NCT04604158已完成不适用
IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients
Gillian Gresham2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
研究概览
简要总结
This is a single-arm, prospective, interventional study in cancer survivors and patients to examine the feasibility of a mobile health application, Elly (Elly Health Inc.), to reduce levels of anxiety, stress, loneliness, and social isolation. Participants will be given access to the Elly phone application developed by Elly Health Inc. and will be asked to complete questionnaires measuring quality of life at multiple timepoints during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer of any type and currently receiving cancer-targeted treatment or have received cancer-targeted treatment within 6 months of consent date based on self-report. Cancer-targeted treatment includes chemotherapy, radiation therapy, hormonal therapy, biologic therapy, immunotherapy, and surgery.
- •18 years or older
- •Access to and ability to use an iPhone (SE+, iOS 12.4+)
- •Ability to understand and read English
- •Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
排除标准
- •Hearing loss or vision impairment that would preclude the participant from accessing and using the app (use of hearing aids or visual aids is acceptable) based on self-report.
结局指标
主要结局
Absolute change in patient-reported anxiety scores at Day 30 compared with baseline.
时间窗: 30 days
Absolute change in patient-reported anxiety scores as measures using the NIH (National Institutes of Health) PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire at Day 30 compared with baseline. The minimum value is 6 and maximum value is 30, and a lower score means a better outcome.
次要结局
- Absolute change in patient-reported anxiety scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported anxiety scores at Day 14 compared with baseline.(14 days)
- Absolute change in patient-reported anxiety scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported depression scores at Day 30 compared with baseline.(30 days)
- Absolute change in patient-reported depression scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported loneliness scores at Day 30 compared with baseline.(30 days)
- Absolute change in patient-reported anxiety scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported anxiety scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported depression scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported loneliness scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported social isolation scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported social isolation scores at Day 180 compared with baseline.(180 days)
- Participant's experience with Elly app at Day 180-360.(Day 360)
- Absolute change in patient-reported anxiety scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported depression scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported depression scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported loneliness scores at Day 150 compared with baseline.(150 days)
- Absolute change in patient-reported social isolation scores at Day 60 compared with baseline.(60 days)
- Feasibility(180 days)
- Participant's experience with Elly app at Day 14-30.(Day 30)
- Absolute change in patient-reported depression scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported loneliness scores at Day 60 compared with baseline.(60 days)
- Absolute change in patient-reported loneliness scores at Day 90 compared with baseline.(90 days)
- Absolute change in patient-reported loneliness scores at Day 180 compared with baseline.(180 days)
- Absolute change in patient-reported social isolation scores at Day 120 compared with baseline.(120 days)
- Absolute change in patient-reported social isolation scores at Day 150 compared with baseline.(150 days)
- Elly app login amount (frequency and duration)(180 days)
- Absolute change in patient-reported social isolation scores at Day 30 compared with baseline.(30 days)
- Frequency of Elly app use(180 days)
研究者
Gillian Gresham
Principal Investigator
Cedars-Sinai Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's LymphomaQuality of LifeLymphomaNCT00098566Fred Hutchinson Cancer Center36
已完成
不适用
Hemi-Ablative Prostate BrachytherapyCancer of the ProstateProstatic NeoplasmsNCT02632669Royal Surrey County Hospital NHS Foundation Trust31
进行中（未招募）
2 期
Anti-PD1-antibody and Pulsed HHI for Advanced BCCBasal Cell CarcinomaNCT04679480Reinhard Dummer20
Unknown
2 期
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic CancerChemotherapy EffectPancreatic CancerNCT04581876Fudan University120
终止
4 期
A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the DiseaseMetastatic Prostate CancerNCT01933022Astellas Pharma Europe Ltd.1