REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire
研究概览
简要总结
The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
详细描述
Primary Objective: To determine efficacy of eHealth Mindful Movement and Breathing (eMMB) as compared to Life Impact Reflection (LIR) for improving postoperative pain intensity 4-weeks postoperative in patients who received abdominal surgery for a suspected gynecologic malignancy.
Secondary Objectives:
- At week 2 and 3 months post-operative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain intensity in patients who received abdominal surgery for a suspected gynecologic malignancy.
- At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving affective pain in patients who received abdominal surgery for a suspected gynecologic malignancy.
- To determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving post-operative acute pain (pain intensity within 1 week post-surgery) in patients who received abdominal surgery for a suspected gynecologic malignancy.
- At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain interference in patients who received abdominal surgery for a suspected gynecologic malignancy.
- At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., depression) in patients who received abdominal surgery for a suspected gynecologic malignancy.
- At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., anxiety) in patients who received abdominal surgery for a suspected gynecologic malignancy.
- At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving sleep disturbances in patients who received abdominal surgery for a suspected gynecologic malignancy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Participants age 18 years and older at time of consent.
- •Scheduled for an abdominal gynecological surgery (i.e., uterine, ovarian) to remove a mass that is suspected to be malignant
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Able to understand, read and write English (since the intervention is conducted in English)
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Presence of a psychotic disorder, current suicidal ideation, or other unstable major psychiatric condition documented by diagnosis in the medical chart.
- •Unwillingness or inability to follow study procedures
研究组 & 干预措施
Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)
Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.
干预措施: eHealth Mindful Movement and Breathing (Other)
Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)
Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.
干预措施: PROMIS Questionnaires (Other)
Arm 2 Life Impacts Reflection Group (LIR)
The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.
干预措施: Life Impacts Reflection (Other)
Arm 2 Life Impacts Reflection Group (LIR)
The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.
干预措施: PROMIS Questionnaires (Other)
结局指标
主要结局
Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire
时间窗: 4 weeks postoperatively
Efficacy of the intervention will be evaluated by measuring pain intensity scores between the two groups from the Patient Reported Outcomes Measurement Information System (PROMIS) pain intensity item (How would you rate your pain on average?), which is validated for assessing pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Models will be adjusted for the three randomization stratification variables (study site, type of cancer, type of surgery). Linear contrasts will be used to estimate the difference between the two groups.
次要结局
- Anxiety- Short Form 4a Questionnaire(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)
- Change in Pain Interference(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)
- Change in Pain Intensity - PROMIS Pain Intensity Questionnaire(At 2 weeks and 3 months postoperatively)
- Change in Postoperative Acute Pain - PROMIS Questionnaire(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)
- Sleep Disturbance Short Form 4a Questionnaire(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)
- Change in Affective Pain - PROMIS Questionnaire(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)
- Emotional Distress-Depression - Short Form 4a Questionnaire(At baseline and 2 weeks, 4 weeks and 3 months postoperatively)