Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03681405
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Neoplasm; Uterine Neoplasm	Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
• Actual Study Start Date: Dec 7, 2018
• Actual Primary Completion Date: Apr 9, 2020
• Actual Study Completion Date: Apr 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Informational Intervention; Given information about mindful movement and breathing; Other: Questionnaire Administration; Ancillary studies
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive caring attention phone call

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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)

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Stephanie Sohl, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 19, 2020
• Informed Consent Form - Sep 9, 2019

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03681405
• Other Study ID Numbers: IRB00052655; NCI-2018-01801; CCCWFU 97218; P30CA012197
• First Posted: Sep 24, 2018
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neoplasms; Ovarian Neoplasms; Uterine Neoplasms

Study Results

Participant Flow

Arm/Group Title	Group I eHealth Mindful Movement and Breathing (eMMB)	Group II Attention Control (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Period Title: Overall Study
STARTED	14	17
COMPLETED	13	17
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Group I (eMMB)	Group II (AC)	Total
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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 of all reporting groups
Overall Participants	13	17	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (13.0)	58.9 (10.1)	59.7 (11.2)
Sex: Female, Male (Count of Participants)
Female	13 100%	17 100%	30 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	13 100%	17 100%	30 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 5.9%	1 3.3%
White	13 100%	16 94.1%	29 96.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	17 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Retained in the Study
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	14	17
Number (95% Confidence Interval) [percentage of participants retained]	78.6 604.6%	82.4 484.7%

2. Primary Outcome

Title	Percentage of Participants That Were Adhered to the Intervention
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	14	17
Number (95% Confidence Interval) [percentage of participants adhered]	85.7 659.2%	70.6 415.3%

3. Secondary Outcome

Title	Change in Pain Intensity Per Patient Reported Outcomes Measurement Information System (PROMIS)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I eHealth Mindful Movement and Breathing (eMMB)	Group II Attention Control (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	3.63 (3.47)	3.11 (3.41)
2 weeks change in score	-1.9 (3.57)	-0.71 (2.67)
4 weeks change in score	-2.55 (3.08)	-1.14 (3.03)

4. Secondary Outcome

Title	Change in Affective Dimension of Pain
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	3.09 (3.53)	3.06 (3.75)
2 weeks change in score	-1.00 (3.89)	-0.71 (3.67)
4 weeks change in score	-2.00 (3.13)	-1.07 (2.92)

5. Secondary Outcome

Title	Change in Pain Interference Per PROMIS Measure
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	53.38 (11.22)	55.02 (10.93)
2 weeks change in score	-0.08 (13.88)	-0.93 (12.79)
4 weeks change in score	-5.92 (10.82)	-4.00 (12.27)

6. Secondary Outcome

Title	Change in Sleep Disturbances Per PROMIS Sleep Disturbance Short-form
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	49.65 (11.78)	52.46 (10.33)
2 weeks change in score	-3.42 (9.03)	-2.92 (8.26)
4 weeks change in score	-1.53 (8.15)	-1.90 (7.74)

7. Secondary Outcome

Title	Change in Psychological Distress Per PROMIS Depression
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	51.43 (11.07)	50.42 (8.51)
2 weeks score change	-7.38 (8.60)	-3.78 (9.98)
4 weeks score change	-6.58 (8.06)	-3.75 (5.47)

8. Secondary Outcome

Title	Change in Psychological Distress Per PROMIS Anxiety
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	17
Baseline	53.47 (12.29)	55.49 (8.40)
2 weeks change in score	-7.36 (7.83)	-9.66 (13.73)
4 weeks change in score	-5.86 (9.70)	-7.90 (11.64)

9. Secondary Outcome

Title	Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Description	Will describe any adverse events reported as frequencies.
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group I (eMMB)	Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies	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
Measure Participants	11	14
Number [number of adverse events]	0	0

Adverse Events

Time Frame	Four weeks
Arm/Group Title	Group I (eMMB)		Group II (AC)
Arm/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. Informational Intervention: Given information about mindful movement and breathing Questionnaire Administration: Ancillary studies		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
All Cause Mortality
	Group I (eMMB)		Group II (AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/17 (0%)
Serious Adverse Events
	Group I (eMMB)		Group II (AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Group I (eMMB)		Group II (AC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.