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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-17-1-0121 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.
The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress and Symptom Management Program 1 | Experimental | The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing. |
|
| Stress and Symptom Management Program 2 | Experimental | The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress and Symptom Management Program 1 | Behavioral | The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Quality of Life | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Change in Psychological Quality of Life | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Social Quality of Life | World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Environmental Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40773151 | Derived | Brewer JR, Hooker JE, Kanaya M, LaCamera DE, Bakhshaie J, Vranceanu AM. Social support moderates quality of life outcomes during a mind-body intervention among adults with neurofibromatosis. J Neurooncol. 2025 Oct;175(1):133-141. doi: 10.1007/s11060-025-05108-8. Epub 2025 Aug 7. | |
| 39917761 | Derived | Hooker JE, Doorley JD, Greenberg J, Bakhshaie J, Manglani HR, Briskin EA, Vranceanu AM. Improvements in pain interference among geographically diverse adults with neurofibromatosis: Results from a fully powered randomized controlled trial. Neurooncol Pract. 2024 Sep 20;12(1):58-67. doi: 10.1093/nop/npae084. eCollection 2025 Feb. |
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| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009456 | Neurofibromatosis 1 |
| D016518 | Neurofibromatosis 2 |
| C536641 | Schwannomatosis |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
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|
| Stress and Symptom Management Program 2 | Behavioral | The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing. |
|
|
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
| 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Depression | Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Anxiety | Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Social Support | Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Gratitude | Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Optimism | Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Coping Strategies | Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Mindfulness | Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Empathy | Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Pain Intensity | Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Pain Interference | PROMIS Pain Interference; 8-40; higher scores indicate more pain interference | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| Stress | Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress | 0 Weeks, 8 Weeks, 6 Months, 12 Months |
| 38318960 | Derived | McDermott K, Bakhshaie J, Brewer J, Vranceanu AM. The impact of a virtual mind-body program on symptoms of depression and anxiety among international English-speaking adults with neurofibromatosis. Am J Med Genet A. 2024 Jun;194(6):e63543. doi: 10.1002/ajmg.a.63543. Epub 2024 Feb 6. |
| 37440099 | Derived | Presciutti AM, Lester EG, Woodworth EC, Greenberg J, Bakhshaie J, Hooker JE, McDermott KA, Vranceanu AM. The impact of a virtual mind-body program on resilience factors among international English-speaking adults with neurofibromatoses: secondary analysis of a randomized clinical trial. J Neurooncol. 2023 Jul;163(3):707-716. doi: 10.1007/s11060-023-04389-1. Epub 2023 Jul 13. |
| 37378983 | Derived | Vranceanu AM, Manglani HR, Choukas NR, Kanaya MR, Lester E, Zale EL, Plotkin SR, Jordan J, Macklin E, Bakhshaie J. Effect of Mind-Body Skills Training on Quality of Life for Geographically Diverse Adults With Neurofibromatosis: A Fully Remote Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320599. doi: 10.1001/jamanetworkopen.2023.20599. |
| 36651958 | Derived | Lester EG, Wang KE, Blakeley JO, Vranceanu AM. Occurrence and Severity of Suicidal Ideation in Adults With Neurofibromatosis Participating in a Mind-Body RCT. Cogn Behav Neurol. 2023 Mar 1;36(1):19-27. doi: 10.1097/WNN.0000000000000332. |
| 35925531 | Derived | Fishbein NS, Vranceanu AM, Mace RA. Baseline characteristics of adults with neurofibromatosis enrolled on a psychosocial randomized controlled trial. J Neurooncol. 2022 Sep;159(3):637-646. doi: 10.1007/s11060-022-04104-6. Epub 2022 Aug 4. |
| 35064449 | Derived | Bannon SM, Hopkins SW, Grunberg VA, Vranceanu AM. Psychosocial profiles of risk and resiliency in neurofibromatoses: a person-centered analysis of illness adaptation. J Neurooncol. 2022 Feb;156(3):519-527. doi: 10.1007/s11060-021-03928-y. Epub 2022 Jan 22. |
| 34570301 | Derived | Mace RA, Doorley J, Bakhshaie J, Cohen JE, Vranceanu AM. Psychological resiliency explains the relationship between emotional distress and quality of life in neurofibromatosis. J Neurooncol. 2021 Nov;155(2):125-132. doi: 10.1007/s11060-021-03852-1. Epub 2021 Sep 27. |
| 34409538 | Derived | Doorley JD, Greenberg J, Bakhshaie J, Fishbein NS, Vranceanu AM. Depression explains the association between pain intensity and pain interference among adults with neurofibromatosis. J Neurooncol. 2021 Sep;154(2):257-263. doi: 10.1007/s11060-021-03826-3. Epub 2021 Aug 19. |
| 32421171 | Derived | Lester EG, Gates MV, Vranceanu AM. Mind-Body Therapy via Videoconferencing in Patients With Neurofibromatosis: Analyses of 1-Year Follow-up. Ann Behav Med. 2021 Feb 12;55(1):77-81. doi: 10.1093/abm/kaaa030. |
| 30355560 | Derived | Vranceanu AM, Zale EL, Funes CJ, Macklin EA, McCurley J, Park ER, Jordan JT, Lin A, Plotkin SR. Mind-Body Treatment for International English-Speaking Adults With Neurofibromatosis via Live Videoconferencing: Protocol for a Single-Blind Randomized Controlled Trial. JMIR Res Protoc. 2018 Oct 23;7(10):e11008. doi: 10.2196/11008. |
| 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 |