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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Cancer

Treatments: Other: Follow-up Questionnaire; Behavioral: Patient Navigator (PN); Other: Baseline Questionnaire; Other: Patient Navigator Satisfaction Survey

Study type: Interventional

Funder types: Other

Identifiers

NCT03176576

MCC-18420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Patient Navigator (PN)

Experimental group

Description:

Patient Navigator (PN) Intervention Group. In addition to the Baseline Questionnaire and the Follow-up Questionnaire, PN intervention participants will complete a brief Patient Navigator Satisfaction Survey.

Treatment:

Other: Patient Navigator Satisfaction Survey

Other: Baseline Questionnaire

Behavioral: Patient Navigator (PN)

Other: Follow-up Questionnaire

Usual Care (UC)

Other group

Description:

Usual Care (UC) Control Group. Control sample of patients not receiving PN intervention will complete a Baseline Questionnaire and the six-week Follow-up Questionnaire. Participants under UC will have access to all services typically provided to Moffitt Cancer Center (MCC) patients. Any baseline distress score greater than three will be reported to the patient's primary oncologist and clinic nurse.

Treatment:

Other: Baseline Questionnaire

Other: Follow-up Questionnaire