跳至主要内容
临床试验/NCT03176576
NCT03176576已完成不适用

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

H. Lee Moffitt Cancer Center and Research Institute1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Rate of Satisfaction with Patient Navigator

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Does not meet any of the Inclusion Criteria.

研究组 & 干预措施

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.

干预措施: Patient Navigator (PN) (Behavioral)

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.

干预措施: Patient Navigator Satisfaction Survey (Other)

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.

干预措施: Baseline Questionnaire (Other)

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.

干预措施: Follow-up Questionnaire (Other)

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.

干预措施: Baseline Questionnaire (Other)

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.

干预措施: Follow-up Questionnaire (Other)

结局指标

主要结局

Rate of Satisfaction with Patient Navigator

时间窗: 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.

次要结局

  • Rate of Improved Questionnaire Scores(Upon completion of follow-up questionnaires and satisfaction surveys - up to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验