EHealth Mindful Movement and Breathing in Improving Outcomes in Participants Undergoing Gynecologic Surgery

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03379376
Collaborator
National Cancer Institute (NCI) (NIH)
10
1
1
6.9
1.4

Study Details

Study Description

Brief Summary

This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery. Supportive therapy, such as eHealth mindful movement and breathing, uses techniques that include gentle movements, breathing, and relaxation techniques which may help participants cope with and improve their surgical experiences.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire Administration
  • Procedure: Supportive Care
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. To field-test implementation strategies of the mindful movement and breathing (eMMB) intervention that has been adapted to the eHealth Format.
OUTLINE:

Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.

After completion of study, participants are followed up at 4 weeks from surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II
Actual Study Start Date :
Apr 5, 2018
Actual Primary Completion Date :
Oct 15, 2018
Actual Study Completion Date :
Nov 2, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive Care (eMMB)

Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible.

Other: Questionnaire Administration
Receive questionnaire

Procedure: Supportive Care
Undergo eHealth mindful moving and breathing
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Confident in the Use of EHealth Format [Up to 4 weeks]

      This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.

    Secondary Outcome Measures

    1. Number of Participants Recruited and Completed All Assessments [Up to 4 weeks]

      Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.

    2. Number of Participants That Adhered to Study Interventions [Up to 4 weeks]

      To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:

    3. Number of Participants Reporting Adverse Events [Up to 4 weeks]

      Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.

    4. Percentage of Participants Completing 4-week Visits [Up to 4 weeks]

      To be assessed by calculating the percent of participants who complete the 4-week visit.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    • Cognitively able to complete assessments as judged by the study team

    • Able to understand, read and write English

    Exclusion Criteria:
    • Have schizophrenia or any other psychotic disorder

    • Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Stephanie Sohl, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03379376
    Other Study ID Numbers:
    • IRB00046462
    • NCI-2018-00584
    • CCCWFU 04517
    • P30CA012197
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 30, 2019
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Period Title: Overall Study
    STARTED 10
    COMPLETED 5
    NOT COMPLETED 5

    Baseline Characteristics

    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Overall Participants 10
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    58.2
    (14.4)
    Sex: Female, Male (Count of Participants)
    Female
    10
    100%
    Male
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    10
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    10%
    White
    8
    80%
    More than one race
    1
    10%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    10
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Confident in the Use of EHealth Format
    Description This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.
    Time Frame Up to 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Measure Participants 10
    Count of Participants [Participants]
    7
    70%
    2. Secondary Outcome
    Title Number of Participants Recruited and Completed All Assessments
    Description Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.
    Time Frame Up to 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Measure Participants 10
    Count of Participants [Participants]
    5
    50%
    3. Secondary Outcome
    Title Number of Participants That Adhered to Study Interventions
    Description To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:
    Time Frame Up to 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Measure Participants 10
    Count of Participants [Participants]
    7
    70%
    4. Secondary Outcome
    Title Number of Participants Reporting Adverse Events
    Description Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.
    Time Frame Up to 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Measure Participants 10
    Count of Participants [Participants]
    1
    10%
    5. Secondary Outcome
    Title Percentage of Participants Completing 4-week Visits
    Description To be assessed by calculating the percent of participants who complete the 4-week visit.
    Time Frame Up to 4 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    Measure Participants 10
    Count of Participants [Participants]
    5
    50%

    Adverse Events

    Time Frame Nonserious adverse events will be monitored on a quarterly basis and serious adverse events up to 4 weeks.
    Adverse Event Reporting Description
    Arm/Group Title Supportive Care (eMMB)
    Arm/Group Description Participants receive a self-directed 20-minute eMMB video and are instructed to practice eMMB at least once before surgery and daily for 2 weeks after surgery. Participants may also request additional guidance from a yoga instructor via telephone and video conference before surgery and again 1 day after surgery or as soon as feasible. Questionnaire Administration: Receive questionnaire Supportive Care: Undergo eHealth mindful moving and breathing
    All Cause Mortality
    Supportive Care (eMMB)
    Affected / at Risk (%) # Events
    Total 1/10 (10%)
    Serious Adverse Events
    Supportive Care (eMMB)
    Affected / at Risk (%) # Events
    Total 1/10 (10%)
    Infections and infestations
    Sepsis 1/10 (10%) 1
    Other (Not Including Serious) Adverse Events
    Supportive Care (eMMB)
    Affected / at Risk (%) # Events
    Total 0/10 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Meg O'Mara - Study Coordinator
    Organization Wake Forest University Health Sciences
    Phone 336-716-5440
    Email megreen@wakehealth.edu
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03379376
    Other Study ID Numbers:
    • IRB00046462
    • NCI-2018-00584
    • CCCWFU 04517
    • P30CA012197
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 30, 2019
    Last Verified:
    Dec 1, 2019