Support for Optimal Recovery Following Gynecologic Surgery Study (SOARING)
Phase: NA
Conditions: Ovarian Neoplasm, Uterine Neoplasm
Sponsor: Wake Forest University Health Sciences

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CCCWFU 97218: Support for Optimal Recovery following 
Gynecologic Surgery Study (SOARING) 
Study Chairman or Principal Investigator:   
Stephanie Jean Sohl, Ph.D. 
Assistant Professor 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
 
NCT03681405  
Supported by:  
The National Center for Complementary and Integrative Health  
 
 
  
 

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Tool Revision History 
Version Number: 2.0 
Version Date: 9/26/2018 
Summary of Revisions Made: Added minor changes to Baseline Assessments section to reflect 
other document changes 
Version Number: 3.0 
Version Date: 11/19/2018 
Summary of Revisions Made: Changed protocol to send daily survey 8 days post intervention to 
ensure data completeness for those reporting information from the prior day 
Version Number: 4.0 
Version Date: 8/23/2019 
Summary of Revisions Made: Added option for electronic consent via REDCap; removed 
incorrect description of post operative assessment on page 24 
Version Number: 5.0 
Version Date: 8/19/2020 
Summary of Revisions Made: Changed target accrual from N=44 to N=31.  

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TABLE OF CONTENTS 
Page 
Title Page ....................................................................................................................................... 1 
Tool Revision History ................................................................................................................. 2 
TABLE OF CONTENTS ............................................................................................................. 3 
STUDY TEAM ROSTER........................................................................................................... 6 
PRÉCIS ....................................................................................................................................... 8 
1. STUDY OBJECTIVES ........................................................................................................... 10 
1.1 
Primary Objective ......................................................................................................... 10 
1.2 
Secondary Objectives.................................................................................................... 10 
2. BACKGROUND AND RATIONALE .................................................................................. 10 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 10 
2.2 
Study Rationale ............................................................................................................. 14 
3. STUDY DESIGN ..................................................................................................................... 16 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 17 
4.1 
Inclusion Criteria .......................................................................................................... 17 
4.2 
Exclusion Criteria ......................................................................................................... 18 
4.3 
Study Enrollment Procedures ....................................................................................... 18 
5. STUDY INTERVENTIONS .................................................................................................. 19 
5.1 
Interventions, Administration, and Duration ................................................................ 19 
5.2 
Handling of Study Interventions ................................................................................... 21 
5.3 
Concomitant Interventions ............................................................................................ 21 
5.3.1 Allowed Interventions ............................................................................................... 21 
5.3.2 Required Interventions .............................................................................................. 22 
5.3.3 Prohibited Interventions ............................................................................................ 22 
5.4 
Adherence Assessment ................................................................................................. 22 
6. STUDY PROCEDURES ........................................................................................................ 23 
6.1 
Schedule of Evaluations ................................................................................................ 23 
6.2 
Description of Evaluations ............................................................................................ 24 
6.2.1 Screening Evaluation ................................................................................................ 24 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 25 

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6.2.3 Blinding..................................................................................................................... 27 
6.2.4 Follow-up Visits........................................................................................................ 27 
6.2.5 Completion/Final Evaluation .................................................................................... 28 
7. SAFETY ASSESSMENTS ..................................................................................................... 29 
7.1 
Specification of Safety Parameters ............................................................................... 29 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 29 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 30 
7.4 
Reporting Procedures .................................................................................................... 30 
7.5 
Followup for Adverse Events ....................................................................................... 31 
7.6 
Safety Monitoring ......................................................................................................... 31 
8. INTERVENTION DISCONTINUATION ........................................................................... 32 
9. STATISTICAL CONSIDERATIONS .................................................................................. 32 
9.1 
General Design Issues ................................................................................................... 32 
9.2 
Sample Size and Randomization .................................................................................. 33 
Treatment Assignment Procedures ....................................................................................... 34 
9.3  
Definition of Populations .............................................................................................. 34 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 34 
9.5 
Outcomes ...................................................................................................................... 35 
9.5.1 Primary Outcome ...................................................................................................... 35 
9.5.2 Secondary Outcomes ................................................................................................ 35 
9.6 
Data Analyses ............................................................................................................... 35 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 36 
10.1 
Data Collection Forms .................................................................................................. 36 
10.2 
Data Management ......................................................................................................... 37 
10.3 
Quality Assurance ......................................................................................................... 37 
10.3.1 
Training ................................................................................................................. 37 
10.3.2 
Quality Control Committee................................................................................... 37 
10.3.3 
Metrics .................................................................................................................. 38 
10.3.4 
Protocol Deviations ............................................................................................... 38 
10.3.5 
Monitoring ............................................................................................................ 39 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 39 
11.1 
Institutional Review Board (IRB) Review .................................................................... 39 
11.2 
Informed Consent Forms .............................................................................................. 39 
11.3 
Participant Confidentiality ............................................................................................ 39 

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11.4 
Study Discontinuation ................................................................................................... 39 
12. COMMITTEES..................................................................................................................... 40 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 40 
14. REFERENCES ...................................................................................................................... 40 
15. SUPPLEMENTS/APPENDICES ........................................................................................ 47 
 

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STUDY TEAM ROSTER  
Stephanie Jean Sohl, PhD, Principal Investigator (PI) 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
Michael Kelly, MD, Co-Investigator 
Department of Obstetrics and Gynecology 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
 
Janet Tooze, PhD, Co-Investigator 
Department of Biostatistical Sciences 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
 
Suzanne Danhauer, PhD, Co-Investigator 
Department of Social Sciences and Health Policy 
Division of Public Health Sciences 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
Fadel Zeidan, PhD, Co-Investigator 
Department of Neurobiology and Anatomy 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 
 
 
Umit Topaloglu, PhD., Co-Investigator 
Department of Cancer Biology 
Wake Forest School of Medicine 
Medical Center Boulevard 
Winston-Salem, NC 27157-1063 

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PRÉCIS  
Study Title  
Support for Optimal Recovery following Gynecologic Surgery Study 
(SOARING) 
 
Objectives  
The overall aims of the study are to determine feasibility, any adverse events, 
variability of proposed outcomes, and acceptability of the Mindful Movement and 
Breathing (eMMB) and Attention Control (AC) interventions that have been adapted 
to the eHealth Format. To accomplish these aims, we will conduct a pilot randomized 
controlled trial of the eMMB compared to AC among 31 women undergoing surgery 
for a suspected gynecologic malignancy. More specifically, we will: 
(1) Calculate recruitment, adherence, assessment completion, and retention rates; 
(2) Document the frequency of adverse events;  
(3) Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, 
psychological distress) for the next phase of study; and 
 (3) Qualitatively assess acceptability to guide future study planning.  
Design and Outcomes   
We propose a prospective stratified randomized controlled pilot study investigating 
the feasibility of comparing the eMMB to AC for improving pain, sleep disturbances, 
and psychological stress. Participants enrolled (N=31) will be randomized 1:1: to 
eMMB  or AC. Allocation will be stratified by cancer type (i.e. ovarian, uterine) and 
invasiveness of the planned surgical procedure type (i.e., laparotomy or robotic). 
Patient-reported assessments will be conducted at four time points: before surgery 
(baseline), one day after surgery, two weeks after surgery and 4 weeks after surgery. 
Participants will also be asked to complete daily assessments of outcomes and 
adherence to home practice of the intervention and wear a wrist actigraphy device for 
one week before and one week following surgery. In addition, medical records will be 
reviewed, treatment fidelity observed, and an interview conducted at a follow-up 
clinic visit or by telephone. We will also track recruitment, adherence to the 
videoconference intervention, any other contact with interventionists, adverse events, 
and completion of assessments. Those who decline participation or drop out of the 
study will be asked for feedback about their choices. Our findings will inform an 
efficacy trial of the eMMB for improving surgical outcomes of adults who undergo 
surgery for a suspected gynecologic malignancy.   
Interventions and Duration  
In-person MMB and AC interventions investigated in our Preliminary Research have 
been adapted to be implemented by eHealth. The initial dose of the eMMB and AC 
interventions will include a call to invite participants to initiate additional guidance 
upon request prior to surgery and a meeting with the participantby 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 in the eMMB group 

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and diaries to complete daily in the AC group.  
The approximately 20-minute eMMB will teach: (a) Awareness Meditation - noticing 
the current state of the body, emotions, thoughts, energy, and breath; (b) Movement –
gentle movements coordinated with the breath; (c) Breathing and Relaxation - placing 
the hands above the navel and noticing them rise and fall with a focus on slightly 
extending the exhale; (d) Awareness Meditation – 5 minutes of awareness of noticing 
the natural breath without changing it to enhance mindfulness. The intention to 
maintain attention or mindfulness (sthira), comfort and ease (sukha) is highlighted 
throughout the eMMB.  
An AC group focused on providing caring attention will be employed to account for 
the added time, attention, interaction with an interventionist, and efficacy 
expectations of the eMMB. In addition, the interventionist will ask patients to write 
brief diary entries daily at home as used in previous research and our current study. 
The AC will be implemented by an individual with experience working in a medical 
setting who will be trained to create and maintain a relationship by using techniques 
such as active listening, reflection of statements, and avoiding negative judgments. 
Sample Size and Population  
The target population of the proposed research is adult women scheduled to undergo 
surgery for a suspected gynecologic malignancy at the Wake Forest Baptist 
Comprehensive Cancer Center (WFBCCC). We will enroll 31 participants, who will 
be eligible regardless of race, ethnicity, or national origin.  
 
 

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1. STUDY OBJECTIVES 
1.1 
Primary Objective 
The overall aims of the study are to determine feasibility, any adverse events, 
variability of proposed outcomes and acceptability of the Mindful Movement and 
Breathing (eMMB) and Attention Control (AC) interventions that have been adapted 
to the eHealth Format. To accomplish these aims, we will conduct a pilot randomized 
controlled trial to of the eMMB compared to AC among 31 women undergoing 
surgery for a suspected gynecologic malignancy. More specifically, the primary 
feasibility objective is to: 
(1) Calculate recruitment, adherence, assessment completion, and retention rates; 
Hypothesis: We hypothesize that we will enroll at least 50% of eligible patients, 
participants will adhere to 70% of the interventions, and at least 70% of 
participants will complete study assessments and be retained in the study.   
An adequate retention rate at week 2 (future primary outcome assessment time 
point) will be our primary indicator that this study was successful. 
1.2 Secondary Objectives 
(2) Document the frequency of adverse events;  
(3) Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, 
psychological distress) for the next phase of study; and 
(4) Qualitatively assess acceptability to guide future study planning. Refining study 
methodology will result in a Manual of Operations and Procedures for an efficacy 
trial.   
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Improved management of acute perioperative pain and co-morbid symptoms 
may proactively reach an at-risk population and reduce the burden of chronic 
pain. Over 80,000 women diagnosed with gynecologic cancers each year regularly 
face major abdominal surgery.1 Most (64%) experience considerable pain,2 yet 
management of postoperative pain is still inadequate.3 For example, less than half of 
patients who underwent surgery for cancer felt their postsurgical pain was relieved by 
50% (on scale from 0-100%).9 In addition, many of these women also report 
postoperative sleep disturbances (39-70%),2,4 and psychological distress (20%),2,5 
both associated with pain.2,6–8 There are likely bidirectional relationships among pain, 
sleep disturbances and psychological distress.4 Such acute postoperative symptoms 
are important to address, because they predict persistent symptoms4,9,10 and a reduced 
quality of life.11,12 Therefore, interventions to simultaneously improve perioperative 
pain, sleep disturbances, and psychological distress are needed to impact immediate 
and longer-term outcomes including preventing the transition of acute to chronic 
pain.13  

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Predictors of chronic pain include the efficacy of initial pain treatment.14 
Furthermore, those who are women, have surgery and are diagnosed with cancer are 
most vulnerable to chronic pain.13 Even post-treatment, the prevalence of chronic 
pain is estimated to be up to 40% among post-treatment cancer survivors15 and 
women with cancer report more severe pain than do men.16 Due to the increasing 
numbers of patients surviving cancer for longer periods of time, pain management is a 
chronic problem with guidelines for treatment similar to treatment of chronic pain in 
the general population.17 These guidelines recommend use of multimodal therapies 
with a stated preference for nonpharmacologic therapy (including mind-body 
techniques such as mindfulness and relaxation) and nonopioid pharmacologic 
therapy.14,18 However, the level of evidence for use of such modalities is only 
moderate.14,19 Additional fully-powered randomized controlled trials of 
nonpharmacological interventions compared to active control groups are needed. 
Similarly, adverse effects of long-term opioid use and potential abuse among cancer 
survivors contributes to the concern of the larger national opioid epidemic.17,20,21 
Indeed, one study reported that 29% of cancer patients were at high risk for opioid 
misuse21 and women respond differently to pain medication such that they use more 
postsurgical opioid medication and may be more susceptible to addiction.13,22 Thus, 
preventing the transition of acute to chronic pain and reducing related opioid use in 
the proposed high risk population would have a substantial public health impact.13,20 
 
Yoga is a multimodal intervention that may optimally address pain and co-
morbid symptoms. Clinical guidelines for postoperative pain management 
recommend including nonpharmacological interventions and pain medication since 
they may have an additive effect on pain relief.19 Pain has sensory (e.g., location, 
physical characteristics) and affective dimensions (e.g., unpleasantness, appraisal of 
consequences); interventions to alleviate both may be more effective than those that 
address only the sensory aspects of pain.23,24 Mind-body interventions, are commonly 
sought after nonpharmacological approaches for addressing pain, sleep disturbances, 
and psychological stress, particularly in cancer patients.13,25,26 Specifically, yoga is 
gaining popularity,27 and there is a generally positive impression of and curiosity 
about yoga.28 Yoga is a promising intervention to simultaneously improve such 
aspects of pain, and associated symptoms (i.e., sleep disturbances, psychological 
distress). The key elements of yoga are movements, breathing exercises, and 
meditation.29 Empirical evidence supports the efficacy of yoga as an intervention for 
reducing pain,30–32 sleep disturbances,33 and psychological distress,34,35 in a variety of 
populations36 and in studies specific to cancer survivors.37–39 There is some evidences 
for the benefit of yoga in a surgical context. In one study, yoga taught to women 
undergoing surgery for suspected breast cancer reduced length of hospital stay and 
improved wound healing.40 These results support the possible efficacy of yoga for 
reducing postoperative complications. However, that study did not assess the effect of 
yoga on pain. Overall, evidence supporting the efficacy of yoga for psychological 
distress is strong when implemented as group classes for women with breast cancer 
and less certain regarding the efficacy for sleep disturbances and pain. The evidence 
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with breast cancer or studies of yoga for low back pain.30,41 There are limited studies 
investigating the efficacy of yoga for other cancer types or perioperatively. 
 
Yoga has a potential advantage over other perioperative interventions (i.e., relaxation, 
hypnosis)32,42 because it has multiple components that also support the goals of usual 
care (e.g., to encourage early postoperative ambulation and deep breathing via 
incentive spirometry) and thus may help treat other surgical comlications.43–45 Usual 
care to manage pain includes teaching patients to splint the abdomen by holding a 
pillow to it before coughing or deep breaths, allowing them to perform these 
functions with less pain and monitoring pain every four hours on a scale from 0-10 
(10 for the worst pain) to ensure that adequate pain medication is given. Early 
postoperative ambulation aims to reduce postoperative ileus (bowel obstruction) and 
deep venous thrombosis (blood clots). Deep breathing via incentive spirometry 
encourages patients to clear the lungs of fluid to prevent pneumonia. About 30% of 
women undergoing surgery for a suspected gynecologic malignancy have a surgical 
complication (e.g., postoperative ileus, deep venous thrombosis, pneumonia);46,47 
these contribute substantially to costs.8,46 Research supports that yoga breathing 
practices improve lung function36,48 and yoga movements increase mobility (i.e., 
balance and flexibility).36 Further, combining awareness with movement is a method 
of promoting meditation that may be easier for some people to experience than 
methods that are taught while still.49 Thus, adding yoga to usual care may be helpful 
for postsurgical pain in a number of ways. 
 
Proposed mechanisms of effects of yoga on pain and co-morbid symptoms. A 
Self-Regulation Framework50,51 proposes both psychological (e.g., mindfulness, self-
efficacy) and physiological (e.g., relaxation, ambulation, deep breathing) explanations 
for the positive influence of yoga, which primarily affects psychological and physical 
well-being through reducing the stress response. One component of the Self-
Regulation Framework proposes that cognitive appraisals such as self-efficacy for 
managing pain30,52,53 could explain the proposed impact of learning self-regulation 
skills (i.e., yoga) on pain. A recent study also suggested that mind-body interventions 
likely address pain through a mechanism different than opioid medication, potentially 
providing a self-regulation strategy that works with medication in an additive fashion 
to improve pain management.54 Thus, mind-body interventions may further enhance 
pain control for those taking medications, and potentially reduce the risk of 
postoperative chronic pain and possible opioid addiction by empowering patients to 
use other pain-reducing strategies. The conceptual framework highlighting constructs 
considered in the current study informed by this prior work is presented in Figure 
1.50,51,54  

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Implementation of yoga as a self-directed eHealth intervention may increase 
adherence and aid dissemination, which will lead to a greater public health 
impact. A growing body of literatures supports the idea that behavioral skills can be 
taught through information technology (eHealth).55 However, few eHealth 
interventions have been quantitatively evaluated specifically for people with cancer; 
thus their efficacy for cancer patients is unclear.56,57 To improve upon limitations of 
current research, future studies should incorporate clinically meaningful validated 
measures and utilize a conceptual framework to improve methodological rigor. 
Implementing behavioral interventions via eHealth could address the unmet 
psychosocial needs of cancer patients in a way that reduces costs and thus could have 
public health impact.56 EHealth addresses barriers to participation such as 
accessibility (e.g., one treatment can be utilized by many people simultaneously), 
travel distance, and dissemination (e.g., increased treatment fidelity).56  
 
Some research supports that adherence to treatment offered through behavioral 
internet interventions (e.g., for improving depression, physical activity) is as good as 
adherence to face-to face interventions.58,59 However, eHealth interventions have 
different levels of human interaction from exclusively self-directed to requiring 
considerable content guidance from a human provider.56 The Supportive 
Accountability60 model provides a framework for assessing how supportive 
interactions may influence intervention adherence. This theory posits that interaction 
factors, such as accountability, bond, and legitimacy, can potentially influence 
adherence to internet interventions with bond being the most important when the 
treatment focus is on providing skills training.60 In addition, the Supportive 
Accountability model suggests that the influence of these interaction factors on 
adherence may be moderated by motivation and communication “bandwidth” (i.e., 
the number of communication cues a medium can convey). Although some suppose 
that as the bandwidth lessens, the quality of interaction factors lessens, this is not 
always so, people can effectively communicate through various media. Thus, the 
optimal level of content guidance and communication medium to implement 
behavioral interventions is yet to be determined.56,60 

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2.2 
Study Rationale 
The proposed Mindful Movement and Breathing (eMMB) intervention adapts 
key elements of a longer intervention (about 10 weeks61) to a shorter format. 
Yoga implemented as traditional (often longer) group classes has demonstrated 
efficacy for reducing pain,31,38 sleep disturbances,33 and psychological distress.34,35,61 
Other researchers, and our team have shown that interventions to reduce pain, sleep 
disturbances and psychological distress such as cognitive-behavioral therapy, 
Mindfulness-based Stress Reduction (Co-I Zeidan), and yoga (PI: Sohl) can be 
successfully adapted to be brief.62–65 Such interventions can provide more immediate 
benefit and thus enhance participation and adherence. In fact, beneficial 
psychological and physiological effects were found after 15-minutes of yoga in 
healthy adults, with data suggesting more sustained improvement in respiration rate in 
the yoga group vs. meditation.49 The eMMB teaches essential aspects of yoga from 
the same tradition as implemented with other cancer survivors by Dr. Danhauer (Co-
Investigator)61 in a manner that may be easily adapted to other perioperative and 
cancer populations. This approach aims to design an intervention with promise for 
future dissemination.66 
 
The proposed Mindful Movement and Breathing (eMMB) intervention is 
implemented perioperatively. Although other yoga studies have been implemented 
in clinical settings, these studies either did not exclusively evaluate yoga67 or the yoga 
interventions were not brief.40,68 The eMMB is designed to improve upon previous 
interventions with its brevity and its adaptation to the acute needs of patients 
undergoing surgery for cancer. In addition, the eMMB will potentially contribute to a 
shift in the paradigm of yoga, which has been typically implemented in the United 
States as a complementary medicine modality (a separate practice used together with 
usual care), to become a component of integrative medicine (incorporated into usual 
care in a coordinated way).69  
 
Interest in perioperative yoga (PI: Sohl, Co-I’s: Danhauer & Tooze). To 
investigate patient interest in our proposed study, we surveyed 9 women who were in-
hospital before or after surgery for suspected gynecologic malignancy.70  Of 20 
women approached, 10 (mean age = 51 years; 89% White) agreed to complete the 
survey. Reasons that women declined participation included: not interested (n=8); 
non-cancer related health issues (n=1); other (n=1); plus one screen failure. 
Participants indicated on a scale from 1 (not useful) to 10 (useful) that they expected 
that the described “Yoga Skills Training” (YST) would be useful for reducing pain 
(M=6.7; SD=2.5) and distress (M=6.9; SD=2.0). They also provided feedback on the 
intervention name including that the word ‘yoga’ might deter some potential 
participants. The average length of time women reported being willing to participate 
in a YST session was 23 minutes. All participants indicated that they would be 
interested in learning the YST on their own and video was the most popular format 
selected for independent practice (n=4), followed by CD (n=2), written material (n=1) 
and other (n=2). Thus, the proposed intervention is called “Mindful Movement and 
Breathing” and will primarily be implemented via a 20-minute video.  

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Perioperative yoga feasibility (PI: Sohl, Co-I’s: Danhauer & Tooze). “Mindful 
Movement and Breathing (MMB)” describes the gentle physical activity in this 
intervention compared to other types of yoga. The MMB was designed for patients 
receiving chemotherapy71 and 
then tested in this non-
randomized trial to determine 
feasibility of the MMB (three 
20-minute in person sessions) 
among women undergoing an exploratory laparotomy for a suspected gynecologic 
malignancy (60% ovarian; 20% uterine; 20% cervical).65 Type of surgery was the 
primary reason for exclusion (86%) since we did not include less invasive surgeries 
(e.g., robotic). Of 18 eligible women approached, 10 (age M = 54.7 years; 90% 
White) enrolled in the study (55% recruitment). Seven women were retained in the 
study and no adverse events were reported. Only five women received the MMB pre-
operatively due to scheduling challenges. Participants completed two Visual 
Analogue Scale items of pain and distress immediately before and after each MMB 
(average session = 20.6 minutes). Pain and distress decreased with moderate to large 
effects (Table 1). On a scale from 1 (not at all) to 5 (very much) patients liked the 
MMB (M = 4.29, SD = 0.76), found it helpful (M = 3.71, SD = 0.95), and planned to 
continue to use what they learned (M = 3.71, SD = 1.11). These data support 
feasibility of testing the MMB in these patients, but revealed challenges to consistent 
implementation of the in-person MMB before surgery. Therefore, the proposed 
intervention will utilize an eHealth approach to test whether adherence would be 
greater. In addition, the proposed study will also include women scheduled for less 
invasive types of gynecologic cancer surgeries, which have become more common 
and may have more room for improvement in pain management.    
 
Strategies for disseminating yoga (PI: Danhauer). Two other prior pilot studies of 
gentle yoga for women with cancer conducted by our team demonstrated that group 
yoga classes reduced fatigue, depressive symptoms, and sleep disturbances.61,72 We 
next conducted a 3-site feasibility study through the Wake Forest NCI Community 
Oncology Research Program (NCORP) Research Base of women undergoing 
chemotherapy treatment for breast cancer (N=40) to investigate the feasibility of 
more broadly implementing this promising intervention (Co-I: Sohl). The primary 
difficulty was the need for specially trained teachers at each site.73 We then piloted 
yoga classes using videoconferencing, which allowed participants (N=5) to take part 
in study classes from a convenient location and two-way interaction with instructors 
and other participants. Twelve, 75-minute cancer-adapted Integral Yoga classes were 
offered twice weekly during the 6-week course of radiation therapy. Participants 
suggested that simplifying the technology would have increased their participation or 
otherwise improved their experience; however, participants did like the staying at 
home for the interventions. Participants also wanted more variety in the schedule and 
shorter classes. The proposed research will utilize videoconferencing only when 
participants have assistance from research staff. Home practice sessions will be 
shorter (20-minutes) and implemented via simpler technology. Future directions for 
Table 1. Pilot Results of MMB Before and After Surgery  
 
Before 
(n=5) 
Day 1 After 
(n=7) 
Day 2 After 
(n=7) 
Pain  
d = -0.67 
d = -0.76 
d = -0.95 
Distress 
d = -0.76 
d = -0.66 
d = -1.08 

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the proposed research will employ Dr. Danhauer’s experience with NCORP 
(U10CA081851).  
 
Efficacy of a brief mind-body intervention for reducing pain (PI: Zeidan). A brief 
mindfulness meditation intervention (four 20-minute training sessions) was 
significantly more effective at reducing pain than two well-validated placebo 
interventions (placebo cream, sham mindfulness mediation).74 Yet, all had 
significantly reduced pain intensity and unpleasantness ratings compared to the 
control group (reading). Sham mindfulness meditation (participants trained to take 
deep breaths and led to believe they were practicing mindfulness) was associated with 
greater reductions in respiration rate, demonstrating a mechanistic difference between 
sham and mindfulness meditation. Mindfulness meditation–related pain relief was 
associated with greater psychological executive-level modulation of pain and, in 
contrast, sham mindfulness meditation–induced analgesia was driven by 
physiological processes consistent with placebo and relaxation. Similar instructions 
for nonjudgmental attention to the breath, and instructions for taking deep breaths to 
slow breathing, will be incorporated into the eMMB to optimize the influence of the 
intervention on pain reduction. 
3. STUDY DESIGN  
The proposed research will determine feasibility and acceptability of investigating the 
eMMB and AC interventions to reduce pain and other surgical outcomes through an 
exploratory stratified randomized controlled pilot study among 31 women undergoing 
surgery for suspected gynecologic malignancies.  
Participants enrolled will be randomized 1:1 to eMMB or AC. Allocation will stratified 
by cancer type (i.e., ovarian or uterine) and invasiveness of the planned surgical 
procedure type (i.e., laparotomy or robotic). Patient-reported assessments will be 
conducted at four time points: before surgery (baseline), one day after surgery, two 
weeks after surgery and 4 weeks after surgery. Participants will also be asked to 
complete daily assessments of outcomes and adherence to home practice of the 
intervention and wear a wrist actigraphy device for up to one week before and one 
week following surgery. In addition, medical records will be reviewed, treatment 
fidelity observed, and an interview conducted at a follow-up clinic visit or by 
telephone. We will also track recruitment, adherence to the videoconference 
intervention, any other contact with interventionists, and completion of assessments. 
Our findings will inform an efficacy trial of the eMMB for improving surgical 
outcomes of adults who undergo surgery for a suspected gynecologic malignancy. 
 
In-person MMB and AC interventions investigated in our Preliminary Research will be 
adapted in the proposed research to be implemented by eHealth. The initial dose of the 
eMMB and AC interventions will include a call to invite participants to initiate 
additional guidance upon request prior to surgery and a meeting with the participant via 
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 in 
the eMMB group and diaries to complete daily in the AC group.  

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The approximately 20-minute eMMB will teach: (a) Awareness Meditation - noticing 
the current state of the body, emotions, thoughts, energy, and breath; (b) Movement –
gentle movements coordinated with the breath; (c) Breathing and Relaxation - placing 
the hands above the navel and noticing them rise and fall with a focus on slightly 
extending the exhale; (d) Awareness Meditation – 5 minutes of awareness of noticing 
the natural breath without changing it to enhance mindfulness. The intention to 
maintain attention or mindfulness (sthira), comfort and ease (sukha) is highlighted 
throughout the eMMB.  
 
An AC group focused on providing caring attention will be employed to account for 
the added time, attention, interaction with an interventionist, and efficacy expectations 
of the eMMB. In addition, the interventionist will ask patients to write brief diary 
entries daily at home as used in previous research and our current study. The AC will 
be implemented by an individual with experience working in a medical setting who 
will be trained to create and maintain a relationship by using techniques such as active 
listening, reflection of statements, and avoiding negative judgments. 
 
