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Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

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ClinicalTrials.gov Identifier: NCT02811718
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
The Children's Tumor Foundation
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

Brief Summary:

The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are deaf or have severe hearing loss using Communication Access Realtime Translation (CART) and/or American Sign Language (ASL).

This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study except it is looking at a particular sub-population: patients with NF2 who are hard of hearing.


Condition or disease Intervention/treatment Phase
Neurofibromatosis 2 Behavioral: Stress Management Group 1 Behavioral: Stress Management Group 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype
Actual Study Start Date : July 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Stress Management Group 1
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Behavioral: Stress Management Group 1
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.

Experimental: Stress Management Group 2
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
Behavioral: Stress Management Group 2
Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.




Primary Outcome Measures :
  1. Quality of Life (WHOQOL-BREF) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64) ]
    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.

  2. Penn Acoustic Neuroma Quality-of Life Scale (PANQOL) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32 and week 64) ]
    The PANQOL measures quality of life specifically for patients with NF2.


Secondary Outcome Measures :
  1. Perceived Stress Scale (PSS-10) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  2. The 14-Item Resiliency Scale (RS-14) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The RS-14 measures stress coping ability in the face of adversity.

  3. Patient Health Questionnaire (PHQ) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The PHQ measures symptoms of depression and functional impairment.

  4. Cognitive and Affective Mindfulness Scale (CAMS) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The CAMS measures the degree to which individuals experience their thoughts and feelings.

  5. Life Orientation Test (LOT) Optimism Scale [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.

  6. The Gratitude Questionnaire (GQ-6) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  7. Measure of Current Status (MOCS-A) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  8. Medical Outcomes Study (MOS) Social Support Survey [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The MOS Social Support Survey measures various dimensions of social support.


Other Outcome Measures:
  1. Intent to Attend [ Time Frame: Baseline (week 0) ]
    Measures how likely and how motivated the participants is to attend the next session.

  2. Date of Birth, Age, Gender, Race, Ethnicity, Marital Status, Education Status, Employment Status, and hearing status of subjects with NF2 [ Time Frame: Baseline (week 0) ]
    This questionnaire asks subjects with NF2 to report their date of birth, age, gender, race, ethnicity, marital status, highest level of education, hearing status, and primary employment status over the last 12 months.

  3. Credibility Questionnaire [ Time Frame: Baseline (week 0) ]
    Measures how much the participant believes the intervention will work.

  4. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-intervention (week 8) ]
    Measures how satisfied the participant is with the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 or older
  2. Can read and speak English at or above the 6th grade level
  3. Patients with NF2 who are deaf or have severe hearing loss.

Exclusion Criteria:

  1. 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)
  2. Recent (within past 3 months) change in antidepressant medication
  3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
  4. Unable or unwilling to sign the informed consent documents
  5. Unable or unwilling to complete psychological assessments online via the REDCap system.
  6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
  7. Unwilling to use either CART or ASL for communication during the Skype groups.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811718


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
The Children's Tumor Foundation
Investigators
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Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital

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Responsible Party: Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02811718     History of Changes
Other Study ID Numbers: 2013P002605b
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Stress Management
Resiliency
Skype

Additional relevant MeSH terms:
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Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Neurofibromatosis 2
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms