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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176576
• Other study ID #: MCC-18420
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 20, 2021
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Patient Navigator (PN)
Patient navigation (PN) is an intervention model designed to assist vulnerable patients in overcoming health system, personal and/or logistical barriers to care throughout the cancer care continuum. The strategic aims of PN are to reduce barriers and improve disease outcomes while also reducing distress and enhancing quality of life for the patient and family. Participants in the PN group will meet with a patient navigator.

Other:
• Baseline Questionnaire
Complete a baseline questionnaire online or by meeting with a member of the study team. This questionnaire has items asking about the participant's health, distress levels, satisfaction with their care at Moffitt Cancer Center, and what support services they have used since their diagnosis. This questionnaire will take about 15 to 20 minutes of their time.
• Follow-up Questionnaire
After participants complete the baseline questionnaire, they will be asked to complete a follow-up questionnaire approximately 6 weeks from when they completed the baseline questionnaire. The follow-up questionnaire will take about 15 to 20 minutes to complete.
• Patient Navigator Satisfaction Survey
Evaluation of Patient Navigator intervention process.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Satisfaction with Patient Navigator	Rate of participants reporting satisfaction with the patient navigator service, based on survey response scores.	Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months
Secondary	Rate of Improved Questionnaire Scores	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.	Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months

External Links

•   Moffitt Cancer Center Clinical Trials website