The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.
The aims of this study are to compare the effect of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. We will also examine the degree to which treatment-dependent improvements in quality of life are mediated by improvements in depression, anxiety, distress, mindfulness, gratitude, social support, empathy, optimism, coping, pain intensity and pain interference.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
228
The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Physical Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Change in Psychological Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Social Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Environmental Quality of Life
World Health Organization Quality of Life Brief (WHOQOL-BREF); 4-20; higher score indicates higher QoL
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Depression
Patient Health Questionnaire 9-Item (PHQ-9); 0-27; higher score indicates more symptoms of depression
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Anxiety
Generalized Anxiety Disorder 7-Item (GAD-7); 0-21; higher score indicates more symptoms of anxiety
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Social Support
Medical Outcome Study Social Support Survey (MOS); 18-90; higher scores indicate greater perceived social support
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
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Gratitude
Gratitude Questionnaire 6-Item (GQ-6); 6-42; higher scores indicate greater gratitude
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Optimism
Life Orientation Test-Revised (LOT-R); 0-40; higher scores indicate greater optimism
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Coping Strategies
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Mindfulness
Cognitive and Affective Mindfulness Scale (CAMS); 10-40; higher scores indicate greater mindfulness
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Empathy
Interpersonal Reactivity Index (IRI) Empathy Subscale; 7-Items; 0-28; higher scores indicate greater empathy
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Pain Intensity
Graded Chronic Pain Scale (GCPS); 0-100; higher scores indicate greater pain intensity
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Pain Interference
PROMIS Pain Interference; 8-40; higher scores indicate more pain interference
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months
Stress
Perceived Stress Scale 10-Item (PSS-10); 0-21; higher scores indicate greater levels of perceived stress
Time frame: 0 Weeks, 8 Weeks, 6 Months, 12 Months