Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Children's Tumor Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this research is to adapt the NF-specific adult version of the Skype 3RP for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Management Group 1 | Experimental | Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
|
| Stress Management Group 2 | Experimental | Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management Group 1 | Behavioral | Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (WHO-QOLBREFadol) | Measures quality of life | Change between Baseline (week0), Post-intervention (Week8) and Follow Up (Week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) | Situations in one's life over the past month/week are appraised as stressful | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The Pain Catastrophizing Scale - Child Version (PCS-C) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Basic demographics | Baseline (week 0) |
| Expectancy Questionnaire | Measures how much the participant believes the intervention will work |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana-Maira Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stress Management Group 2 | Behavioral | Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques. |
|
Measures how individuals experience pain |
| Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Patient Health Questionnaire for Adolescents (PHQ-A) | Symptoms of depression and functional impairment | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Pain Interference Index (PII) | How much pain has interfered with their life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Child and Adolescent Mindfulness Measure (CAMM) | Assesses mindfulness in children and adolescents | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Interpersonal Reactivity Index (IRI) | Assesses the cognitive and affective dimensions of empathy | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Epworth Sleepiness Scale-Revised for Children (ESS) | Measures how likely one is to doze off or sleep in certain situations | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Gratitude Questionnaire Six-Item Form (GQ-6) | Assesses individual differences in the proneness to experience gratitude in daily life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Life Orientation Test (LOT) Optimism Scale | Individual differences in generalized optimism versus pessimism | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being Scale (FACIT-Sp) | Spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| MOS (Support/Empathy) | Measures recent thinking about the various dimensions of social support. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Measure of Current Status (MOCS) Part A | Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Generalized Anxiety Disorder 7-item (GAD-7) scale | A brief measure for assessing generalized anxiety disorder | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Quality of Life (WHOQOL-BREF) | The WHOQOL-BREF comprises of 26 items which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Satisfaction with life adolescent | measures global satisfaction with life | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Baseline (week 0) |
| Intent to Attend | Measures how likely and how motivated the participants is to attend the next session. | Baseline (week 0) |
| Participant Feedback - Program Satisfaction Questionnaire | Measures how satisfied the participant is with the intervention | Post-intervention (week 8) |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |