Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
Primary Purpose
Pituitary Neoplasms, Prolactinoma, ACTH-Secreting Pituitary Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Pituitary Neoplasms
Eligibility Criteria
Inclusion Criteria:
- age equal to or greater than 18 years;
- capable of providing consent to participate on their own behalf;
- diagnosed with a pituitary disorder OR have a history of pituitary disorder AND a current/former patient at St. Michael's Hospital, OR be a caretaker of someone with a pituitary disorder;
- adequate written/verbal English skills.
Exclusion Criteria:
- Younger than 18 years;
- Unable to provide consent;
- Unable to communicate in written/verbal English, as all of the surveys and interviews are administered in English
Sites / Locations
- St. Michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Intervention
No Intervention/Use of Own Resources
Arm Description
Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)
No educational materials are provided to participants, but they can use their own resources
Outcomes
Primary Outcome Measures
The level of knowledge that patients have of their condition before and after reviewing the materials provided, and ease of use of educational materials and user satisfaction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01775332
Brief Title
Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
Official Title
Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to determine the utility of educational materials designed to inform patients of their pituitary condition, in an effort to assist the patients, families, and staff deal with pituitary tumours and related conditions in the best way possible. We have developed a website, informational videos, and a brochure for pituitary tumour patients and their families. The primary outcome measures will be 1) the level of knowledge that patients have of their condition before and after reviewing the materials provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our informative multimedia educational package will not only improve the health literacy and self-efficacy of patients and their families, but will also improve quality of care.
Detailed Description
This study involves a formative evaluation of the health literacy resources that we have already developed. We see approximately 60 new patients a year with pituitary disorders, plus the follow-up patients: all of these patients will be offered the opportunity to participate in the study. These materials include a website (containing videos, illustrations and written materials) and plain language educational brochures. The educational materials include information that patients will need throughout their experience with a pituitary tumour, ranging from the signs and symptoms of tumours, to long-term post-operative lifestyle changes. This evaluation will be a mixed-methods evaluation.
Part A (Think aloud) will use "think-aloud" processes to evaluate the usefulness and ease of use of a website that we have developed with patients and their families.
Part B (Resource assessment) will involve the use of questionnaires followed by semi-structured interviews with patients and families before and after using the resources.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Neoplasms, Prolactinoma, ACTH-Secreting Pituitary Adenoma, Gigantism, Growth Hormone-Secreting Pituitary Adenoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)
Arm Title
No Intervention/Use of Own Resources
Arm Type
No Intervention
Arm Description
No educational materials are provided to participants, but they can use their own resources
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
A brochure and access to a website including videos that contain detailed information about pituitary disorders will serve as the educational intervention.
Primary Outcome Measure Information:
Title
The level of knowledge that patients have of their condition before and after reviewing the materials provided, and ease of use of educational materials and user satisfaction
Time Frame
1-2 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age equal to or greater than 18 years;
capable of providing consent to participate on their own behalf;
diagnosed with a pituitary disorder OR have a history of pituitary disorder AND a current/former patient at St. Michael's Hospital, OR be a caretaker of someone with a pituitary disorder;
adequate written/verbal English skills.
Exclusion Criteria:
Younger than 18 years;
Unable to provide consent;
Unable to communicate in written/verbal English, as all of the surveys and interviews are administered in English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley Zhang, B.M.
Phone
416-864-5312
Email
injuryprevention@smh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Cusimano, MD, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Zhang, B.M.
Phone
416-864-5312
Email
injuryprevention@smh.ca
First Name & Middle Initial & Last Name & Degree
Michael Cusimano, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17931131
Citation
Andrulis DP, Brach C. Integrating literacy, culture, and language to improve health care quality for diverse populations. Am J Health Behav. 2007 Sep-Oct;31 Suppl 1(Suppl 1):S122-33. doi: 10.5555/ajhb.2007.31.supp.S122.
Results Reference
background
PubMed Identifier
16583727
Citation
Kan P, Cusimano M. Validation of a quality-of-life questionnaire for patients with pituitary adenoma. Can J Neurol Sci. 2006 Feb;33(1):80-5. doi: 10.1017/s0317167100004741.
Results Reference
background
Citation
Goguen, J. (2007). Perioperative management of the pituitary patients. Endocrinology Rounds, 7(9): 1-6. Retrieved February 2, 2011 from http://www.endocrinologyrounds.ca
Results Reference
background
Learn more about this trial
Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools
We'll reach out to this number within 24 hrs