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Clinical Trials/NCT03176576
NCT03176576CompletedNot Applicable

Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population

H. Lee Moffitt Cancer Center and Research Institute2 sites in 1 country28 target enrollmentStarted: June 13, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
Rate of Satisfaction with Patient Navigator

Study Overview

Brief Summary

The purpose of this study is to develop and test a model of patient navigation that investigators hope will address the unique needs of adolescent and young adult (AYA) cancer patients and their families by minimizing barriers in their care and potentially improving the outcomes of their treatment while reducing distress and enhancing quality of life. Investigators plan to achieve this by increasing access to, and use of, the resources available at Moffitt Cancer Center for AYA patients and their families.

Detailed Description

Up to 80 participants may be recruited to this study at Moffitt Cancer Center to obtain a final sample size of 60 completed participants.

Participants will be identified in consultation with the patient's primary oncologist and program social worker. A research assistant (RA) will verify eligibility and consent eligible patients.

After completing a baseline questionnaire, participants will be randomly placed into one of two groups. Both groups will receive their normal care, but one group will also meet with a patient navigator. Participants in both groups will be asked to complete a follow-up questionnaire approximately 8 to 10 weeks from when they complete the baseline questionnaire. The follow-up questionnaire will take about 15 to 20 minutes to complete.

Participation in the study will last about 10 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients 18 to 39 years old.
  • Will undergo chemotherapy and/or radiotherapy and/or surgery with no plans to undergo a transplant procedure within the next 3 months.
  • Have no previous cancer history other than non-melanoma skin cancer.
  • Able to speak and read English.
  • Able to provide written informed consent.

Exclusion Criteria

  • Does not meet any of the Inclusion Criteria.

Outcomes

Primary Outcomes

Rate of Satisfaction with Patient Navigator

Time Frame: Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months

Rate of participants reporting satisfaction with the patient navigator service, based on survey response scores.

Secondary Outcomes

  • Rate of Improved Questionnaire Scores(Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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