Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

Resiliency Training for Patients With Neurofibromatosis 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.

Study Overview

• Status: Completed
• Conditions: Neurofibromatosis 2
• Intervention / Treatment: Behavioral: Stress Management Group 1; Behavioral: Stress Management Group 2

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 14-Item Resiliency Scale (RS-14)	The RS-14 measures stress coping ability in the face of adversity.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Perceived Stress Scale (PSS-10)	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.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Measure of Current Status (MOCS-A)	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.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
The Gratitude Questionnaire (GQ-6)	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.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Life Orientation Test (LOT) Optimism Scale	The LOT Optimism Scale measures individual differences in generalized optimism versus pessimism.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Medical Outcomes Study (MOS) Social Support Survey	The MOS Social Support Survey measures various dimensions of social support.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Patient Health Questionnaire (PHQ)	The PHQ measures symptoms of depression and functional impairment.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)
Cognitive and Affective Mindfulness Scale (CAMS)	The CAMS measures the degree to which individuals experience their thoughts and feelings.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility Questionnaire	Measures how much the participant believes the intervention will work.	Baseline (week 0)
Intent to Attend	Measures how likely and how motivated the participants is to attend the next session.	Baseline (week 0)
Date of Birth, Age, Gender, Race, Ethnicity, Marital Status, Education Status, Employment Status, and hearing status of subjects with NF2	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.	Baseline (week 0)
Client Satisfaction Questionnaire (CSQ-8)	Measures how satisfied the participant is with the intervention.	Post-intervention (week 8)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: The Children's Tumor Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (ESTIMATE): June 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Stress Management; Resiliency; Skype
• 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: 2013P002605b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED