Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Wake Forest University (WFU)

Status: Completed

Conditions: Uterine Neoplasm; Ovarian Neoplasm

Treatments: Other: Informational Intervention; Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03681405

IRB00052655

CCCWFU 97218 (Other Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2018-01801 (Registry Identifier)

Details and patient eligibility

About

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

Full description

PRIMARY OBJECTIVES:

I. To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (MINDFUL MOVEMENT AND BREATHING [eMMB]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL [AC]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Enrollment: 31 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 suspected malignancy.
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

Group I (eMMB)

Experimental group

Description:

Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Group II (AC)

Active Comparator group

Description:

Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Treatment:

Other: Questionnaire Administration

Behavioral: Telephone-Based Intervention