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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:
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:
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.
Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.
Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-based Guided Mindfulness | Experimental | A 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress. |
|
| Video-based Guided Expressive Writing | Experimental | 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. |
|
| Non-Mindfulness Based Therapeutic Approaches | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Intervention | Behavioral | Guided meditation or guided expressive writing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability of delivering video based mindfulness interventions | 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. | From enrollment to 6 months post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-reported Global Impression of Change | Patient global impression for change will be assessed using the PCIG (Rampakakis, Ste-Marie, et al. 2015, Perrot and Lantéri-Minet 2019) questionnaire. The questionnaire includes two items in which patients rate the change in their activity limitations, symptoms, and emotions on a descriptive scale from "No Change" = 1 to "A great deal better" = 7 and a visual scale from "Much better" = 0 to "Much worse" = 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Ward, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36141374 | Background | Wang R, Li L, Xu J, Ding ZT, Qiao J, Redding SR, Xianyu YY, Ouyang YQ. Effects of Structured Expressive Writing on Quality of Life and Perceived Self-Care Self-Efficacy of Breast Cancer Patients Undergoing Chemotherapy in Central China: A Randomized Controlled Trial. Healthcare (Basel). 2022 Sep 14;10(9):1762. doi: 10.3390/healthcare10091762. | |
| 30605517 |
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| Non-mindfulness Intervention | Behavioral | 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. |
|
| From enrollment to 6 months post-enrollment. |
| Participant-reported pain intensity | Change in pain symptoms will be assessed using the PROMIS Scale v2.0 Pain Intensity 3a questionnaire. This measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported pain interference | Change in pain interference will be assessed using the PROMIS Scale v1.1 Pain Interference 4a questionnaire. This measure includes three items rating the scale in which pain interferes with daily life from "Not at all" = 1 to "Very much" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported physical function | Change in physical will be assessed using the PROMIS Scale v2.0 Physical Function Short Form 6b questionnaire. This measure includes six items rating difficulty of daily tasks related to physical function from "Without any difficulty" = 1 to "Unable to do" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported health engagement | Participant health engagement will be assessed using the PHE questionnaire (Graffigna et. al 2015). This measure includes nine items in which patients rate how they feel about and engage with their disease. This scale has been adapted for study use to be rated on a scale from "never" = 1 to "always" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported depression | Change in emotional distress symptoms for depression will be assessed using the PROMIS Scale v1.0 Emotional Distress-Depression Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different depression related emotions from "Never" = 1 to "Always" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported anxiety | Change in emotional distress symptoms for anxiety will be assessed using the PROMIS Scale v1.0 Emotional Distress-Anxiety Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different anxiety related emotions from "Never" = 1 to "Always" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported social isolation | Change in levels of social isolation will be assessed using the PROMIS Scale v2.0 Social Isolation Short form 4a questionnaire. The questionnaire includes four items rating the occurrence of different feelings regarding social isolation from "Never" = 1 to "Always" = 5. | From enrollment to 6 months post-enrollment. |
| Participant-reported quality of life | Participant quality of life will be assessed using the World Health Organization Quality of Life questionnaire. This questionnaire consists of two items that assess how patients feel about their quality of life on a scale from "Very poor" and "Very dissatisfied" =1 to "Very good" and "Very satisfied" = 5. | From enrollment to 6 months post-enrollment. |
| Participant use of pain medicine | Patient narcotic consumption in the post-operative period will be collected via chart abstraction. Use of pain medicine will be compared with intervention acceptability and frequency of use at the end of the study, which may help guide future studies. | From enrollment to 6 months post-enrollment. |
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