Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT01775332

Conditions

Pituitary Neoplasms

Prolactinoma

ACTH-Secreting Pituitary Adenoma

Gigantism

Growth Hormone-Secreting Pituitary Adenoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Educational Intervention

Study Details

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.

Conditions

Pituitary Neoplasms

Prolactinoma

ACTH-Secreting Pituitary Adenoma

Gigantism

Growth Hormone-Secreting Pituitary Adenoma

Study ID

NCT01775332

Start date

Feb, 2014

Status verified date

Jul, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Educational Intervention

Educational Intervention - Access to educational materials provided (i.e. website, videos, brochure)

no intervention: No Intervention/Use of Own Resources

No educational materials are provided to participants, but they can use their own resources

Interventions

Educational Intervention

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

  • 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 ]

Central Contacts and Locations

Central contacts

Stanley Zhang, B.M.

416-864-5312injuryprevention@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1T8

Contacts

Stanley Zhang, B.M.

416-864-5312injuryprevention@smh.ca

Principal Investigator:

Michael Cusimano, MD, PhD

More Information

Sponsor

Unity Health Toronto

Last update posted

Jul 31, 2015

Last verified

Jul, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2015-07-31.