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Trial record 32 of 120 for:    medullary carcinoma

Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892993
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE March 27, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2019)
  • The needs of the assessment will be assessed by the patients, caregiver and providers. [ Time Frame: Up to 1 year ]
    The research team will tabulate and summarize responses to the needs assessment questionnaire to identify priority design needs, and review open text areas for notable suggestions.
  • Decision aid design refining (storyboarding) Questionairre [ Time Frame: Up to 1 year ]
    During storyboarding, the research team will iteratively review the interviewers' notes regarding participant feedback, identify predominant recommendations for improvement, and make decisions to refine the decision aid design.
  • Decision aid acceptability: acceptability questionnaire [ Time Frame: Up to 1 year post decision aid ]
    The research team will review the Think Aloud interview notes for potential opportunities for improvement. Responses to the post‐decision aid acceptability questionnaire will be tabulated and summarized into tables for publication and presentation using Excel. The Stakeholder Advisory Panel will review responses to the post‐decision aid acceptability questionnaire, to confirm that viewing the decision aid provides a balanced presentation of the options and is not likely to bias patients'/survivors' initial preferences.
Original Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Patient decision-making support needs [ Time Frame: Up to 1 year ]
    This outcome will be assessed used mixed methods as adapted from the Ottawa Population Needs Assessment Workbook (Jacobsen & O'Connor 1999), including a) quantitative tabulation of responses to a tailored patient decision-aid needs assessment questionnaire supplemented by b) qualitative review of open-ended questions.
  • Suggestions for improvement [ Time Frame: Up to 1 year ]
    This outcome will be assessed using qualitative "story-boarding" process - we will present iterative cycles of participants with paper mock-ups (story-boards) of the proposed content and design and ask semi-structured open-ended prompts to request their feedback.
  • Acceptability [ Time Frame: Up to 1 year post decision-aid ]
    Ottawa Patient Decision Aid Acceptability Scale, adapted for this clinical context. (https://decisionaid.ohri.ca/eval_accept.html)
Change History Complete list of historical versions of study NCT03892993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers
Official Title  ICMJE Designing a Decision Aid to Help People With Medullary Thyroid Cancer Make Decisions With Their Doctors About Whether to Start or Stop New Drugs, Enroll in Clinical Trials, or Continue With Active Surveillance
Brief Summary This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.
Detailed Description

PRIMARY OBJECTIVES:

I. To assess patient, caregiver, and provider decision-making needs. II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability.

OUTLINE:

Participants use decision aid and complete questionnaire.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer Survivor
  • Caregiver
  • Family Member
  • Health Care Provider
  • Thyroid Gland Medullary Carcinoma
Intervention  ICMJE
  • Other: Decision Aid
    Use decision aid
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE Experimental: Supportive care (decision aid)
Participants use decision aid and complete questionnaires.
Interventions:
  • Other: Decision Aid
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years old or older
  • Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in their medical record or the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
  • Able to speak, read, and write English

Exclusion Criteria:

  • Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elizabeth G Grubbs 713-792-6940 eggrubbs@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03892993
Other Study ID Numbers  ICMJE 2018-0557
NCI-2019-00631 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0557 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Elizabeth G Grubbs M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP