Clinical trial NCT03176576: Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population
Official title: Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer among adolescents
cancer among young adults
adolescents and young adults (AYA)
quality of life
reduce stress
patient navigation
questionnaire
supportive care
distress levels
support resources
satisfaction survey
teen cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Satisfaction with Patient Navigator
timeFrame: Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months
Secondary outcomes:
measure: Rate of Improved Questionnaire Scores
timeFrame: Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Kristine Donovan, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: