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Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02298270
First Posted: November 21, 2014
Last Update Posted: June 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Children's Tumor Foundation
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
  Purpose

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.


Condition Intervention
Neurofibromatosis Neurofibromatosis I Neurofibromatosis 2 Schwannomatosis Behavioral: The Relaxation Response Resiliency Program (3RP) via Skype

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Resiliency Training for Patients With Neurofibromatosis Via Videoconferencing With Skype

Resource links provided by NLM:


Further study details as provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Satisfaction with Life (SWL) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  • Quality of Life (WHOQOL-BREF) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.


Secondary Outcome Measures:
  • 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 Pain Catastrophizing Scale (PCS) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The Pain Catastrophizing Scale (PCS) is widely used to assess cognitive and affective responses to pain and to evaluate pain management program outcomes.

  • Pain Numerical Rating Scale (Pain NRS) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  • Patient Health Quesionnaire (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.

  • Brief Pain Inventory (BPI) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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).

  • 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.

  • Posttraumatic Growth Inventory (PGI) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The PGI is an instrument for assessing positive outcomes reported by persons who have experienced traumatic events.

  • Interpersonal Reactivity Index (IRI) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The IRI assesses the cognitive and affective dimensions of empathy.

  • Distress Analogue Scales [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32). Also administered at mid-interevention, before each group session. ]
    The Distress Analogue Scales measure participants' levels of stress, coping, distress, and discomfort.

  • Epworth Sleepiness Scale (ESS) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The Epworth Sleepiness Scale (ESS) has been widely used to assess a person's average level of daytime sleepiness in daily life.

  • 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.

  • 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.

  • Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    The FACIT-Fatigue measures participants' tiredness, weakness, and difficulty conducting usual activities due to fatigue.

  • Functional Assessment of Chronic Illness Therapy- Spirituality Scale (FACIT-Sp) [ Time Frame: Change between Baseline (week 0), Post-intervention (week 8) and Follow Up (week 32) ]
    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.

  • 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.

  • 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.


Enrollment: 65
Study Start Date: March 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relaxation Response Resiliency Program
Participants will receive an 8-week behavioral intervention which teaches stress management and psychological resiliency-enhancing skills.
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.
Placebo Comparator: Health Education
Participants will receive and 8-week general stress and health education program, with none of the active relaxation and resiliency-based components being tested in the experimental condition.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02298270


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02140
Sponsors and Collaborators
Massachusetts General Hospital
The Children's Tumor Foundation
Investigators
Principal Investigator: Ana-Maria Vranceanu, PhD MGH
  More Information

Responsible Party: Ana-Maria Vranceanu, PhD, Dr., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02298270     History of Changes
Other Study ID Numbers: 2013P002605a
First Submitted: November 17, 2014
First Posted: November 21, 2014
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Neurofibromatosis
NF I
NF 2
Schwannomatosis
Stress Management
Resiliency
Skype

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibromatosis 2
Neurofibromatosis 1
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuroma, Acoustic
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Neoplasms