Trial record 7 of 67 for:    "familial isolated pituitary adenoma" OR "Pituitary Neoplasms"

Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Academic Health Science Centres Alternative Funding Plan (AFP) 2011-2012
Information provided by (Responsible Party):
Michael Cusimano, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01775332
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Pituitary Neoplasms
Prolactinoma
ACTH-Secreting Pituitary Adenoma
Gigantism
Growth Hormone-Secreting Pituitary Adenoma
Other: Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

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 [ Time Frame: 1-2 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational Intervention
Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)
Other: Educational Intervention
A brochure and access to a website including videos that contain detailed information about pituitary disorders will serve as the educational intervention.
No Intervention: No Intervention/Use of Own Resources
No educational materials are provided to participants, but they can use their own resources

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775332

Contacts
Contact: Emily Lam, MSc 416-864-5312 lamemi@smh.ca
Contact: Stanley Zhang, B.M. 416-864-5312 ZhangSh@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B1T8
Contact: Emily Lam, MSc    416-864-5312    lamemi@smh.ca   
Principal Investigator: Michael Cusimano, MD, PhD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Academic Health Science Centres Alternative Funding Plan (AFP) 2011-2012
Investigators
Principal Investigator: Michael Cusimano, MD, PhD St. Michael's Hospital, Toronto
  More Information

Publications:
Responsible Party: Michael Cusimano, MD, PhD, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01775332     History of Changes
Other Study ID Numbers: SMHAIF - 058
Study First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Pituitary Neoplasms
Adenoma
Neoplasms
Gigantism
Pituitary Diseases
Prolactinoma
Growth Hormone-Secreting Pituitary Adenoma
ACTH-Secreting Pituitary Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hyperpituitarism
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases

ClinicalTrials.gov processed this record on July 26, 2014