- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02298270
Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02140
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 or older
- Can read and speak English at or above the 6th grade level
- Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis
Exclusion Criteria:
- Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
- Recent (within past 3 months) change in antidepressant medication
- Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
- Unable or unwilling to sign the informed consent documents
- Unable or unwilling to complete psychological assessments online via the REDCap system.
- Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Relaxation Response Resiliency Program
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
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8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills.
Topics include the relaxation response, meditation, and yoga.
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Placebo Comparator: Health Education
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.
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8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills.
Topics include the relaxation response, meditation, and yoga.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (WHOQOL-BREF)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Satisfaction with Life (SWL)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 14-Item Resiliency Scale (RS-14)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The RS-14 measures stress coping ability in the face of adversity.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Perceived Stress Scale (PSS-10)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Measure of Current Status (MOCS-A)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Interpersonal Reactivity Index (IRI)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The IRI assesses the cognitive and affective dimensions of empathy.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The Gratitude Questionnaire (GQ-6)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Life Orientation Test (LOT) Optimism Scale
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Medical Outcomes Study (MOS) Social Support Survey
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The MOS Social Support Survey measures various dimensions of social support.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Cognitive and Affective Mindfulness Scale (CAMS)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The CAMS measures the degree to which individuals experience their thoughts and feelings.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The Pain Catastrophizing Scale (PCS)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Pain Numerical Rating Scale (Pain NRS)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Patient Health Quesionnaire (PHQ)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The PHQ measures symptoms of depression and functional impairment.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Brief Pain Inventory (BPI)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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).
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Posttraumatic Growth Inventory (PGI)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Distress Analogue Scales
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.
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The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.
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Epworth Sleepiness Scale (ESS)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)
Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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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.
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Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana-Maria Vranceanu, PhD, MGH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Otorhinolaryngologic Neoplasms
- Otorhinolaryngologic Diseases
- Neurodegenerative Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Ear Diseases
- Nervous System Neoplasms
- Heredodegenerative Disorders, Nervous System
- Neoplastic Syndromes, Hereditary
- Cranial Nerve Diseases
- Neuroendocrine Tumors
- Nerve Sheath Neoplasms
- Neurocutaneous Syndromes
- Peripheral Nervous System Neoplasms
- Cranial Nerve Neoplasms
- Neuroma, Acoustic
- Neurilemmoma
- Neuroma
- Vestibulocochlear Nerve Diseases
- Retrocochlear Diseases
- Neurofibromatoses
- Neurofibromatosis 1
- Neurofibroma
- Neurofibromatosis 2
Other Study ID Numbers
- 2013P002605a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurofibromatosis
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University of UtahUniversity of British Columbia; Children's Hospital Medical Center, Cincinnati and other collaboratorsTerminatedNeurofibromatosis Type 1 (NF1)United States, Canada
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Johns Hopkins UniversityNeurofibromatosis Therapeutic Acceleration ProgramRecruitingNeurofibromatosis 1 | Neurofibromatosis Type 1 | Cutaneous Neurofibroma | Neurofibromatosis (Nonmalignant)United States
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National Cancer Institute (NCI)CompletedPlexiform Neurofibroma | Neurofibromatosis Type IUnited States
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University of Alabama at BirminghamCompletedNeurofibromatosis Type 1 and Growing or Symptomatic, Inoperable PNUnited States
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Novartis PharmaceuticalsTerminatedPlexiform Neurofibroma Associated With Neurofibromatosis Type 1Israel
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NYU Langone HealthNovartis Pharmaceuticals; The Children's Tumor FoundationCompletedNeurofibromatosis Type IIUnited States
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SpringWorks Therapeutics, Inc.Active, not recruitingPlexiform Neurofibroma | Neurofibromatosis Type 1 (NF1)United States
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AstraZenecaCompletedHealthy Participants | Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)United States
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SpringWorks Therapeutics, Inc.AvailableNeurofibromatosis Type 1-Associated Plexiform Neurofibromas | Histiocytic Neoplasm | Other MAP-K Pathway Driven Diseases
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AstraZenecaRecruitingNeurofibromatosis Type 1Portugal, Spain, United Kingdom, Israel, France, Italy, Switzerland, Germany, Austria
Clinical Trials on The Relaxation Response Resiliency Program (3RP) via Skype
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Dana-Farber Cancer InstituteCompletedMonoclonal Gammopathy of Undetermined Significance | Smoldering Multiple MyelomaUnited States
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Massachusetts General HospitalBenson-Henry Institute for Mind Body MedicineCompletedDepression | Quality of Life | Stress | Atrial Fibrillation | Anxiety | HostilityUnited States
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Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)CompletedResilience, PsychologicalUnited States
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Massachusetts General HospitalAmerican Cancer Society, Inc.Completed
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Massachusetts General HospitalThe Rappaport Foundation; The Claflin Distinguished Scholar AwardsNot yet recruitingVon Hippel-Lindau Disease | Genetic DisorderUnited States
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Massachusetts General HospitalUnknownStress | Burnout, ProfessionalUnited States
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Bay Cove Human Services; VinfenEnrolling by invitationDepression | Stress | Burnout | Sleep | Anxiety | Coping Skills | Physical Inactivity | Healthy EatingUnited States
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Stony Brook UniversityNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedPTSD | Signs and Symptoms, RespiratoryUnited States
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Massachusetts General HospitalCompletedStress | Paroxysmal Atrial FibrillationUnited States
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Massachusetts General HospitalUnknownPain | Chronic Pain | Physical ActivityUnited States