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临床试验/NCT04713449
NCT04713449进行中(未招募)不适用

Enhancing Self Care Among Oral Cancer Survivors: The Empowered Survivor Trial

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 643 人开始时间: 2021年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
643
试验地点
1
主要终点
Self-efficacy score

研究概览

简要总结

Project's goal is evaluate an online tool the research team created called Empowered Survivor (ES) against a free online self-management intervention developed for cancer survivors by the National Cancer Institute and the American Cancer Society called Springboard Beyond Cancer.

详细描述

600 patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the New Jersey State Cancer Registry or the Cancer Registry of Greater California and randomly assigned to ES or Springboard Beyond Cancer. Participants will complete measures at baseline, 2, and 6-months post-baseline. The investigators will also complete a process evaluation of Empowered Survivor.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years;
  • Diagnosed with a first primary invasive oral or oropharyngeal cancer between 1 and 3 years ago;
  • Currently cancer free (but can have experienced a recurrence);
  • Has internet access;
  • Read English;
  • Has sufficient vision to read a survey and complete an online intervention

排除标准

  • 未提供

研究组 & 干预措施

Empowered Survivor online

Experimental

The online intervention, called Empowered Survivor (ES) is a self-management intervention for patients with head and neck cancer. The intervention contains the following modules: Introduction; Difficulty Swallowing and Muscle Strength; Oral Care; Long-term Follow-Up Care/Oral exams; Calm and Connect; and Maintaining.

干预措施: Empowered Survivor Online (Other)

Empowered Survivor online

Experimental

The online intervention, called Empowered Survivor (ES) is a self-management intervention for patients with head and neck cancer. The intervention contains the following modules: Introduction; Difficulty Swallowing and Muscle Strength; Oral Care; Long-term Follow-Up Care/Oral exams; Calm and Connect; and Maintaining.

干预措施: Survey Administration (Other)

Springboard Beyond Cancer

Active Comparator

Springboard Beyond Cancer is a general resource for survivors of all cancer. It is a free self-management program for cancer survivors developed by trusted sources, the ACS and the NCI.

干预措施: Springboard Beyond Cancer (Other)

Springboard Beyond Cancer

Active Comparator

Springboard Beyond Cancer is a general resource for survivors of all cancer. It is a free self-management program for cancer survivors developed by trusted sources, the ACS and the NCI.

干预措施: Survey Administration (Other)

结局指标

主要结局

Self-efficacy score

时间窗: Baseline, two and 6 months post-baseline

Change in self- efficacy measured with the Self-efficacy scale (22 items) which targets confidence in managing aspects of self-care (e.g., dry mouth, swallowing, oral self-exam, communicating with providers, emotions). Administered at multiple time points to measure effect of the intervention. Ratings range from 1 (not at all confident) to 5 (very confident). An item average will be calculated.

Preparedness for survivorship

时间窗: Baseline, two and 6 months post-baseline

Change in preparedness for survivorship. The Preparedness for survivorship scale (10 items) developed by the investigator assesses whether information received about survivorship was sufficient, helpful, comprehensive, and covered self-care tasks. Administered at multiple time points to measure effect of the intervention. Items are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher score indicate better preparedness.

Quality of Life score measured using the The European Organization for Research and Treatment of Cancer (EORTC)- Head and Neck

时间窗: Baseline, two and 6 months post-baseline

Change in QOL score over time. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43. The European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire- Head and Neck-43 is the updated version of the EORTC H\&N 35, used in the researcher's pilot work. The EORTC QLQ-HN is the most widely-used measure of Head and Neck QOL. The investigators use the total score in analyses, but will evaluate subscales. Administered at multiple time points to measure effect of the intervention. Items are rated on 1 (not at all)-4 (very much) Likert scale and higher scores indicate worse QOL.

次要结局

  • Performance of exercises to improve swallowing, past month (yes/no)(Baseline, two and 6 months post-baseline)
  • Comprehensiveness is the number of areas checked (11 areas) during the oral self-exam(Baseline, two and 6 months post-baseline)
  • Performance of head/neck exercises, past month (yes/no)(Baseline, two and 6 months post-baseline)
  • Performance of oral self-exam, past month(Baseline, two and 6 months post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Manne, PhD

Chief, Behavioral Sciences

Rutgers, The State University of New Jersey

研究点 (1)

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