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

Ovarian Carcinoma Clinical Trial

Official title:

EHealth Mindful Movement and Breathing to Improve Gynecologic Cancer Surgery Outcomes: Aim II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379376
• Other study ID #: IRB00046462
• Secondary ID: NCI-2018-00584CC
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: December 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Reproductive System Neoplasm
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Malignant Uterine Neoplasm
• Neoplasms
• Ovarian Carcinoma
• Ovarian Neoplasm
• Ovarian Neoplasms
• Suspicious for Malignancy
• Uterine Neoplasm
• Uterine Neoplasms

Intervention

Other:
• Questionnaire Administration
Receive questionnaire

Procedure:
• Supportive Care
Undergo eHealth mindful moving and breathing

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Confident in the Use of EHealth Format	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.	Up to 4 weeks
Secondary	Number of Participants Recruited and Completed All Assessments	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.	Up to 4 weeks
Secondary	Number of Participants That Adhered to Study Interventions	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:	Up to 4 weeks
Secondary	Number of Participants Reporting Adverse Events	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.	Up to 4 weeks
Secondary	Percentage of Participants Completing 4-week Visits	To be assessed by calculating the percent of participants who complete the 4-week visit.	Up to 4 weeks