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Completed

NCT Number: NCT02811718

Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

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.

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Key information

Conditions

Neurofibromatosis 2 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatoses Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Retrocochlear Diseases Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.
  • Unwilling to use either CART or ASL for communication during the Skype groups.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Children's Tumor Foundation

Registry information

Official study title

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2016
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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