Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
NCT ID: NCT03681405
Last Updated: 2021-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2018-12-07
2020-04-09
Brief Summary
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Detailed Description
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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.
GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.
GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group I (eMMB)
Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.
Informational Intervention
Given information about mindful movement and breathing
Questionnaire Administration
Ancillary studies
Group II (AC)
Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive caring attention phone call
Interventions
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Informational Intervention
Given information about mindful movement and breathing
Questionnaire Administration
Ancillary studies
Telephone-Based Intervention
Receive caring attention phone call
Eligibility Criteria
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Inclusion Criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1.
* Cognitively able to complete assessments as judged by the study team.
* Able to understand, read and write English.
Exclusion Criteria
* Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Stephanie Sohl
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Sohl SJ, Strahley AE, Tooze JA, Levine BJ, Kelly MG, Wheeler A, Evans S, Danhauer SC. Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes. J Psychosoc Oncol. 2024;42(2):223-241. doi: 10.1080/07347332.2023.2236083. Epub 2023 Jul 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2018-01801
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 97218
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00052655
Identifier Type: -
Identifier Source: org_study_id