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

September 13, 2021 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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 Names:
  • assistant
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.
Other Names:
  • survey
Other: 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.
Other Names:
  • survey
Other: Patient Navigator Satisfaction Survey
Evaluation of Patient Navigator intervention process.
Other Names:
  • satisfaction survey
OTHER: Usual Care (UC)
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
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.
Other Names:
  • survey
Other: 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.
Other Names:
  • survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Satisfaction with Patient Navigator
Time Frame: 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.
Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Improved Questionnaire Scores
Time Frame: 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.
Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Kristine Donovan, PhD, MBA, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 13, 2017

Primary Completion (ACTUAL)

June 7, 2019

Study Completion (ACTUAL)

August 20, 2021

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCC-18420

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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