Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percentage of Participants Retained in the Study
研究概览
简要总结
This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.
详细描述
PRIMARY OBJECTIVES:
I. To calculate recruitment, adherence, assessment completion, and retention rates.
SECONDARY OBJECTIVES:
I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.
OUTLINE: Participants are randomized to 1 of 2 groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a suspected malignancy.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of =<
- •Cognitively able to complete assessments as judged by the study team.
- •Able to understand, read and write English.
排除标准
- •Have schizophrenia or any other psychotic disorder.
- •Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.
结局指标
主要结局
Percentage of Participants Retained in the Study
时间窗: Up to 2 weeks
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.
Percentage of Participants That Were Adhered to the Intervention
时间窗: Up to 5 weeks
Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% CI for participants who participated in each group will be computed.
次要结局
- Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(Up to 4 weeks)
- Change in Psychological Distress Per PROMIS Depression(Baseline, 2 weeks and 4 weeks)
- Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)(Baseline, 2 weeks and 4 weeks)
- Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form(Baseline, 2 weeks and 4 weeks)
- Change in Affective Dimension of Pain(Baseline, 2 weeks and 4 weeks)
- Change in Psychological Distress Per PROMIS Anxiety(Baseline, 2 weeks and 4 weeks)
- Change in Pain Interference Per PROMIS Measure(Baseline, 2 weeks and 4 weeks)