, fatigue that interferes with attending 3-hour sessions), the investigators developed an adapted version of the intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) that is tailored to the needs of adults diagnosed with lung cancer, addresses delivery challenges, and targets the reduction of lung cancer stigma.

This is a pilot trial examining the feasibility, acceptability, and preliminary efficacy of MSC-LC, compared to waitlist control condition. The central hypothesis is that MSC-LC will be demonstrate high feasibility and acceptability as well as preliminary efficacy in reducing lung cancer stigma and promoting self-compassion.

Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma

Loyola Marymount University supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.

This measure will be calculated as a count of sessions that each consented participant in the MSC-LC intervention attended. It will be used as a metric of acceptability of the intervention.

This measure will be calculated as a proportion of the number of components within an intervention session that the interventionists delivered (assessed via audio recording) over the number of pre-determined components that they were meant to deliver, per the interventionist manual.

The Lung Cancer Stigma Inventory is a self-report questionnaire of lung cancer stigma, which includes 25 items rated on a 5-point Likert scale. Scores range from 25-125, with higher scores indicating higher lung cancer stigma.

The Patient Health Questionnaire-8 is a self-report questionnaire of depressive symptoms, which includes 8 items rated on a 4-point Likert scale. Scores range from 0-24, with higher scores indicating higher depressive symptoms.

The Generalized Anxiety Disorder-7 is a self-report questionnaire of anxiety symptoms, which includes 7 items rated on a 4-point Likert scale. Scores range from 0-21, with higher scores indicating higher anxiety symptoms.

The Self-Compassion Scale is a self-report questionnaire of self-compassion, which includes 26 items rated on a 5-point Likert scale. Scores range from 26-130, with higher scores indicating higher self-compassion.

The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being is a self-report questionnaire on meaning and peace, which includes 8 items rated on a 5-point Likert scale. Scores range from 0-48, with higher scores indicating higher self-reported meaning and peace during chronic illness.

National Cancer Institute (NCI)

Loyola Marymount University

Assistant Professor

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Childhood Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Counselling interviews and workshops will be held simultaneously with the children receiving the web-based training. There are 4 modules in total. The first module lasts 2 weeks. The counselling interview will start in the 2nd week. Implementation will be completed in 5 weeks.

It includes 4 modules that develop children's communication, coping and social life skills and psychosocial preparation for the return to school process. The modules include theoretical explanations, stories, workshops and counselling sessions.

training and counselling

Gizem Cakir, PhD(c)

This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer.

H1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme?

Importance of research There are disease-specific medical and psychosocial difficulties that children with a diagnosis of cancer may experience. Standard school nursing practices can be helpful in meeting the physical, emotional, psychological, social and academic needs of children. However, a standard of care that is decided to be applied on return to school has not been developed. Therefore, it is thought that standard school nursing practices are not sufficient to meet the health and educational needs of children with cancer diagnosis. In the world, plans have been made using practices/methods/models appropriate for the population in the school return process of children followed up with a diagnosis of cancer. It is recommended to develop back-to-school programmes as they can benefit the child, family, peers, teachers and school staff who are followed up with a diagnosis of cancer. In our study, we aim to manage the transition care schematically with the back-to-school protocol to be made between the school-family-hospital, and to ensure care coordination and the safety of the child. The fact that the intervention in the back-to-school adaptation programme will be made to the child, parents, teachers and peers shows a holistic approach to the needs.

Place of application:

It will be performed in the paediatric leukaemia outpatient clinic of the Children's Hospital.

Study Population The population of the study consisted of children who were followed up in the paediatric leukaemia outpatient clinic of the Children's Hospital with a diagnosis of cancer.

Sample of the study The research will be conducted with a single group. In a publication on programme evaluation studies, it is recommended that the eta square should be at least 0.06 and 85% power. Based on this information, the sample size estimated by G\*Power analysis with 85% power and 5% margin of error is 26. Although there is no similar study in the literature in terms of method and measurement tools, it is seen that case loss is between 16-32% in studies conducted with similar populations within the scope of back-to-school intervention. For this reason, the calculated sample size was increased by 32% and the sample size was determined as 35.

Data Collection Tools The following forms were planned to be used in data collection.

1. Child and Parent Descriptive Information Form
2. Data Collection Form for Children's Return to School Process
3. Social Anxiety Scale for Children-Revised Version
4. Social Anxiety Scale for Adolescents
5. Paediatric Cancer Coping Scale
6. Readiness to Return to School Scale for Children with Oncological Problems: 7-18 Age
7. Process Evaluation Forms

Statistical analysis The data obtained from the research will be evaluated in SPSS 29.0 package data programme. In the analysis of the data, independent groups t-test will be applied for sociodemographic data with normal distribution. In the comparison of the measurements before and after the implementation of the back-to-school adaptation programme to the group, t-test will be used for parametric assumptions, and Wilcoxon signed-rank test will be used when parametric assumptions cannot be met. In order to measure the statistical significance of dependent groups, one-factor analysis of variance will be used if parametric assumptions are met, Friedman analysis of variance will be used if parametric assumptions are not met. The significance level for descriptive statistics is p\<0.05. Thematic content analysis method will be used in the evaluation of qualitative data.

The research is a technical/scientific/collaborative action research design.

Return to School Adaptation Programme for Children With Cancer

Efficacy of the Web-based Return to School Adaptation Programme for Children With Cancer: a Meta-theory-based Action Research

individual participant data will not be shared with other researchers. Since the data is individual, it is not ethically appropriate.

Social anxiety scale fo children-revised. Scores that can be obtained from the scale are between 18-90 and as the scale score increases, the level of social anxiety increases.

Paediatric Cancer Coping Scale. Scores that can be obtained from the scale are between 0-99 and coping strategies increase as the scale score increases.

Back to school readiness scale for children with oncological problems: 7-18 years of age. The score that can be obtained from the scale is between 0 and 152 and a higher score indicates an increase in school readiness.

Return to School Process Data Collection Form

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I	NCT00684398	Neurofibromatos... Von Recklinghau... NF1		18 Years -	National Institutes of Health Clinical Center (CC)
Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma	NCT06191939	Lung Cancer	Mindful Self-Co... Enhanced standa...	18 Years - 100 Years	Loyola Marymount University
Return to School Adaptation Programme for Children With Cancer	NCT06389357	Childhood Cance... ALL, Childhood AML, Childhood Lymphoma Solid Tumor, Ch...	training and co...	8 Years - 17 Years	Gazi University
Return to School Adaptation Programme for Children With Cancer	NCT06389357	Childhood Cance... ALL, Childhood AML, Childhood Lymphoma Solid Tumor, Ch...	training and co...	8 Years - 17 Years	Gazi University
Adaptation and Quality of Life Among Adults With Neurofibromatosis Type I	NCT00684398	Neurofibromatos... Von Recklinghau... NF1		18 Years -	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for adaptation

Every month we try and update this database with for adaptation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adaptation

Every month we try and update this database with for adaptation cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adaptation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.