Trial Outcomes & Findings for Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery (NCT NCT03681405)

NCT ID: NCT03681405

Last Updated: 2021-11-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Up to 2 weeks
• Results posted on: 2021-11-08

Participant Flow

Participant milestones

Measure	Group I eHealth 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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Overall Study STARTED	14	17
Overall Study COMPLETED	13	17
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Group I eHealth 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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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. Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive caring attention phone call
Overall Study Found to be ineligible after randomized	1	0

Baseline Characteristics

Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

Baseline characteristics by cohort

Measure	Group I (eMMB) n=13 Participants 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	Group II (AC) n=17 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 13.0 • n=5 Participants	58.9 years STANDARD_DEVIATION 10.1 • n=7 Participants	59.7 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=14 Participants 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	Group II (AC) n=17 Participants 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
Percentage of Participants Retained in the Study	78.6 percentage of participants retained Interval 49.2 to 95.4	82.4 percentage of participants retained Interval 56.6 to 96.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=14 Participants 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	Group II (AC) n=17 Participants 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
Percentage of Participants That Were Adhered to the Intervention	85.7 percentage of participants adhered Interval 57.2 to 98.2	70.6 percentage of participants adhered Interval 44.1 to 89.7

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS) Baseline	3.63 score on a scale Standard Deviation 3.47	3.11 score on a scale Standard Deviation 3.41
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS) 2 weeks change in score	-1.9 score on a scale Standard Deviation 3.57	-0.71 score on a scale Standard Deviation 2.67
Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS) 4 weeks change in score	-2.55 score on a scale Standard Deviation 3.08	-1.14 score on a scale Standard Deviation 3.03

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Affective Dimension of Pain Baseline	3.09 score on a scale Standard Deviation 3.53	3.06 score on a scale Standard Deviation 3.75
Change in Affective Dimension of Pain 2 weeks change in score	-1.00 score on a scale Standard Deviation 3.89	-0.71 score on a scale Standard Deviation 3.67
Change in Affective Dimension of Pain 4 weeks change in score	-2.00 score on a scale Standard Deviation 3.13	-1.07 score on a scale Standard Deviation 2.92

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Pain Interference Per PROMIS Measure Baseline	53.38 score on a scale Standard Deviation 11.22	55.02 score on a scale Standard Deviation 10.93
Change in Pain Interference Per PROMIS Measure 2 weeks change in score	-0.08 score on a scale Standard Deviation 13.88	-0.93 score on a scale Standard Deviation 12.79
Change in Pain Interference Per PROMIS Measure 4 weeks change in score	-5.92 score on a scale Standard Deviation 10.82	-4.00 score on a scale Standard Deviation 12.27

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form Baseline	49.65 score on a scale Standard Deviation 11.78	52.46 score on a scale Standard Deviation 10.33
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form 2 weeks change in score	-3.42 score on a scale Standard Deviation 9.03	-2.92 score on a scale Standard Deviation 8.26
Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form 4 weeks change in score	-1.53 score on a scale Standard Deviation 8.15	-1.90 score on a scale Standard Deviation 7.74

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Psychological Distress Per PROMIS Depression Baseline	51.43 score on a scale Standard Deviation 11.07	50.42 score on a scale Standard Deviation 8.51
Change in Psychological Distress Per PROMIS Depression 2 weeks score change	-7.38 score on a scale Standard Deviation 8.60	-3.78 score on a scale Standard Deviation 9.98
Change in Psychological Distress Per PROMIS Depression 4 weeks score change	-6.58 score on a scale Standard Deviation 8.06	-3.75 score on a scale Standard Deviation 5.47

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=17 Participants 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
Change in Psychological Distress Per PROMIS Anxiety Baseline	53.47 score on a scale Standard Deviation 12.29	55.49 score on a scale Standard Deviation 8.40
Change in Psychological Distress Per PROMIS Anxiety 2 weeks change in score	-7.36 score on a scale Standard Deviation 7.83	-9.66 score on a scale Standard Deviation 13.73
Change in Psychological Distress Per PROMIS Anxiety 4 weeks change in score	-5.86 score on a scale Standard Deviation 9.70	-7.90 score on a scale Standard Deviation 11.64

SECONDARY outcome

Timeframe: Up to 4 weeks

Will describe any adverse events reported as frequencies.

Outcome measures

Measure	Group I (eMMB) n=11 Participants 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	Group II (AC) n=14 Participants 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
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	0 number of adverse events	0 number of adverse events

Adverse Events

Group I (eMMB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II (AC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meg O'Mara

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-716-9055

Email: megreen@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place