Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Ovarian Neoplasm Clinical Trial

Official title:

Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681405
• Other study ID #: IRB00052655
• Secondary ID: NCI-2018-01801CC
• Status: Completed
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: April 9, 2020

Study information

• Verified date: November 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 9, 2020
• Est. primary completion date: April 9, 2020
• 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 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.

Related Conditions & MeSH terms

• Neoplasms
• Ovarian Neoplasm
• Ovarian Neoplasms
• Uterine Neoplasm
• Uterine Neoplasms

Intervention

Other:
• Informational Intervention
Given information about mindful movement and breathing
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive caring attention phone call

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	Percentage of Participants Retained in the Study	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.	Up to 2 weeks
Primary	Percentage of Participants That Were Adhered to the Intervention	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.	Up to 5 weeks
Secondary	Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)	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)	Baseline, 2 weeks and 4 weeks
Secondary	Change in Affective Dimension of Pain	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.	Baseline, 2 weeks and 4 weeks
Secondary	Change in Pain Interference Per PROMIS Measure	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.	Baseline, 2 weeks and 4 weeks
Secondary	Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form	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.	Baseline, 2 weeks and 4 weeks
Secondary	Change in Psychological Distress Per PROMIS Depression	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.	Baseline, 2 weeks and 4 weeks
Secondary	Change in Psychological Distress Per PROMIS Anxiety	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.	Baseline, 2 weeks and 4 weeks
Secondary	Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	Will describe any adverse events reported as frequencies.	Up to 4 weeks