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

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ClinicalTrials.gov Identifier: NCT03379376
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Female Reproductive System Neoplasm Malignant Female Reproductive System Neoplasm Malignant Uterine Neoplasm Ovarian Carcinoma Ovarian Neoplasm Suspicious for Malignancy Uterine Neoplasm Other: Questionnaire Administration Procedure: Supportive Care Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : April 5, 2018
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : November 2, 2018


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




Primary Outcome Measures :
  1. A refined manual for intervention implementation for the next phase of the study [ Time Frame: Up to 4 weeks ]
    To be determined by calculating 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with data. The qualitative and quantitative analyses will be evaluated in a mixed-methods framework for consistency and discrepancies to refine the protocol for future studies.


Secondary Outcome Measures :
  1. Recruitment [ Time Frame: Up to 4 weeks ]
    To be determined by tracking the number of screened participants, those who are eligible, and the percent who agree to participate. For those not meeting the eligibility criteria, reasons will be summarized. The proportion of participants and corresponding 95% confidence intervals (CI) for participants who participated in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.

  2. Adherence [ Time Frame: Up to 4 weeks ]
    To be determined by comparing participants who are non-adherent or who drop out by demographic characteristics, intervention group, and baseline scores of the measures.

  3. Assessment completion [ Time Frame: Up to 4 weeks ]
    To be determined by the proportion of participants and corresponding 95% CI for participants who participated in the eMMB sessions and those who completed all assessments will be computed; we will also calculate the percent of participants who complete the 4-week visit to assess retention.

  4. Incidence of adverse effects graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 [ Time Frame: Up to 4 weeks ]
    Adverse events will be categorized according to the likelihood that they are related to the study intervention. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.

  5. Retention rate [ Time Frame: Up to 4 weeks ]
    To be assessed by calculating the percent of participants who complete the 4-week visit. The proportion of participants and corresponding 95% CI for participants who participated in the eMMB sessions and those who completed all assessments will be computed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379376


Locations
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United States, North Carolina
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
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Principal Investigator: Stephanie Sohl Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03379376     History of Changes
Other Study ID Numbers: IRB00046462
NCI-2018-00584 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 04517 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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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:
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Ovarian Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases