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

NCT03176576 | Completed

• 1 other identifier: MCC-18420
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Improved Questionnaire Scores

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

Study Arms (2)

Patient Navigator (PN)

EXPERIMENTAL

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.

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

Usual Care (UC)

OTHER

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.

Other: Baseline Questionnaire; Other: Follow-up Questionnaire

Interventions

Patient Navigator (PN) BEHAVIORAL

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.

Also known as: assistant

Patient Navigator (PN)

Baseline Questionnaire OTHER

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.

Also known as: survey

Patient Navigator (PN); Usual Care (UC)

Follow-up Questionnaire OTHER

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.

Also known as: survey

Patient Navigator (PN); Usual Care (UC)

Patient Navigator Satisfaction Survey OTHER

Evaluation of Patient Navigator intervention process.

Also known as: satisfaction survey

Patient Navigator (PN)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Navigation; Dental Assistants; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Dental Auxiliaries; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Dental Staff; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kristine Donovan, PhD, MBA

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 5, 2017
• Study Start: June 13, 2017
• Primary Completion: June 7, 2019
• Study Completion: August 20, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

US (1)