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| Name | Class |
|---|---|
| The Children's Tumor Foundation | OTHER |
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This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.
A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxation Response Resiliency Program | Experimental | Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills. |
|
| Health Education | Placebo Comparator | Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Relaxation Response Resiliency Program (3RP) via Skype | Behavioral | 8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with Life (SWL) | The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) | The PSS is a widely used psychological instrument for the measurement of the perception of stress. This 10-itam scale is designed to measure the degree to which situations in one's life are appraised, or considered stressful. The scores range from 0-40, with a higher score indicating higher perceived stress. Items were designed to detect how unpredictable, uncontrollable and overloaded respondents find their lives. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02140 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2026 | |
| Reset | Feb 26, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2026 | Feb 26, 2026 |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009456 | Neurofibromatosis 1 |
| D016518 | Neurofibromatosis 2 |
| C536641 | Schwannomatosis |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
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| Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Pain Numerical Rating Scale (Pain NRS) | The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Patient Health Quesionnaire (PHQ) | The PHQ measures symptoms of depression and functional impairment. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Brief Pain Inventory (BPI) | The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I). | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Cognitive and Affective Mindfulness Scale (CAMS) | The CAMS measures the degree to which individuals experience their thoughts and feelings. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Posttraumatic Growth Inventory (PGI) | The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Interpersonal Reactivity Index (IRI) | The IRI assesses the cognitive and affective dimensions of empathy. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Distress Analogue Scales | The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session. |
| Epworth Sleepiness Scale (ESS) | The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Measure of Current Status (MOCS-A) | The MOCS-A is a 13-item measure assessing participants' current self-perceived status on several skills such as: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Responses are made on a 7-point scale with higher scores reflecting higher life satisfaction. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Life Orientation Test (LOT) Optimism Scale | The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The Gratitude Questionnaire (GQ-6) | The GQ-6 revised is a 6-item measure that assesses individual differences in the proneness to experience gratitude in daily life. Scores range from 6-42, with a higher score indicating a greater sense of gratitude. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue) | The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp) | The FACIT-Sp measures participants' 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) |
| Medical Outcomes Study (MOS) Social Support Survey | The MOS Social Support Survey measures various dimensions of social support. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| The 14-Item Resiliency Scale (RS-14) | The RS-14 measures stress coping ability in the face of adversity. | Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) |
| 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 |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009464 | Neuroma, Acoustic |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009463 | Neuroma |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |