Clinical Trial: Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

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.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: June 21, 2016
Date Started: July 2016
Date Completion: June 2018
Last Updated: April 2, 2017
Last Verified: April 2017