Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Not Applicable

Completed

• Conditions: Ovarian Neoplasm; Uterine Neoplasm
• Interventions: Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

• Registration Number: NCT03681405
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-24
• Study Start: 2018-12-07
• Primary Completion: 2020-04-09
• Study Completion: 2020-04-09
• Results First Submitted: 2021-05-06
• Results First Submitted QC: 2021-06-02
• Results First Posted: 2021-06-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (eMMB)	Questionnaire Administration	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 (AC)	Questionnaire Administration	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.
Group I (eMMB)	Informational Intervention	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 (AC)	Telephone-Based Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Retained in the Study	Up to 2 weeks	Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track 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% CI for participants who participated in each group will be computed. Will use one-sample tests of binomial proportions to compare the recruitment, adherence, and retention rates to the hypothesized values of 50%, 70% and 70%, respectively.
Percentage of Participants That Were Adhered to the Intervention	Up to 5 weeks	Will provide quantitative data to guide future study planning. Will calculate 95% confidence intervals for each of the feasibility measures to determine the range of estimates that are consistent with the data. Will track 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% CI for participants who participated in each group will be computed.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Up to 4 weeks	Will describe any adverse events reported as frequencies.
Change in Psychological Distress Per PROMIS Depression	Baseline, 2 weeks and 4 weeks	Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with the higher score representing greater depression in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)	Baseline, 2 weeks and 4 weeks	Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. A change in pain intensity between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.; The PROMIS assesses pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain)
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form	Baseline, 2 weeks and 4 weeks	Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with higher scores representing a greater sleep disturbance for participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Change in Affective Dimension of Pain	Baseline, 2 weeks and 4 weeks	The affective dimension of pain will be assessed with one item on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). A higher score represent a higher affective dimension of pain for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Change in Psychological Distress Per PROMIS Anxiety	Baseline, 2 weeks and 4 weeks	Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Score range is 0-100 with a higher score presenting a greater level of anxiety in the participants. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.
Change in Pain Interference Per PROMIS Measure	Baseline, 2 weeks and 4 weeks	Baseline analyses will include descriptive statistics of pain, background characteristics and other possible confounding variables by intervention group. The primary goal of the statistical analysis of these measures for this Aim will be to estimate standard deviations (SD) for use in future studies. Additional analyses will include fitting mixed analysis of covariance (ANCOVA) models (adjustment for baseline) to model the trajectory of pain by time and group accounting for the repeated measures on a subject. Score range is 0-100 with a higher score representing greater pain interference for the participant. A change in score between two or more time points (baseline, 2 weeks and 4 weeks) will be reported.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States