The total length of time each participant will be on study is approximately 4 weeks. 
The enrollment period for the trial is expected to continue for 12 months.  
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
We will seek approval from the Institutional Review Board (IRB) prior to 
implementing the proposed study and take precautions to ensure adequate protection 
of human subjects. Recruitment of women scheduled to undergo surgery for a 
suspected gynecologic malignancy at the Wake Forest Baptist Comprehensive Cancer 
Center (WFBCCC) will be facilitated by Dr. Kelly (Co-Investigator). To increase 
homogeneity, only the most prevalent gynecologic malignancies will be recruited (i.e. 
uterine, ovarian) that occur in only women. We chose this target population because 
adult women undergoing surgery for suspected cancer are at particularly high risk for 
experiencing chronic pain.13 In addition, this sample reduces variability due to sex 
differences in pain tolerance75 and response to pain medication.13 There are multiple 
theories that may explain these differences. Of particular note is the “vulnerability 
theory”, which posits that sex hormones affect the nervous system’s and 
psychological responses to pain.13  
4.1 
Inclusion Criteria 
 
 
Participants must meet all of the inclusion criteria to participate in this study.  
• Adult females (≥18 years of age)  
• 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. 
 

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4.2 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria listed below at baseline will 
be excluded from study participation: 
 
• 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. 
 
 
 
4.3 
Study Enrollment Procedures  
Individuals scheduled to undergo surgery for suspected gynecologic malignancies 
(i.e., uterine, ovarian) will be recruited from the Wake Forest Baptist Comprehensive 
Cancer Center (WFBCCC). To identify potential patients, the Project Manager will 
screen appointment lists and communicate with attending physicians regarding 
patients’ potential eligibility for the trial. Subject recruitment will be documented in a 
Screening Log including reasons for ineligibility, eligible patients approached, 
number who declined participation, and number successfully recruited. 
 
If the patient is interested and referred by the physician, the Project Manager will 
approach or call interested patients prior to surgery to explain the protocol, answer 
questions, determine eligibility, and discuss informed consent. After making sure the 
patient clearly understands the study procedures and agrees to follow them, the 
patient will be asked to sign the informed consent form electronically or in person. If 
signed electronically, patients will be asked to send the form back to us by a secure 
means (e.g., REDCap). In the case that the patient is consented electronically, either a 
hard copy or email attachment of the informed consent document will be provided to 
the participant. (Appendix A: Informed Consent Document). The original copy will 
be kept in the participant’s file. Each participant will be asked to separately agree to 
be audio recorded for the study, which will not affect their ability to participate. If 
they do consent to be videotaped, they are told in the consent form that they can ask 
not to be included in the filming or withdraw their consent to be videotaped at any 
time. These videos are focused on the interventionist for the sole purpose of 
increasing treatment fidelity. 
 
Eligible participants enrolled in the study will be randomized after baseline 
assessments to the eMMB or AC prior to surgery. 
 
Randomization. Participants enrolled will be randomized 1:1 to eMMB or AC.  
Allocation will be computer-generated, stratified by cancer type (i.e. ovarian, 
uterine), and concealed by Dr. Tooze (Biostatistician). Study team members will not 
know group assignment when enrolling participants. The Project Manager and PI who 
assign participants to interventions will be made aware of group assignment after a 
participant has provided informed consent. The Clinical Studies Staff member who 
will collect primary outcome data will be blinded to group assignment. Participants 
will be informed that they could be randomly assigned to 1 of 2 different supportive 
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gentle movement, writing, and/or relaxation strategies) and will be asked not to 
discuss study procedures with their treating surgeon, medical staff, or research 
personnel. Thus, participants and healthcare providers will also be blinded to 
randomization. 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
Active Intervention. The Mindful Movement and Breathing (eMMB) intervention 
will be administered individually via telephone and video conference for initial 
guidance and is primarily intended to be self-directed (video). We considered the 
style, delivery, components of the intervention, specific class sequences, facilitation 
of home practice, dose, dealing with modifications, selection of instructors, and 
measurement of intervention fidelity, as recommended in the development of a yoga 
intervention for a randomized trial.76  
Style. The content of the eMMB was informed by the PI’s training from the 
Integral Yoga Academy’s Yoga for People with Cancer Teacher Training and Urban 
Zen Integrative Therapy training, and was refined for this study by consulting with 
expert yoga therapists from the Krishnamacharya tradition (led by Dr. Wheeler, 
Consultant) and an expert in instructing mindfulness for reducing pain (Dr. Zeidan, 
Co-Investigator). Expert yoga therapists from the Krishnamacharya tradition are ideal 
for informing this approach since this tradition systematically selects yoga practices 
based on therapeutic targets (e.g., pain) and places an emphasis on daily home 
practice.77,78 Furthermore, the eMMB aims to promote mindfulness and relaxation.  
Delivery components and class sequence. The approximately 20-minute eMMB 
will teach: (a) Awareness Meditation - 2 minutes of noticing the current state of the 
body, emotions, thoughts, energy, and breath. Brief meditation has been shown to be 
effective for decreasing pain,79 sleep disturbance80 and psychological distress81 and 
will increase mindfulness to facilitate safe physical movements; (b) Movement – 10 
minutes of gentle movements coordinated with the breath also aim to enhance 
mindfulness to reduce pain, facilitate bowel movement (to prevent ileus) and blood 
flow (to prevent deep venous thrombosis); (c) Breathing and Relaxation - 3 minutes 
of placing the hands above the navel (rather than on the belly to avoid discomfort) 
and noticing them rise and fall with a focus on slightly extending the exhale to induce 
relaxation. This practice aims to improve lung capacity (to reduce pulmonary 
compromise) and reduce pain, sleep disturbance and psychological distress; (d) 
Awareness Meditation – 5 minutes of awareness of noticing the natural breath 
without changing it to enhance mindfulness. The intention to maintain attention or 
mindfulness (sthira), comfort and ease (sukha) is highlighted throughout the eMMB. 
We also propose that teaching these skills will increase self-efficacy for pain 
management through providing successful pain management experiences. 
Dealing with modifications. The movements were chosen to be appropriate 
following surgery. Each session contains the same content, but the number of 
repetitions and the magnitude of movements are self-adapted based on how the 
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Selection of instructors. Yoga instructors (one primary, two back-ups) will be 
contracted employees, accredited (i.e., certified as at least 200-hour-level teachers 
with the Yoga Alliance), and experienced teaching patients with medical conditions. 
 
Dose and Implementation of eMMB. A 20-minute eMMB video will be saved as a 
local file on study tablets and/or will be accessible via the internet (participants will 
be given the option to receive a link to the study video via email). Participants will 
also be given a written description of the eMMB practice. Although guidance (i.e., 
supportive accountability60) is important in promoting adherence to eHealth 
interventions, one study of a stress-management intervention found that adherence-
focused guidance (e.g., email reminders, guidance upon request by participants) was 
as good as more resource intensive content-focused guidance.82 Thus, in the proposed 
study, participants will be given the video before surgery and asked to watch it at 
least once before the procedure. The yoga instructor will call participants before 
surgery to initiate additional guidance upon request at any time throughout the study 
and meet with the participant via videoconferencing using Cisco WebEx in the 
privacy of the hospital room the day following surgery (postoperative day 1 or as 
soon as feasible). Cisco WebEx supports compliance with the administrative and 
physical safeguards sections of the final HIPAA Security Rules.83 The yoga 
instructors’ contact information will be provided with the intervention materials 
indicating their hours of availability and expected response time. Instructors will 
attempt to call participants 2 times prior to surgery without leaving a message. 
Participants will be given an option to communicate with instructors via text 
messaging from a Medical Center device to increase convenience of scheduling. 
Meeting live via videoconference will allow yoga instructors to see participants and 
ensure that they feel comfortable completing the movements postoperatively. The 
videoconferencing session will be facilitated by the Project Manager and will be 
audio recorded. If problems transmitting the live intervention occur or it is not 
possible to complete the intervention in the clinical setting, we will have the 
interventionist lead the intervention and answer questions by telephone. Participants 
will be asked to continue to use the video daily for two weeks following surgery and 
as long as they choose thereafter. The Project Manager will monitor patient-reported 
self-directed use of the video and call to check in with all participants after the first 
two days. This dose of content-focused guidance is similar to that found to be 
effective in other brief or primarily self-directed interventions.84,85 For example, 
hypnosis implemented during one 15-minute pre-operative in-person session, with 
instructions for how patients could use hypnosis on their own, reduced postoperative 
pain in women undergoing breast cancer surgery.84 A self-directed approach may also 
empower participants to establish self-regulation strategies. 
 
