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Completed

NCT Number: NCT03379376

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

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.

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Key information

Conditions

Female Reproductive System Neoplasm Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Malignant Female Reproductive System Neoplasm Malignant Uterine Neoplasm Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasm Ovarian Neoplasms Suspicious for Malignancy Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasm Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Receive questionnaire

Supportive Care

Procedure

Undergo eHealth mindful moving and breathing

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. Number of Participants Confident in the Use of EHealth Format

    Time frame: 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 outcomes

  1. Number of Participants Recruited and Completed All Assessments

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 4 weeks

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2017
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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