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Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03681405
Enrollment
31
Registered
2018-09-24
Start date
2018-12-07
Completion date
2020-04-09
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasm, Uterine Neoplasm

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.

Interventions

OTHERInformational Intervention

Given information about mindful movement and breathing

OTHERQuestionnaire Administration

Ancillary studies

BEHAVIORALTelephone-Based Intervention

Receive caring attention phone call

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Retained in the StudyUp to 2 weeksWill 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 InterventionUp to 5 weeksWill 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

MeasureTime frameDescription
Change in Pain Interference Per PROMIS MeasureBaseline, 2 weeks and 4 weeksBaseline 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.
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-formBaseline, 2 weeks and 4 weeksBaseline 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 Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)Baseline, 2 weeks and 4 weeksBaseline 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 Psychological Distress Per PROMIS AnxietyBaseline, 2 weeks and 4 weeksBaseline 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.
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0Up to 4 weeksWill describe any adverse events reported as frequencies.
Change in Psychological Distress Per PROMIS DepressionBaseline, 2 weeks and 4 weeksBaseline 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 Affective Dimension of PainBaseline, 2 weeks and 4 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Group I (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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies
13
Group II (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. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
17
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyFound to be ineligible after randomized10

Baseline characteristics

CharacteristicGroup II (AC)TotalGroup I (eMMB)
Age, Continuous58.9 years
STANDARD_DEVIATION 10.1
59.7 years
STANDARD_DEVIATION 11.2
60.6 years
STANDARD_DEVIATION 13
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants30 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants29 Participants13 Participants
Region of Enrollment
United States
17 participants30 participants13 participants
Sex: Female, Male
Female
17 Participants30 Participants13 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 17
other
Total, other adverse events
0 / 130 / 17
serious
Total, serious adverse events
0 / 130 / 17

Outcome results

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.

Time frame: Up to 2 weeks

Population: Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of retention to be analyzed for the study.

ArmMeasureValue (NUMBER)
Group I (eMMB)Percentage of Participants Retained in the Study78.6 percentage of participants retained
Group II (AC)Percentage of Participants Retained in the Study82.4 percentage of participants retained
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.

Time frame: Up to 5 weeks

Population: Of the 14 randomized to intervention for Group I, 1 person was removed from the study following randomization (and prior to filling out any surveys at baseline) due to ineligibility. For Group I and II, not all participants completed requirements of adherence to be analyzed for the study.

ArmMeasureValue (NUMBER)
Group I (eMMB)Percentage of Participants That Were Adhered to the Intervention85.7 percentage of participants adhered
Group II (AC)Percentage of Participants That Were Adhered to the Intervention70.6 percentage of participants adhered
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.

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Affective Dimension of PainBaseline3.09 score on a scaleStandard Deviation 3.53
Group I (eMMB)Change in Affective Dimension of Pain2 weeks change in score-1.00 score on a scaleStandard Deviation 3.89
Group I (eMMB)Change in Affective Dimension of Pain4 weeks change in score-2.00 score on a scaleStandard Deviation 3.13
Group II (AC)Change in Affective Dimension of PainBaseline3.06 score on a scaleStandard Deviation 3.75
Group II (AC)Change in Affective Dimension of Pain2 weeks change in score-0.71 score on a scaleStandard Deviation 3.67
Group II (AC)Change in Affective Dimension of Pain4 weeks change in score-1.07 score on a scaleStandard Deviation 2.92
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)

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)Baseline3.63 score on a scaleStandard Deviation 3.47
Group I (eMMB)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)2 weeks change in score-1.9 score on a scaleStandard Deviation 3.57
Group I (eMMB)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)4 weeks change in score-2.55 score on a scaleStandard Deviation 3.08
Group II (AC)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)Baseline3.11 score on a scaleStandard Deviation 3.41
Group II (AC)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)2 weeks change in score-0.71 score on a scaleStandard Deviation 2.67
Group II (AC)Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)4 weeks change in score-1.14 score on a scaleStandard Deviation 3.03
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.

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Pain Interference Per PROMIS MeasureBaseline53.38 score on a scaleStandard Deviation 11.22
Group I (eMMB)Change in Pain Interference Per PROMIS Measure2 weeks change in score-0.08 score on a scaleStandard Deviation 13.88
Group I (eMMB)Change in Pain Interference Per PROMIS Measure4 weeks change in score-5.92 score on a scaleStandard Deviation 10.82
Group II (AC)Change in Pain Interference Per PROMIS MeasureBaseline55.02 score on a scaleStandard Deviation 10.93
Group II (AC)Change in Pain Interference Per PROMIS Measure2 weeks change in score-0.93 score on a scaleStandard Deviation 12.79
Group II (AC)Change in Pain Interference Per PROMIS Measure4 weeks change in score-4.00 score on a scaleStandard Deviation 12.27
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.

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Psychological Distress Per PROMIS AnxietyBaseline53.47 score on a scaleStandard Deviation 12.29
Group I (eMMB)Change in Psychological Distress Per PROMIS Anxiety2 weeks change in score-7.36 score on a scaleStandard Deviation 7.83
Group I (eMMB)Change in Psychological Distress Per PROMIS Anxiety4 weeks change in score-5.86 score on a scaleStandard Deviation 9.7
Group II (AC)Change in Psychological Distress Per PROMIS AnxietyBaseline55.49 score on a scaleStandard Deviation 8.4
Group II (AC)Change in Psychological Distress Per PROMIS Anxiety2 weeks change in score-9.66 score on a scaleStandard Deviation 13.73
Group II (AC)Change in Psychological Distress Per PROMIS Anxiety4 weeks change in score-7.90 score on a scaleStandard Deviation 11.64
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.

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Psychological Distress Per PROMIS DepressionBaseline51.43 score on a scaleStandard Deviation 11.07
Group I (eMMB)Change in Psychological Distress Per PROMIS Depression2 weeks score change-7.38 score on a scaleStandard Deviation 8.6
Group I (eMMB)Change in Psychological Distress Per PROMIS Depression4 weeks score change-6.58 score on a scaleStandard Deviation 8.06
Group II (AC)Change in Psychological Distress Per PROMIS DepressionBaseline50.42 score on a scaleStandard Deviation 8.51
Group II (AC)Change in Psychological Distress Per PROMIS Depression2 weeks score change-3.78 score on a scaleStandard Deviation 9.98
Group II (AC)Change in Psychological Distress Per PROMIS Depression4 weeks score change-3.75 score on a scaleStandard Deviation 5.47
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.

Time frame: Baseline, 2 weeks and 4 weeks

Population: Investigators discovered recently that there had been a protocol deviation such that a participant had had their surgery PRIOR to filling out the baseline survey. That participant's baseline data had to be removed from our analyses and revised data has been submitted. Not all participants provided evaluable data for analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group I (eMMB)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-formBaseline49.65 score on a scaleStandard Deviation 11.78
Group I (eMMB)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form2 weeks change in score-3.42 score on a scaleStandard Deviation 9.03
Group I (eMMB)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form4 weeks change in score-1.53 score on a scaleStandard Deviation 8.15
Group II (AC)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-formBaseline52.46 score on a scaleStandard Deviation 10.33
Group II (AC)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form2 weeks change in score-2.92 score on a scaleStandard Deviation 8.26
Group II (AC)Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form4 weeks change in score-1.90 score on a scaleStandard Deviation 7.74
Secondary

Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Will describe any adverse events reported as frequencies.

Time frame: Up to 4 weeks

ArmMeasureValue (NUMBER)
Group I (eMMB)Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.00 number of adverse events
Group II (AC)Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.00 number of adverse events

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026