Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With… (NCT02435628) | Clinical Trial Compass
CompletedNot Applicable
Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With NF
United States86 participantsStarted 2015-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 or older
. Can read and speak English at or above the 6th grade level
. Diagnosis of neurofibromatosis type 1, neurofibromatosis type 2, or schwannomatosis
Exclusion criteria
. 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)
. Unable or unwilling to participate
. Unable or unwilling to complete psychological assessments online via the REDCap or Assessment Center systems.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Reported Outcomes Measurement Information System (PROMIS)
Timeframe: Baseline (pre-medical visit)
2
Functional, Communicative and Critical Health Literacy (FFFHL) scale
Timeframe: Baseline (pre-medical visit)
3
Medical Interview Satisfaction Scale (MISS)
Timeframe: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
4
Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey
Timeframe: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.