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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03176576
Enrollment
28
Registered
2017-06-05
Start date
2017-06-13
Completion date
2021-08-20
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

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.

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.

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.

OTHERPatient Navigator Satisfaction Survey

Evaluation of Patient Navigator intervention process.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Satisfaction with Patient NavigatorUpon completion of follow-up questionnaires and satisfaction surveys - up to 24 monthsRate of participants reporting satisfaction with the patient navigator service, based on survey response scores.

Secondary

MeasureTime frameDescription
Rate of Improved Questionnaire ScoresUpon completion of follow-up questionnaires and satisfaction surveys - up to 24 monthsFollow-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026