Attention Control (AC). An AC group focused on providing caring attention will be 
employed to account for the added time, attention, interaction with an interventionist, 
and efficacy expectations of the eMMB as recommended for the study of mind-body 
practices86 and used in previous studies.84,87,88 In addition, the interventionist will ask 
patients to write brief diary entries once before surgery and daily for two weeks 
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REDCap App and/or will be accessible via the internet (participants will be given the 
option to receive a link to the study diary via email). Participants will also be given 
the option to complete a paper diary. The Project Manager will monitor patient-
reported self-directed diary completion and call to check in with participants if they 
have not completed the diary after the first two days. The AC will not include 
instruction of movement, meditation or breathing practices, which are the active 
ingredients of the eMMB. The format for interactions with a professional, amount of 
recommended home practice, and home assessments will be matched to the eMMB. 
The AC interventionist will call participants before surgery to initiate additional 
caring attention upon request at any time throughout the study and meet with the 
participant via videoconferencing following surgery (postoperative day 1 or as soon 
as feasible) for 30 minutes to provide caring attention. The videoconferencing session 
will be facilitated by the Project Manager and will be recorded. The AC will be 
implemented by an individual with experience working in a medical setting who will 
be trained to create and maintain a relationship by using techniques such as active 
listening, reflection of statements, and avoiding negative judgments. S(he) will utilize 
standardized instructions to prompt the patient as adapted from previous 
studies87,89,90: “What were some of the events or circumstances that affected you in the 
past two weeks?” Patients will be encouraged to ‘‘discuss one experience at a time, 
even if it means talking about the same experience each session. However, if you find 
that you have discussed it in adequate detail, please move on to a new topic.’’ The 
instructions for daily diary entries will be, “What were some of the events or 
circumstances that affected you in the past day? Think back over the past day and 
write down on the lines below up to five events that had an impact on you.”90 
5.2 
Handling of Study Interventions  
Participants will be informed that they could be randomly assigned to 1 of 2 different 
supportive treatments with a general description of what they will involve (i.e., 
counseling, gentle movement, writing, and/or relaxation strategies). Information 
about both arms will be revealed to participants after completion of data collection. 
Measurement of intervention fidelity. Recommended steps will be taken to ensure 
treatment fidelity of the videoconference session for both groups to increase 
reproduceability.91,92 The PI and expert yoga therapist (Wheeler) will train the 
interventionists to guide participants on the eMMB. The PI and Dr. Danhauer will 
train the interventionists on the AC. All sessions will be recorded and 20% randomly 
selected for review by Dr. Wheeler (eMMB) or Dr. Danhauer (AC). Further, the 
interventionists and Dr. Wheeler or Dr. Danhauer will meet monthly by phone to 
support them in maintaining familiarity with the protocol. 
5.3 
Concomitant Interventions  
5.3.1 Allowed Interventions 
All participants will continue with routine treatment of medical conditions including 
medications.  

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5.3.2 Required Interventions 
No additional interventions are required except for those propose in the protocol. 
5.3.3 Prohibited Interventions 
 
There will be no prohibited medications among patients in this study. Prior approval 
of participation in other behavioral intervention studies is required.  
5.4 
Adherence Assessment  
Adherence will be assessed by: (1) Completion of the videoconference session; (2) 
any additional contact with the interventionists; (3) use of the self-directed 
intervention: measured daily for up to one week before and one week after surgery as 
assessed in another yoga study38 and self-reported retrospectively (in the past week) 
at postoperative weeks 2 and 4. Instructors will directly observe and document 
adherence to the videoconference session. We will consider adequate adherence to 
protocol if 70% participants complete the planned video conferencing session one day 
of home practice before and 3 or more days of home practice per week for the two 
weeks following surgery.  
 
 

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6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
Assessment 
Screening
: (Day-14 
to Day -1) 
Baseline, 
Enrollment, 
Randomization: 
(Day 0) 
Week 0 
AC or 
eMMB 
(Day1) 
Week1 
Week 2 Follow-up 
(Week 4) 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
Communication with 
Provider 
X 
 
 
 
 
 
 
Informed Consent Form   
 
X 
 
 
 
 
 
Enrollment/Randomization 
 
X 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
Clinical Data  
 
X 
 
 
 
 
X 
Questionnaire 
 
X 
 
X 
 
X 
X 
Daily Survey 
 
 
X 
 
X 
 
 
Actigraphy 
 
 
X 
 
X 
 
 
Treatment Fidelity 
 
 
 
X 
 
 
 
Intervention Home Practice 
 
 
X 
 
X 
X 
X 
Adherence 
 
 
 
X 
 
 
 
Interventionist 
Communication 
 
 
X 
 
X 
 
 
Adverse Events  
 
 
 
X 
 
X 
X 
Interview 
 
 
 
 
 
 
X 
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6.2 
Description of Evaluations  
To minimize burden, assessments, and interviews will be implemented while patients 
are at home or already on site for standard care. At the time of enrollment, 
participants will be provided a tablet computer to borrow for the study (unless they 
already have a comparable device that they prefer) and receive training on completing 
questionnaires either online or by telephone, similar to a training successfully 
implemented in a study of symptom monitoring in this patient population.93 This prior 
study suggested that alternate data collection methods such as automated telephone 
calls may increase adherence to web-based symptom reporting.93 Patient-reported 
questionnaires will be conducted at four time points: before surgery (baseline), one 
day after surgery, two weeks after surgery and 4 weeks after surgery.  
 
We are most interested in assessing and then effectively managing acute within one 
week following surgery when pain is likely to be highest,94 and how pain 
management during this period may ultimately impact longer-term pain. Daily diaries 
are one method for measuring an experience in a participant’s natural setting with low 
patient burden.95 Thus, participants will also be asked to complete daily surveys of 
outcomes and adherence to home practice of the intervention via REDCap and wear a 
wrist actigraphy device for up to one week before and one week following surgery. 
REDCap is a flexible electronic data capture system offered by the Wake Forest CTSI 
that will verify the date and time of assessments implemented via the internet, 
telephone, or paper. Our team has piloted the use of REDCap for implementing daily 
assessments during our ongoing study. Women with gynecologic malignancies have 
demonstrated reasonable compliance (86%) with electronic diary assessment96 and 
daily assessments after gynecologic oncology surgery (68% compliance).94 
Participants will be prompted to complete the surveys (3-5 minutes) at approximately 
6:00pm each evening and can complete the survey any time before they go to sleep. A 
paper guide with response options for the questionnaire will be provided to improve 
comprehension over the telephone. Participants will also be given a wrist actigraphy 
device and instructions for its use during this same time period.  
 
In addition, demographic data will be patient-reported at baseline, medical records 
will be reviewed to obtain clinical data, treatment fidelity observed at the 
videoconference intervention session, and an interview conducted at a follow-up 
clinic visit or by telephone. Participants will be compensated up to $100 total for 
completing study assessments. We will also track recruitment, adherence to the 
videoconference intervention, any other contact with interventionists, completion of 
assessments, and any adverse events that may occur. Those who decline participation 
or drop out of the study will be asked for feedback about their choices. 
 
6.2.1 Screening Evaluation 
Consenting Procedure 
If the patient is interested and referred by the physician, the Project Manager or other 
study team member will approach or call interested patients prior to surgery to 

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explain the protocol, answer questions, determine eligibility, and discuss informed 
consent. After making sure the patient clearly understands the study procedures and 
agrees to follow them, the patient will be asked to sign the informed consent form 
electronically (via REDCap) or in person. Either a hard copy or email attachment of 
the informed consent document will be given to the participant, and the original copy 
will be kept in the participant’s file. Each participant will be asked to separately agree 
to be videotaped for the study, which will not affect their ability to participate. If they 
do consent to be videotaped, they are told in the consent form that they can ask not to 
be included in the filming or withdraw their consent to be videotaped at any time. 
These videos are focused on the interventionist for the sole purpose of increasing 
treatment fidelity. We will also let participants know at the time of consent that it is 
their choice whether or not visitors remain in the room during the intervention and 
ask if they have a preference. 
Screening 
Screening evaluations will begin once a patient is scheduled for a consultation related 
to receiving surgery for a suspected gynecologic malignancy. The allowable range of 
time for screening is up to one year prior to study entry and baseline assessment. 
Electronic medical records of patients planning to receive chemotherapy will be 
reviewed by a study team member to identify potential patients that meet enrollment 
criteria. This screening will consist of: 
• Review of medical history 
• Review of treatment plan 
 
We will approach patients either in person or remotely (e.g., telephone, 
myWakeHealth, mail) regarding their interest in study participation. For patients 
interested in the study, research staff will verify eligibility through patient interview 
regarding medical history. 
 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Enrollment is defined as the randomization date or as the date all of the screening 
criteria are met and the individual agrees to participate. 
 
Registration Procedures 
All patients entered on any CCCWFU trial, whether treatment, companion, or cancer 
control trial, must be registered with the CCCWFU Protocol Registrar or entered into 
Oncology Research Information System (ORIS) Screening Log within 24 hours of 
Informed Consent. Patients must be registered prior to the initiation of treatment.   
 
The following steps must be performed in order to ensure prompt registration: 
 
1. Complete the Eligibility Checklist (Appendix K) 
2. Complete the Protocol Registration Form (Appendix L) 

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3. Alert the Cancer Center registrar by phone, and then send the signed Informed 
Consent Form, Eligibility Checklist and Protocol Registration Form to the 
registrar, either by fax or e-mail. 
 
 
4. Fax/e-mail ALL eligibility source documents with registration. Patients will not 
be registered without all required supporting documents. 
Note: If labs were performed at an outside institution, provide a printout of the 
results. Ensure that the most recent lab values are sent. 
 
 
To complete the registration process, the Registrar will:   
 
 assign a patient study number 
 other appropriate actions 
 register the patient on the study 
Baseline Assessments 
For participants who have successfully been screened for eligibility and are enrolled 
into the study, baseline assessments will be performed. The baseline assessment may 
be completed within two weeks prior to surgery.   
 
