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临床试验/NCT04594096
NCT04594096已完成不适用

Improving Treatment-Related Symptom Management in Adolescents and Young Adults

University of California, Davis1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月30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
20
试验地点
1
主要终点
Proportion of Patients Completing the Trial

研究概览

简要总结

This study will test the acceptability and feasibility of a telehealth intervention to improve communication between patients and medical providers in adolescent and young adult (AYA) cancer patients receiving chemotherapy treatment.

研究设计

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

入排标准

年龄范围
12 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with cancer undergoing active treatment and who have received at least two cycles of chemotherapy
  • •Access to Epic MyChart (we will facilitate access to MyChart for interested patients who are not yet signed up)
  • •Access to a smartphone or tablet to access EPIC MyChart telehealth appointments

排除标准

  • •Non-English or non-Spanish speaking patients
  • •Potentially completing therapy during study period (including follow-up period) or plans to leave UCDCCC during study period

研究组 & 干预措施

Immediate Intervention Arm

Experimental

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the immediate arm will start the intervention (telehealth visits) in Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will resume clinical care as usual.

干预措施: Telehealth visits (Behavioral)

Immediate Intervention Arm

Experimental

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the immediate arm will start the intervention (telehealth visits) in Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will resume clinical care as usual.

干预措施: Standard of Care (Behavioral)

Delayed Intervention Arm

Experimental

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the delayed arm will receive clinical care as usual during Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will start the intervention (telehealth visits).

干预措施: Telehealth visits (Behavioral)

Delayed Intervention Arm

Experimental

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the delayed arm will receive clinical care as usual during Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will start the intervention (telehealth visits).

干预措施: Standard of Care (Behavioral)

结局指标

主要结局

Proportion of Patients Completing the Trial

时间窗: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)

\>65% of enrolled patients will complete the trial

次要结局

  • Survey Response Rate(end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days))
  • Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)(end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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