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临床试验/NCT03233555
NCT03233555已完成不适用

Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 535 人开始时间: 2013年9月3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
535
试验地点
2
主要终点
Use of preventive services

研究概览

简要总结

This study tests four different methods of educating patients about follow-up care (NCI facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS website & health coaching combination) after cancer treatment ends. While it is known that patients need information to guide follow-up it remains unknown how to best provide this in primary care.

详细描述

PRIMARY OBJECTIVES:

I. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up for cancer survivors.

II. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.

III. Assess/refine intervention usability and acceptability for primary care patients.

OUTLINE:

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have been diagnosed with localized breast or prostate (stages 1-2) or colorectal cancer (stage 1-3)
  • •Have completed active treatment for their cancer diagnosis (excluding hormonal therapy)
  • •Have access to a phone for contact with health coach
  • •Be able to communicate in English; and be competent to consent
  • •Usability Testing and the randomized control trial (RCT): have access to a computer, a smartphone or an i-Pad/tablet equivalent with internet access

排除标准

  • •Patients who are required because of their disease to see primarily oncologists for follow-up will be excluded (i.e., those diagnosed with lymph node or distant metastasis, those with a new primary cancer)

研究组 & 干预措施

Arm I (brochure)

Active Comparator

Participants receive National Cancer Institute's Facing Forward brochure.

干预措施: Quality-of-Life Assessment (Other)

Arm I (brochure)

Active Comparator

Participants receive National Cancer Institute's Facing Forward brochure.

干预措施: Questionnaire Administration (Other)

Arm IV (EXCELS website, health coaching calls)

Experimental

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

干预措施: Quality-of-Life Assessment (Other)

Arm I (brochure)

Active Comparator

Participants receive National Cancer Institute's Facing Forward brochure.

干预措施: Informational Intervention (Other)

Arm IV (EXCELS website, health coaching calls)

Experimental

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

干预措施: Questionnaire Administration (Other)

Arm IV (EXCELS website, health coaching calls)

Experimental

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

干预措施: Telephone-Based Intervention (Behavioral)

Arm II (EXCELS website)

Experimental

Participants have untimed access to the EXCELS mobile web application.

干预措施: Internet-Based Intervention (Other)

Arm II (EXCELS website)

Experimental

Participants have untimed access to the EXCELS mobile web application.

干预措施: Quality-of-Life Assessment (Other)

Arm II (EXCELS website)

Experimental

Participants have untimed access to the EXCELS mobile web application.

干预措施: Questionnaire Administration (Other)

Arm III (Healthcare coaching call)

Experimental

Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care.

干预措施: Quality-of-Life Assessment (Other)

Arm III (Healthcare coaching call)

Experimental

Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care.

干预措施: Questionnaire Administration (Other)

Arm III (Healthcare coaching call)

Experimental

Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care.

干预措施: Telephone-Based Intervention (Behavioral)

Arm IV (EXCELS website, health coaching calls)

Experimental

Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.

干预措施: Internet-Based Intervention (Other)

结局指标

主要结局

Use of preventive services

时间窗: Up to 18 months

Preventative services will be measured using adherence to evidence based guideline care which will be computed as a percentage of the eligible guideline related services provided to each patient.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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