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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02811718
Other study ID # 2013P002605b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date July 2018

Study information

Verified date August 2018
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital The Children's Tumor Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Intent to Attend Measures how likely and how motivated the participants is to attend the next session. Baseline (week 0)
Other 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)
Other Credibility Questionnaire Measures how much the participant believes the intervention will work. Baseline (week 0)
Other Client Satisfaction Questionnaire (CSQ-8) Measures how satisfied the participant is with the intervention. Post-intervention (week 8)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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