• Assessment Completion/Retention. Percent completion of planned standard and 
daily assessments. 
• Pain. The Patient Reported Outcomes Measurement Information System 
(PROMIS) measure of pain of intensity (i.e., How would you rate your pain on 
average?), which has been adapted for assessing pain on a numeric rating scale 
from 0 (no pain) to 10 (worst imaginable pain) “in the last day,”97 is the proposed 
primary outcome (at 2 weeks) for the future larger clinical trial that will be 
informed by the current study. Patient-reported pain is considered the ‘gold 
standard’ for pain assessment since pain is a subjective experience and PROMIS 
is supported by the NCCIH and National Cancer Institute.98,99 Pain interference, 
the affective dimension of pain, and analgesic use will be assessed using 9 
patient-reported items. Pain interference will also be assessed with a PROMIS 
measure (6-items).97 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).84,98,100 Analgesic use in the past 24-hours will be tracked daily for one 
week before and one week post-surgery (postoperative day 1 to 8; day added 
since participants may report information from the prior day) and converted to a 
cumulative analgesic consumption score for analysis (2-items).101 We will also 
ask participants if they are taking any analgesic medication postoperatively.   
• Sleep Disturbance will be assessed with a PROMIS Sleep Disturbance short-form 
(8-items)102 adapted for daily use. 
• Psychological Distress. The PROMIS Depression (8-item) & Anxiety (7-item) 
adapted short-forms will be used to assess psychological distress “in the last 
day.”97 

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• Pain Self-Efficacy will be assessed with the pain management subscale of the 
Chronic Pain Self-Efficacy Scale,103 which has been used postoperatively (5-
items).104 
• Daily Symptoms will be assessed for up to one week before surgery and week 
after surgery starting on postoperative day 1 (or as soon as feasible) using 4 items 
on pain (2), disturbed sleep, and distress. The same adapted PROMIS pain 
intensity item will be asked and sleep disturbance and psychological distress 
items will be used from the MD Anderson Symptom Inventory (MDASI), which 
asks about each symptom at “its worst” in the past 24 hours from the MDASI 
designed to be implemented daily105 and used perioperatively.94 
• Sleep Disturbance will also be assessed with actigraphy, a non-intrusive 
alternative to the traditional polysomnography when monitoring sleep.106 The 
Actiwatch Spectrum model actigraph will be worn for up to 1 week before 
surgery and one week after surgery starting on postoperative day 1. This watch-
like device measures rest/activity patterns in a natural setting, and provides 
summary measures of daily sleep activity. Sleep disturbance will be defined as a 
daily ratio of circadian disruption (the ratio of nighttime activity to daytime 
activity; higher scores show greater circadian disruptions). A similar device and 
the same ratio has been used in patients perioperatively.107 Participants will also 
self-report the time spent napping and their bed and rising times daily.108  
• Demographic Factors.  Age, race/ethnicity, marital status, education level, ability 
to pay for the basics, distance travelled for care, medical history, previous use of 
mind-body practices, baseline level of mindfulness, and internet access will be 
self-reported at baseline.  
• Clinical Factors. Cancer site, type of surgery stratified by risk,109 treating 
physician, date diagnosed, other cancer treatments, comorbidities, height, weight, 
prescription medications for pain, sleep, depressive symptoms, and anxiety will 
be abstracted from medical charts at baseline.  
Randomization 
Randomization will occur the same day that screening is confirmed. Instructions for 
completing the intervention will begin at the same visit.  
6.2.3 Blinding 
• Participants will be told that both groups offer programs to support their 
experience in coping with surgery to match efficacy expectations.  
• The study team member collecting outcome assessments will be blinded to group 
assignment.  
• A complete description of each study arm will be presented to participants upon 
their completion of all study measures. 
6.2.4 Follow-up Visits 
The timing of study assessments is summarized in Table 1. Postoperative day 1 
assessments may be completed within 3 days after surgery. The two-week and 4-
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scheduled within a week of the scheduled assessment. Descriptions of additional 
measures not assessed at baseline include: 
• Adherence. Completion of the videoconference session 
• Interventionist Communication. Any additional contact with the interventionists. 
• Intervention Home Practice. Use of the self-directed intervention (time and 
duration) will be measured daily for up to one week before and one week after 
surgery as assessed in another yoga study.38 Self-reported time of practice will 
also be assessed retrospectively (in the past week) at postoperative weeks 2 and 4. 
• Acute Adverse Events.  Participants will also be asked to complete two Visual 
Analogue Scale items assessing pain intensity and psychological distress daily 
with the instructions to report their experience “right now,” immediately before 
and after the intervention to detect any acute adverse events.65 
• Expected Benefit. The HEAL Treatment Expectancy measure 6-items)110 will 
assess expected benefit of the intervention following the videoconference session.  
• Daily Symptoms will be assessed for up to one before surgery and week after 
surgery starting on postoperative day 1 (or as soon as feasible) for 8 days (since 
participants may report information from the prior day) using 3 items on pain, 
disturbed sleep, and distress. The same PROMIS pain intensity item will be asked 
and sleep disturbance and psychological distress items will be used from the 
MDASI, which asks about each symptom at “its worst” in the past 24 hours from 
the MDASI designed to be implemented daily105 and used perioperatively.94 
• Sleep Disturbance will also be assessed with actigraphy, a non-intrusive 
alternative to the traditional polysomnography when monitoring sleep.106 The 
Actiwatch Spectrum model actigraph will be worn for up to 1 week before 
surgery and one week after surgery starting on postoperative day 1. This watch-
like device measures rest/activity patterns in a natural setting, and provides 
summary measures of daily sleep activity. Sleep disturbance will be defined as a 
daily ratio of circadian disruption (the ratio of nighttime activity to daytime 
activity; higher scores show greater circadian disruptions). A similar device and 
the same ratio has been used in patients perioperatively.107 Participants will also 
self-report their bed and rising times daily.108  
• Patient Provider Connection will be measured with a 7-item short-form from the 
Healing Encounters and Attitudes Lists (HEAL)110 at the 4-week follow-up visit. 
• Clinical Factors. Medications prescribed for pain, length of stay, any 
complications experienced, and other cancer treatments, will also be abstracted 
four weeks post-surgery. 
6.2.5 Completion/Final Evaluation 
Assessments to be performed at the participant’s final visit are described in the prior 
section. Participants who discontinue study the intervention early will require no 
specific evaluations. The reason for discontinuation will be documented. We will 
contact participants to obtain follow-up data remotely if they discontinue participation 
due to change in treatment location. Patients terminated from the study will undergo 
no further monitoring once they have stopped the study intervention.  

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7. SAFETY ASSESSMENTS  
Expected adverse experiences for each study intervention are as follows: 
            EMindful Movement and Breathing 
• Emotional discomfort  
• Muscle soreness  
Active Control 
• Emotional discomfort  
Each interventionist will monitor and note any adverse events experienced during the 
videoconferencing (e.g., patients’ experience of disturbed breath, expression of 
physical/emotional discomfort, or request to discontinue the in-person intervention 
sessions). In addition, study staff will ask participants if they experienced any problems 
when doing the home practices and review notes from the home practice logs at follow-
up visits. Instructors will have phone numbers for the triage nurse and Cancer Support 
Services available to give to patients as referrals if patients tell them about any clinical 
issues that arise. Study staff will also document in the electronic patient records using a 
telephone note if a referral number was provided. 
 
Two or more adverse events attributable to the interventions will prompt modification of 
the protocol.          
7.1 
Specification of Safety Parameters 
See previous section for safety parameters. 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Overall, risks related to the interventions in this study are considered to be minimal 
and are addressed in the protocol and consent form. The study employs gentle in bed 
movement, breathing and meditative practices or caring attention among people 
undergoing surgery for a suspected gynecologic malignancy. Similar yoga 
interventions have been conducted in patients with cancer with no published reports 
of adverse events, some which included participants during the perioperative 
period.40,65 The PI conducted an initial pilot study of 10 participants with the 
proposed yoga intervention implemented perioperatively in-person at WFBCCC from 
05/2012 – 05/2013.65 There were no adverse events observed related to the yoga 
practice in this study. 
 
The PI will monitor the safety of participants on an ongoing basis by inquiring about 
each participant’s emotional and physical reactions during all regular study meetings 
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appropriate. The PI will initially assess if the AE is related to the study interventions 
as definitely, probably, possibly or unrelated. 
7.3 
Adverse Events and Serious Adverse Events  
 
CTCAE term (AE description) and grade:  The descriptions and grading scales found 
in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) 
version 4.0 will be utilized for AE reporting. All appropriate treatment areas should 
have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 
can be downloaded from the CTEP web site (http://ctep.cancer.gov).   
 
‘Expectedness’: AEs can be ‘Unexpected’ or ‘Expected’ for expedited reporting 
purposes only.   
• 
Attribution of the AE: 
 
- 
Definite – The AE is clearly related to the study intervention. 
- 
Probable – The AE is likely related to the study intervention. 
- 
Possible – The AE may be related to the study intervention. 
- 
Unlikely – The AE is doubtfully related to the study intervention. 
- 
Unrelated – The AE is clearly NOT related to the study intervention. 
 
SAEs unequivocally due to disease progression are not considered SAEs for the 
purposes of this study and will not be reported as such.  
Only AEs related to the study intervention or measures will be captured with the 
exception of unexpected grade 4 Grade 5 events, which will also be documented and 
reported. 
AEs will be labeled according to severity, which is based on their impact on the 
patient. An AE will be termed “mild” if it does not have a major impact on the 
patient, “moderate” if it causes the patient some minor inconvenience, and “severe” if 
it causes a substantial disruption to the patient’s well-being.  
AEs will be categorized according to the likelihood that they are related to the study 
intervention. Specifically, they will be labeled definitely unrelated, definitely related, 
probably related, or possibly related to the study intervention. 
Interventionists will document and report solicited AEs including physical or 
emotional discomfort. Research staff will report AEs according to data safety 
monitoring plan. Events will be documented including date of event which will avoid 
double capture. 
7.4 
Reporting Procedures 
AEs reports will be distributed to the Independent Monitoring Committee (IMC) 
electronically via email.  
 

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The IMC will monitor and review adverse events and events that may be related to 
the intervention. This will include verification that, when indicated, these events have 
been reported to the appropriate agencies (e.g. IRB, NCCIH) and that such reports 
have been made in a timely manner. Non-serious adverse events will be reviewed on 
a quarterly basis by the IMC. The IMC will be notified of serious adverse events 
within 24 hours of occurrence and reviewed within 48 hours.  
 
