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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 98422 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| R01CA266995 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB) | Experimental | 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. |
|
| Arm 2 Life Impacts Reflection Group (LIR) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth Mindful Movement and Breathing | Other | The self-directed intervention includes an approximately 20-minute eMMB will teach synergistic components: (a) Mindful Meditation - 2 minutes of observing the current state of the body, emotions, thoughts, energy, and breath. Mindful attention may facilitate safe physical movements; (b) Mindful Movement - 10 minutes of gentle movements coordinated with and intended to enhance the breath; (c) Breathing and Relaxation - 3 minutes of placing the hands above the navel (rather than on the belly to avoid discomfort) and noticing them rise and fall with a focus on slightly extending the exhale, which will prepare participants for meditation); (d) Meditation - 5 minutes of observing the natural breath without reacting to it. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire | 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. | 4 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity - PROMIS Pain Intensity Questionnaire | Efficacy of the intervention in measuring pain intensity scores 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. |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie J Sohl, PhD | Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health - Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States | ||
| Wake Forest Baptist Comprehensive Cancer Center |
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| Life Impacts Reflection | Other | This self-directed intervention will focus on active listening, reflection of statements, and avoiding negative judgments. Participants will write brief diary entries daily for four weeks postoperatively and as they choose thereafter. Participants will be given the option of completing diaries on the tablet computer or paper. The instructions for daily diary entries will be, "What were some of the events or circumstances that affected you in the past day? Think back over the past day and write down on the lines below up to five events that had an impact on you." A study team member will call participants to encourage diary completion two days (Postop Day 3) and two weeks after the synchronous session. |
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| PROMIS Questionnaires | Other | Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression) |
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| At 2 weeks and 3 months postoperatively |
| Change in Affective Pain - PROMIS Questionnaire | Efficacy of the intervention in affective pain will be assessed with one item (numeric rating scale) on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). 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. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Change in Postoperative Acute Pain - PROMIS Questionnaire | Efficacy of the intervention in post-operative acute pain is defined as pain experienced daily over the first week after surgery and will be measured daily using the 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. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Change in Pain Interference | Efficacy of the intervention in improving pain interference 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. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Emotional Distress-Depression - Short Form 4a Questionnaire | Efficacy of the intervention in improving psychological distress symptoms 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. Scoring scale: 0 - never to 5 - always. The higher the score the greater the depression. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Anxiety- Short Form 4a Questionnaire | Efficacy of the intervention in improving psychological distress symptoms 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. Scoring scale: 0 - never to 5 - always. The higher the score the greater the anxiety. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Sleep Disturbance Short Form 4a Questionnaire | Efficacy of the intervention in improving sleep disturbances 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. Likert scoring scale: 5 - very poor to 1 - very good or reversed with 5 - not at all to 1 - very much. | At baseline and 2 weeks, 4 weeks and 3 months postoperatively |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012119 | Respiration |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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