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

Wake Forest University (WFU)

Status: Completed

Conditions: Malignant Uterine Neoplasm; Malignant Female Reproductive System Neoplasm; Female Reproductive System Neoplasm; Suspicious for Malignancy; Uterine Neoplasm; Ovarian Neoplasm; Ovarian Carcinoma

Treatments: Procedure: Supportive Care; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03379376

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU 04517 (Other Identifier)

NCI-2018-00584 (Registry Identifier)

IRB00046462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Supportive Care (eMMB)

Experimental 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.

Treatment:

Other: Questionnaire Administration

Procedure: Supportive Care