SAEs that are unanticipated, serious, and possibly related to the study intervention 
will be reported to the IMC, IRB, and the National Center for Complementary and 
Integrative Health (NCCIH) by sending the SAE Report Form via email (Appendix 
N: Adverse Event Form). The CCC-WFU Safety and Toxicity Reporting Committee 
(STRC) will also review unexpected grade 4 and all grade 5 events regardless of their 
attribution. 
 
• Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the NCCIH Program Officer within 7 days. Other serious and 
unexpected AEs related to the intervention will be reported to the NCCIH 
Program Official within 15 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the Independent Monitor(s), IRB, NCCIH, and other oversight 
organizations in accordance with their requirements. In the annual AE summary, 
the Independent Monitor(s) Report will state that they have reviewed all AE 
reports. 
7.5 
Followup for Adverse Events 
AEs will be monitored by the IMC and the PI for recurrences, resolution, and ongoing 
toxicities that may be related to the intervention. Documentation and reporting for 
follow-up AEs will occur according to reporting procedures described in Section 7.4. 
The duration for follow-up will be for the length of the study period while 
participants are enrolled in the study. If non-serious adverse events are related to the 
interventions, then the protocol will be modified to avoid adverse events. If the 
frequency of non-serious adverse events is higher than anticipated or alters the benefit 
risk ratio, the study investigators, after conferring with IMC, will also modify the 
protocol.  Two or more specific adverse events among participants will prompt 
modification of the protocol.           
7.6 
Safety Monitoring  
The Independent Monitoring Committee (IMC) for this study is comprised of the 
Wake Forest School of Medicine’s Institutional Data and Safety Monitoring Board 
members who have expertise in clinical trial methodology and conduct, biostatistics, 
ethics, and clinical research. The Institutional Data and Safety Monitoring Board 
members are not part of the key personnel involved in this grant. They are qualified to 
review the patient safety data generated by this study because of their unique 
expertise in the areas of oncology, mental health/ethics and statistics.  

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Study progress and safety will be reviewed quarterly (and more frequently if needed). 
Progress reports, including patient recruitment, retention/attrition, and AEs will be 
provided to the Independent Monitor(s) following each of the quarterly reviews. An 
Annual Report will be compiled and will include a list and summary of AEs. In 
addition, the Annual Report will address (1) whether AE rates are consistent with pre-
study assumptions; (2) reason for dropouts from the study; (3) whether all participants 
met entry criteria; (4) whether continuation of the study is justified on the basis that 
additional data are needed to accomplish the stated aims of the study; and (5) 
conditions whereby the study might be terminated prematurely. The Annual Report 
will be sent to the Independent Monitor(s) and will be forwarded to the IRB and 
NCCIH. The IRB and other applicable recipients will review progress of this study on 
an annual basis. The PI will also send copies of signed recommendations and 
comments from the Independent Monitor(s) or Chair of the IMC to the NCCIH 
Program Officer within 1 month of each monitoring review.   
8. INTERVENTION DISCONTINUATION  
The intervention will be discontinued for a participant if: (1) the intervention is 
associated with an adverse effect for a specific participant (i.e., participant does not 
tolerate the intervention), (2) the participant no longer is interested or willing to 
receive the intervention or participate in the study, or (3) the participant’s healthcare 
provider no longer recommends that the patient receive the intervention for medical 
reasons. The IMC and the principal investigator will review cases upon occurrence 
for discontinuation of intervention. 
This study will be stopped prior to its completion if: (1) the intervention is associated 
with adverse effects that call into question the safety of the intervention; (2) difficulty 
in study recruitment or retention will significantly impact the ability to evaluate the 
study endpoints; (3) any new information becomes available during the trial that 
necessitates stopping the trial; or (4) other situations occur that might warrant 
stopping the trial. The PI will include an assessment of futility in the annual progress 
report to NIH and will consult with the study monitors to assess the impact of 
significant data loss due to problems in recruitment, retention, or data collection. 
 
Participants will be followed with their permission if the study is discontinued. The 
duration of follow-up will be length of the proposed study. We will continue to 
document adverse events during the follow-up period. 
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
Inclusion of an active control group was chosen to account for Hawthorne effects, 
attention from a professional, and other non-specific effects. Alternate control groups 
considered include a wait-list control group or stretching. Specifically, the proposed 
empathic attention control was chosen to control for the non-specific effects of the 
intervention without including any of the proposed active intervention components.  
 

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Stratified randomized control design was selected for this study to enable tighter 
control over known influences on outcome. Statistical control via covariate analysis 
would not suffice. 
1. Primary Hypothesis: We hypothesize that we will enroll at least 50% of eligible 
patients, participants will adhere to 70% of the interventions, and at least 70% of 
participants will complete study assessments and be retained in the study.  
Secondary:  
2. We will describe any adverse events reported as frequencies. 
 
3. Assess descriptive data on proposed outcomes (i.e., pain [primary outcome  - pain 
interference at week 2], sleep disturbances, psychological distress) for the next 
phase of study;  
 
The Patient Reported Outcomes Measurement Information System (PROMIS) 
measure of pain of intensity (i.e., How would you rate your pain on average?), 
which has been validated for assessing pain on a numeric rating scale from 0 (no 
pain) to 10 (worst imaginable pain) “in the last day,”97 is the proposed primary 
outcome (at 2 weeks) for the future larger clinical trial that will be informed by 
the current study. Patient-reported pain is considered the ‘gold standard’ for pain 
assessment since pain is a subjective experience and PROMIS is supported by the 
NCCIH and National Cancer Institute.98,99 
 
4. Qualitatively assess acceptability to guide future study planning.  
 
9.2 
Sample Size and Randomization 
The target sample size is based on the goals of estimating the rates of feasibility 
measures (i.e., recruitment, adherence, assessment completion, adverse events and 
retention rates) to inform the design of a larger efficacy trial. This current pilot study 
is not designed to assess the effect of the eMMB on any outcome. Thus, we will 
accrue a total of 31 participants, because this number provides reasonably tight 
estimates of our parameters of interest. We will be able to estimate these rates within 
+/- 18% using a two-sided 95% confidence interval, and within 9-15% using a one-
sided interval (dependent on the observed proportion). If the recruitment rate is below 
50% and the adherence and retention rates are below 70% (i.e., 30% drop-out or non-
adherence), a larger study may not be feasible. That is, with an observed retention 
rate of ≥80% (20% lost to follow-up, target N=25 and lost to follow-up N=6) we can 
be highly confident that the true rate is at least 68% (the lower limit of a one-sided 
95% CI for an observed rate of 80% is 68.2%). An adequate retention rate for Week 2 
data will be an indicator that this study is successful and we are ready to proceed to 
the next phase of study. 
 
Power calculations for a subsequent larger study will be based on clinically 
meaningful differences between the groups on the primary outcome.112 The number 
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reached. As is conventional for thematic analysis, we will conduct interviews until we 
think there is enough qualitative data to address issues related to the acceptability of 
study procedures. 113 The study team’s experience leads us to believe that 10-15 
interviews from each of the two arms will be sufficient to achieve this objective. Our 
analyses of differences between cancer type and invasiveness will be for exploratory 
purposes and therefore data saturation using those variables is not the goal. If 
unexpected information emerges and our timeline allows, we will consider amending 
the protocol to recruit additional participants. 
Treatment Assignment Procedures 
Eligible, consented, and enrolled participants will be randomized to eMMB or AC. 
To control for type of cancer and invasiveness of surgery, randomization will occur 
within cancer type (uterine or ovarian) and surgery type (laparotomy or robotic). 
There is not a sample size goal within strata.  
 
Randomization (1:1) lists within each strata will be generated. Study team members 
who are collecting outcome data will not be informed of group assignment.  
9.3  
Definition of Populations 
We will use the revised CONSORT 2010 guidelines for intention-to-treat (ITT) 
analysis of randomized control trials114 in our sample considerations. Those 
guidelines dropped specific ITT in favor of clear descriptions of exactly who would 
be (or was) included in the analysis per our specification above. We also took into 
account considerations for minimizing missing data within the context of ITT 
specified by White et al.115 We have incorporated flexible windows for the data 
collection in our protocol and are allowing for possible randomly missing interim 
assessments. Therefore the population to whom these pilot findings will be 
generalizable to will be that represented by the sample meeting our requirements for 
inclusion in the ITT sample. 
9.4 
Interim Analyses and Stopping Rules 
There are no interim analyses planned for this clinical trial. Summaries of process 
variables (i.e., recruitment, adherence, data collection, adverse events, retention) will 
be conducted on a rolling basis as the study progresses. The PI will present data on 
subject accrual to the Independent Monitoring Committee (IMC). Based on the 
Cancer Registry at WFBCCC from 2015-2017 an average of 128 patients/year had 
surgery for uterine or ovarian cancer (73% uterine; 27% ovarian). Therefore, 
assuming 80% of patients are eligible (n=102), and that we can recruit about 30-50% 
of those eligible (n= 31-51), we anticipate recruiting 31 participants over 
approximately 8-16 months (2-4 per month). Fidelity of implementing the 
interventions will also be evaluated during the study period. If we document fidelity 
less than 80% during the clinical trial, than interventionists will undergo further 
training with subsequent re-evaluation demonstrating sufficient fidelity.  
 
