This trial is active, not recruiting.

Condition neurofibromatosis
Treatment questionnaires
Sponsor Massachusetts General Hospital
Start date February 2015
End date September 2016
Trial size 86 participants
Trial identifier NCT02435628, 2014P002755


This is a prospective study through the NF clinic at Massachusetts General Hospital that will examine the relationship between psychosocial factors, health literacy, and satisfaction with the medical visit in adults with NF1, NF2, and Schwannomatosis. A total of 89 participants will be enrolled in the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
After enrollment, subjects will be given baseline measures to assess demographics, psychosocial factors, and health literacy. This assessment will occur online via Computerized Assessment Center. Participants will complete the PROMIS battery of measures assessing: depression, anxiety, anger, fatigue, pain behavior and interference, physical function, satisfaction with discretionary social activities, satisfaction with social roles, and health literacy. Participants will also complete the FFFHL scale. Upon completion of the baseline assessments, the participant will meet with their doctor at the NF clinic for a routine appointment. Post-treatment assessments will be administered immediately after completion of the medical visit. This assessment will evaluate the participant's satisfaction with the appointment in the NF clinic using the MISS and CAHPS surveys. This will be done online via REDCap.
All subjects will complete baseline psychological assessments prior to their medical visit. Upon completion of their routine medical visit, subjects will complete a post-test assessment measuring their satisfaction with the visit.

Primary Outcomes

Patient Reported Outcomes Measurement Information System (PROMIS)
time frame: Baseline (pre-medical visit)
Functional, Communicative and Critical Health Literacy (FFFHL) scale
time frame: Baseline (pre-medical visit)
Medical Interview Satisfaction Scale (MISS)
time frame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey
time frame: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.

Eligibility Criteria

Male or female participants at least 18 years old.

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. Unable or unwilling to participate 3. Unable or unwilling to complete psychological assessments online via the REDCap or Assessment Center systems.

Additional Information

Official title Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With Neurofibromatosis 1, Neurofibromatosis 2, and Schwannomatosis
Principal investigator Ana-Maria Vranceanu, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.