Structured Post-Operative Pain and Distress Treatment Intervention for Patients Undergoing Surgery for Intra-Abdominal Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of delivering video based mindfulness interventions
研究概览
简要总结
The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer.
The main questions this study aims to answer are:
- Is it possible to use video-based coping strategies to help manage pain and distress after surgery?
- Is one type of coping strategy better than another?
Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.
Participants will:
- Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.
- Fill out some questionnaires before surgery, which should take 10-15 minutes.
- Be assigned to one of three coping strategies.
- Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.
- Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.
- Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.
详细描述
We propose to conduct a quality improvement project to determine the impact of different types of psychosocial support for patients undergoing surgery for intrabdominal malignancies.
This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.
Objectives:
Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.
Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •English-speaking males or females 18 or older within the University of Utah Hospital system being treated for an intrabdominal malignancy.
- •Patients undergoing surgical treatment of cancer within the abdominal cavity.
排除标准
- •Altered mental status due to delirium or pharmacological sedation as determined by a clinical assessment conducted by a study staff.
- •Non-English speaking.
研究组 & 干预措施
Video-based Guided Mindfulness
A 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress.
干预措施: Mindfulness Intervention (Behavioral)
Video-based Guided Expressive Writing
A 15-20-minute video based on expressive writing prompts aimed at addressing pain and distress. If the patient is assigned expressive writing, they will be offered a blank journal to use for the expressive writing interventions after randomization.
干预措施: Mindfulness Intervention (Behavioral)
Non-Mindfulness Based Therapeutic Approaches
Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested.
干预措施: Non-mindfulness Intervention (Behavioral)
结局指标
主要结局
Feasibility and acceptability of delivering video based mindfulness interventions
时间窗: From enrollment to 6 months post-enrollment.
The frequency that patients start and complete at least one mindfulness intervention will be evaluated and compared to the other two cohorts. The frequency of engaging with and completing the interventions will be reported descriptively. The Chi2 for Fisher's will be used for exact test.
次要结局
- Participant-reported Global Impression of Change(From enrollment to 6 months post-enrollment.)
- Participant-reported pain intensity(From enrollment to 6 months post-enrollment.)
- Participant-reported pain interference(From enrollment to 6 months post-enrollment.)
- Participant-reported physical function(From enrollment to 6 months post-enrollment.)
- Participant-reported health engagement(From enrollment to 6 months post-enrollment.)
- Participant-reported depression(From enrollment to 6 months post-enrollment.)
- Participant-reported anxiety(From enrollment to 6 months post-enrollment.)
- Participant-reported social isolation(From enrollment to 6 months post-enrollment.)
- Participant-reported quality of life(From enrollment to 6 months post-enrollment.)
- Participant use of pain medicine(From enrollment to 6 months post-enrollment.)