Futility analyses for efficacy or safety will not be conducted in this pilot study. SAE’s 
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a safety review is convened (either routine or ad hoc) by IMC to determine whether 
the study intervention should continue per protocol, proceed with caution, be further 
investigated, discontinued, or be modified and then proceed. If SAEs events are 
related to the interventions, then the relevant intervention protocol will be modified to 
avoid adverse events. If the frequency of non-serious adverse events is higher than 
anticipated or alters the benefit risk ratio as determined by the IMC and PI, the study 
investigators will also modify the relevant intervention protocol. Two or more 
specific adverse events among participants will prompt modification of the protocol.    
9.5 
Outcomes  
The study team member collecting outcome data will be masked to the participant’s 
intervention group assignment.  
9.5.1 Primary Outcome   
The primary study outcome is feasibility (i.e., recruitment, adherence, assessment 
completion, and retention rates)  
 
9.5.2 Secondary Outcomes   
Secondary outcomes include proposed outcomes (i.e., pain [primary outcome  - pain 
interference at week 2], sleep disturbances, psychological distress) for the next phase 
of study. The Patient Reported Outcomes Measurement Information System 
(PROMIS) measure of pain of intensity (i.e., How would you rate your pain on 
average?) is the proposed primary outcome (at 2 weeks) for the future larger clinical 
trial that will be informed by the current study.  
 
Adverse events and qualitative data will also be collected.  
9.6 
Data Analyses  
This study will provide quantitative data on recruitment, adherence, assessment 
completion, adverse events and retention rates and qualitative assessment of 
acceptability to guide future study planning. We will calculate 95% confidence 
intervals for each of the feasibility measures to determine the range of estimates that 
are consistent with our data. We 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 the eMMB and AC 
sessions and those who completed all assessments will be computed; we will also 
calculate the frequency of any adverse events and percent of participants who 
complete the 2w visit to assess retention. We 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. In exploratory analyses, we 
will compare participants who are non-adherent or who drop out by demographic 
characteristics, intervention group, and baseline scores of the measures. We will also 
investigate any differences in participant recruitment, adherence, assessment 

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completion, adverse events, and retention rates by surgery type and cancer type to 
identify an optimal patient population for a future study.  
 
Baseline analyses will include descriptive statistics of pain (i.e., intensity, 
interference, affective, analgesic use), sleep disturbance (patient-reported), 
psychological distress, background characteristics (i.e., demographic) and other 
possible confounding variables (e.g., type of cancer, type of surgery, medications) by 
intervention group. The distributions of continuous variables will be examined to 
determine the presence of outliers and whether transformations are necessary for 
analysis. 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 ANCOVA models (adjustment for baseline) to 
model the trajectory of pain (and sleep disturbance and distress) by time and group 
accounting for the repeated measures on a subject; if any meaningful differences 
between the groups are found at baseline, we will include them in these models. 
Analgesic use will be modeled in a similar manner using a GEE model with a logit 
link. We will also use mixed models to examine the daily actigraphy, pain, and other 
symptom data by group and time. The purpose of all of these models will be to obtain 
estimates of the SD of change adjusted for covariates of interest and the within-
person correlation of the repeated measures, not to perform formal hypothesis testing. 
In exploratory models we will examine the impact of adherence to eMMB on changes 
in the measures, subgroup analysis by surgery type, and we will examine the role of 
pain self-efficacy as a potential mechanism. The purpose of these analyses will be to 
estimate SD and within-person correlation by subgroup and with adjustment for 
mechanisms; no formal hypothesis testing will be done. We will also examine the 
validity of the patient report for intervention practice by examining the concordance 
between the self-report of MMB practice and the activity level on the accelerometer. 
 
Interview transcripts will be coded independently by two staff members of the QPRO 
Core. Twenty-five percent of the transcripts will be coded independently by two 
separate coders to ensure consistency of code application.  Unresolved discrepancies 
reconciled by a third person. Using thematic analysis, the coded text will be 
iteratively reviewed and interpreted.113 The qualitative and quantitative analyses will 
be evaluated in a mixed-methods framework for consistency and discrepancies to 
refine the protocol for future studies. For example, if the qualitative interviews 
indicate that a particular subgroup of patients (e.g., by cancer type, surgery type ) 
perceive greater benefit from the eMMB, then we will perform exploratory subgroup 
analysis of the quantitative data.  
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Questionnaires will be collected by a blinded study team member (Clinical Studies 
Coordinator). Questionnaires will either be completed directly in REDCap or using 
paper forms. Data records for each participant will be identified by a unique study 
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forms which only have ID numbers will be stored in a locking cabinet at WFBCCC or 
in the PI’s office building while on study. Data from these documents, clinical data 
from the medical chart and data collected via daily automated surveys will be entered 
into a REDCap database at Wake Forest University. The actigraphy data, audio 
recorded semi-structured interviews and videos of the intervention sessions will also 
only be coded by study ID number.  
 
All participants will be assigned a study ID number; however, it is necessary for the 
study team to know participants names during time on-study. Names will be 
maintained in a participant tracking database accessible only to approved study staff 
through password protected files stored on a secure server, not on laptops or thumb 
drives. To protect confidentiality, all data will be stored in a locked file cabinet 
located in the secured office of a study team member or PI. All computers and data 
files will be password protected. All data processed will be in aggregate form and 
data collection forms will only be labeled with participant’s unique identification 
number.  
10.2 Data Management  
The clinical site will not be responsible for data collection or management. Some data 
will be extracted from the medical record at the clinical site, though this data is part 
of routine monitoring and care of the patients. 
Outcomes and stored as summarized in the following table. 
Summary of Data Storage  
Informed consent document 
Electronic Medical Record 
Protocol registration form 
OnCore 
Study questionnaires  
REDCap 
Daily survey data 
REDCap 
Treatment fidelity data 
REDCap 
Clinical data 
REDCap 
Actigraphy data 
Excel Files on Secure Server 
Adherence data 
REDCap 
Qualitative data 
Files on Secure Server 
Adverse events 
OnCore 
10.3 Quality Assurance  
10.3.1 Training 
All research staff will have completed the online Collaborative Institutional Training 
Initiative Training (CITI) prior to participation in research activities. Dr. Sohl will 
directly oversee training of research staff in regards to conducting the planned 
research.  
10.3.2 Quality Control Committee  
The study team will generate Study Reports for the IMC and will provide information 
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adherence to the interventions, and adverse events that may be related to the 
interventions. 
The frequency of review for this study differs according to the type of data and can be 
summarized in the following Table. 
Frequency of data review 
Data type 
Frequency 
of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Quarterly 
PI, Independent Monitor(s) 
Status of all enrolled subjects, as of 
date of reporting  
Quarterly 
PI, Independent Monitor(s) 
Adherence data regarding study 
visits and intervention 
Quarterly 
PI, Independent Monitor(s) 
AEs and rates  
Quarterly 
PI, Independent Monitor(s) 
SAEs 
Per 
occurrence 
PI, Independent Monitor(s), 
IRB, NCCIH 
10.3.3 Metrics 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria 
will occur monthly by the PI during the first three months and then every quarter to 
ensure that a sufficient number of participants are being enrolled and that they meet 
the targeted ethnic diversity goals outlined in the grant proposal. 
Dr. Sohl or study staff will also review all data collection forms on an ongoing basis 
(i.e., quarterly) for data completeness and accuracy as well as protocol compliance. A 
study member not involved in data collection will enter the data collected via paper 
questionnaires. At least ten percent of all data entered from questionnaires will be 
randomly selected and verified for accuracy against original source documents. Any 
discrepancies will be discussed with the Independent Monitors. Data will also be 
reviewed for outliers and to determine if values are missing at random prior to 
analysis. Dr. Sohl will provide quarterly updates to the IMC and research mentors 
regarding patient accrual. 
 
10.3.4 Protocol Deviations 
Protocol deviations will be captured through direct observation by research staff 
regarding patient recruitment and enrollment, intervention administration, adherence, 
and safety monitoring. Protocol deviations will be reviewed by the principal 

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investigator and discussed with research mentors and as needed with the IMC. 
 
10.3.5 Monitoring 
Dr. Sohl will monitor for protocol compliance, data quality, and review of 
documentation to assure protocol compliance. This will include review of informed 
consent process (upon enrollment), adverse event reporting (upon occurrence), and 
data collection (monthly).    
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent document and any subsequent modifications 
will be reviewed and approved by the IRB or ethics committee responsible for 
oversight of the study.  
11.2 Informed Consent Forms 
Written informed consent will be obtained from each subject at entry into the study. 
Informed consent is obtained by the following process: 
1. The patient will be asked to review the study consent form. 
2. The PI or another study team member will meet with the patient either in person 
or by telephone to review the form, to confirm the patient understands the study, 
and to answer any questions that the patient might have. 
3. Once the patient demonstrates understanding of the study and agrees to participate 
in the study, the consent will be signed remotely or in person. If signed remotely, 
patients will be asked to send the form back to us by a secure means, as well as 
bring the original with them to their next clinic visit.  
 
A copy of the consent form will be given to the participant the next time they are in 
clinic, and the original copy will be kept in the participant’s file. Patients who cannot 
consent for themselves in English will not be eligible to participate. 
11.3 Participant Confidentiality  
Any data, forms, reports, video recordings, and other records that leave the site will 
be identified only by a participant identification number (Participant ID, PID) to 
maintain confidentiality. All records will be kept in a locked file cabinet. All 
computer entry and networking programs will be done using PIDs only. Information 
will not be released without written permission of the participant, except as necessary 
for monitoring by the IRB and the NCCIH. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, or other 
government agencies as part of their duties to ensure that research participants are 
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12. COMMITTEES 
The Independent Monitoring Committee (IMC) for this study is comprised of 
members of the Wake Forest School of Medicine’s Institutional Data and Safety 
Monitoring Board who are not associated with this research project and thus work 
independently of the PI, Dr. Stephanie Sohl. They are not part of the key personnel 
involved in this grant. They are qualified to review the patient safety data generated 
by this study because of their respective unique expertise in the areas of oncology, 
mental health/ethics and statistics.  
13. PUBLICATION OF RESEARCH FINDINGS  
Any presentation, abstract, or manuscript will be made available for review by the 
sponsor and the NCCIH prior to submission.  
14. REFERENCES  
 
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15. SUPPLEMENTS/APPENDICES