Enhancing Management of Patient Reported Outcomes With Emotion Regulation (EMPOWER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Accrual
研究概览
简要总结
This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on the health and well-being of young adults with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors.
II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability.
SECONDARY OBJECTIVES:
I. To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and understand English
- •Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
- •18 to 39 years of age at diagnosis
- •Within 0-5 years post-active treatment
- •Wireless internet connection or a home computer that is connected to the internet
排除标准
- •Evidence of a cancer recurrence
- •History of multiple primary cancers
- •Currently receiving palliative or hospice care
- •Significant psychiatric history
研究组 & 干预措施
Supportive Care
Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.
干预措施: Quality-of-Life Assessment (Procedure)
Supportive Care
Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.
干预措施: Internet-Based Intervention (Other)
Supportive Care
Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Accrual
时间窗: Up to 19 months
Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution.
Adherence - Number of Completed Exercises
时间窗: At 12 weeks
Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Acceptability - Mean Value
时间窗: At 12 weeks
Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Number of Patients Who Refused to Participate
时间窗: At 12 weeks
The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.
Number of Patient Provided Data at 8 Weeks - Retention
时间窗: At 8 week
Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site
Adherence - Proportion of Completed Interventions (Mean Value)
时间窗: At 12 weeks
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions.
Adherence - Proportion of Completed Interventions (Proportion Value)
时间窗: At 12 weeks
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions.
Number of Patients Provided Data at 12 Weeks - Retention
时间窗: At 12 weeks
Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Number of Website Visits
时间窗: At 12 weeks
Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Acceptability - Proportion Value
时间窗: At 12 weeks
Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
次要结局
未报告次要终点