Patient Navigation in the Adolescent and Young Adult (AYA) Cancer Population
NCT ID: NCT03176576
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2017-06-13
2021-08-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
39 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Kristine Donovan, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-18420
Identifier Type: -
Identifier Source: org_study_id
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