NeurofibromatosisNCT02435628
Relationship Between Psychosocial Factors, Health Literacy, Quality of Life and Satisfaction With Medical Visits in Adults With NF
An observational study of Neurofibromatosis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis
- What is being tested?
- Questionnaires
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
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.
- Conditions
- Neurofibromatosis
- Being tested
- Questionnaires
- Medical subject headings
- Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Satisfaction Questionnaires | 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS)
A 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.
Measured: Baseline (pre-medical visit)
Functional, Communicative and Critical Health Literacy (FFFHL) scale
Measures one's health literacy, the capacity of individuals to access, understand, and use health information to make informed and appropriate health-related decisions.
Measured: Baseline (pre-medical visit)
Medical Interview Satisfaction Scale (MISS)
Measures patient satisfaction with individual doctor-patient consultations.
Measured: 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
Asks patients to report on and evaluate their experiences with health care. This survey covers topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.
Measured: Participants will be followed for the duration of their medical visit, an expected average of no more than 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofibromatosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435628
- Sponsor's protocol ID
- 2014P002755
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02435628
- Acronym / sponsor ID
- 2014P002755
- Conditions
- Neurofibromatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Satisfaction Questionnaires | – | Other: QuestionnairesAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with neurofibromatosis 1, neurofibromatosis 2, or schwannomatosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAll 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. | Other | Satisfaction Questionnaires |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline (pre-medical visit)
A 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.
Functional, Communicative and Critical Health Literacy (FFFHL) scale
Time frame: Baseline (pre-medical visit)
Measures one's health literacy, the capacity of individuals to access, understand, and use health information to make informed and appropriate health-related decisions.
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.
Measures patient satisfaction with individual doctor-patient consultations.
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.
Asks patients to report on and evaluate their experiences with health care. This survey covers topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) (time frame: Baseline (pre-medical visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.