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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Patient Navigator (PN); Other: Baseline Questionnaire; Other: Follow-up Questionnaire; Other: Patient Navigator Satisfaction Survey

• Registration Number: NCT03176576
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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 Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-06-13
• Primary Completion: 2019-06-07
• Study Completion: 2021-08-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigator (PN)	Baseline Questionnaire	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.
Patient Navigator (PN)	Patient Navigator (PN)	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.
Patient Navigator (PN)	Follow-up Questionnaire	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.
Usual Care (UC)	Baseline Questionnaire	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.
Patient Navigator (PN)	Patient Navigator Satisfaction Survey	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.
Usual Care (UC)	Follow-up Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Rate of Satisfaction with Patient Navigator	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 Outcome Measures

Name	Time	Method
Rate of Improved Questionnaire Scores	Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months	Follow-up Questionnaire scores for Patient Navigator group vs. Control group, as compared to Baseline Questionnaire Scores. Distress Indicator: Rating of 0 to 10, with 0 being No Distress and 10 being Extreme Distress). Health and Well Being Rating Categories: General health; Activity limitations; Problems with regular activities; Frequency of physical or emotional problems. Satisfaction with Care: Rating of 1 to 5, with 1 being Strongly Disagree and 5 being Strongly Disagree for 29 questions. Service Use: Regarding information and informational resources provided at Moffitt Cancer Center.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States