Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Neurofibromatosis 2 Clinical Trial

Official title:

Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298270
• Other study ID #: 2013P002605a
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: June 21, 2016
• Start date: March 2014
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study tests the efficacy of an 8-week, Skype-based, group resiliency training intervention (The Relaxation Response Resiliency Program) for improving psychological stress in patients with Neurofibromatosis. A control group will receive a general health education curriculum. The investigators hypothesize that patients will improve on measures of psychological stress as a result of the resiliency program.

A substudy (Unique Protocol ID: 2013P002605b) has been approved to test this study on a sub-population: patients with NF2 who are hard of hearing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis
• Neurofibromatosis 1
• Neurofibromatosis 2
• Neurofibromatosis I
• Schwannomatosis

Intervention

Behavioral:
• The Relaxation Response Resiliency Program (3RP) via Skype
8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.

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
Primary	Satisfaction with Life (SWL)	The Satisfaction with Life (SWL) scale is a reliable and valid 5-item self-report measure of global life satisfaction. 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)	No
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)	No
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)	No
Secondary	The Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Pain Numerical Rating Scale (Pain NRS)	The Pain NRS is a scale for patient self-reporting measurements of pain. The measure was depicted by REINS as a standard measure to use in Neurofibromatosis clinical trials.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Patient Health Quesionnaire (PHQ)	The PHQ measures symptoms of depression and functional impairment.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Brief Pain Inventory (BPI)	The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain (BPI-S) and the degree to which their pain interferes with common dimensions of feeling and function (BPI-I).	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
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)	No
Secondary	Posttraumatic Growth Inventory (PGI)	The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Interpersonal Reactivity Index (IRI)	The IRI assesses the cognitive and affective dimensions of empathy.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Distress Analogue Scales	The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session.	No
Secondary	Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
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)	No
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)	No
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)	No
Secondary	Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue)	The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
Secondary	Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp)	The FACIT-Sp measures participants' spiritual well-being (sense of meaning in life and the sense of strength in one's faith) over the past 7 days.	Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32)	No
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)	No
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)	No