Feasibility and Preliminary Efficacy of an Internet-based Pre-surgical Pain Psychology Intervention: A Randomized Controlled Pilot Study of "My Surgical Success"
Phase: NA
Conditions: Breast Cancer
Sponsor: Stanford University

 
 
My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention 
 
NCT03076190 
7/15/2014 
Beth Darnall, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
 
The primary purpose of this study is to determine the feasibility of delivering a psychoeducational 
pain coping skills video to patients pre-operatively. We also aim to characterize the response to 
the video, in terms of participant satisfaction, perceived usefulness, and likelihood to use the 
skills learned. We will follow participants post-surgically to determine the impact of the video on 
post-surgical distress, pain, and use of pain medications. The proposed research will advance our 
understanding regarding the feasibility and effectiveness of remote psychoeducation interventions 
in terms of impact on post-surgical outcomes 
b. 
Objectives 
We hope to learn how a brief psychoeducational video intervention provided pre-operatively may 
affect pain, mood, and opioid use after surgery and throughout recovery. Completion of this 
study will ideally demonstrate good feasibility and acceptability of this video intervention—one 
that is viewed in one’s own home. This study is our first step in broadening access to low-
cost, efficiently delivered specialized pain psychology care. If successful, our study will tell us 
which patients are most receptive to this type of intervention, and thus will inform future studies. 
Additionally the proposed study will provide preliminary data for a future randomized controlled 
study to compare the effectiveness of the pain psychology video intervention to a general 
wellness video. 
c. 
Rationale for Research in Humans 
The aims of this study include examining psychological factors and examining the efficacy of a 
psychoeducational intervention on surgical patients. There are no adequate animal models to test 
the complex psychosocial dimensions that appear so important in the persistence of pain in people 
2. 
STUDY PROCEDURES 
a. 
Procedures 
I. Recruitment:  
Surgeons, anesthesiologists, and the pre-operative clinic will refer interested patients and 
veterans. Patients will receive a form at their normal pre-operative clinic appointment asking 
whether they'd like to receive more information about potential research studies, or will be asked 

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by their regular clinical provider or intake staff whether they are interested in speaking with the 
research team. Additionally, patients who inquire based on word of mouth knowledge, or based 
on approved advertisements will be screened. A member of the research team will then contact 
them via phone to discuss the study and perform initial screening. In-person screening can be 
an alternative to the phone screen, should individuals express interest to their provider on the day 
of their appointment and a researcher is available to speak with them at that time. Patients may 
also receive an email following their clinic appointment with a link to the HIPAA-compliant, 
secure REDCap study screening form.  
 
II. Screening and consent:  
Those indicating interest in participating will be contacted to describe the study and will be asked 
preliminary eligibility questions either at their clinic visit or later by phone or through an emailed 
link to the HIPAA-compliant, secure REDCap screening form. After confirming eligibility, we 
will obtain informed consent (HIPAA embedded for Stanford participants, and with additional 
HIPAA form for VA participants). Consent may be obtained over the phone if an in-person visit 
is not possible. Patients who are spoken with over the phone, will have a consent form mailed or 
faxed to them, or may schedule a visit to the lab if requested. The researcher will then go through 
the entire consent process over the phone with the patient. Eligibility and signatures will be 
verified upon receipt by the research team if the consent process was conducted over the phone. 
Alternatively, the research team may provide the patient with a link to a video that covers the 
content of the consent form, which can be viewed at the patient’s convenience. If the patient opts 
to view the video, the research team has been trained to confirm understanding of the elements of 
consent with the participant (via phone, email, or other correspondence) before the research 
staff signs the consent form and verifies informed consent.  
 
To reduce Stanford participant burden, participants will have the option to document their consent 
to participate via e-signature, utilizing REDCap- a secure, HIPAA compliant, online system that 
is 21 CFR Part 11 compliant. The research team member obtaining consent will then provide 
his/her e-signature documenting and verifying informed consent. The research team has been 
trained to not provide his/her e-signature on the document until speaking with and confirming the 
participant has understood all the elements of informed consent. If the participant's electronic 
signature occurs at a time when the person obtaining consent is out of the office, there might be a 
signature date difference between the e-signature dates of the participant and the person obtaining 
consent. E-consenting will not be performed with VA participants due to technical difficulties.  
    
Alternatively, if the participant does not have access to the internet or wishes not to provide an e-
signature then the participant may provide his/her signature on a hard copy document then fax or  
mail the consent form to the research team. The research team will not seek an original signature 
for consent forms received via fax or mail but will retain and sign the copy received. Consent 
forms that are mailed to the research team will likely have a different signature date as the 
research team will review and sign upon receipt. Consent may also be obtained in-person, if 
requested, by either scheduling a visit to our research offices or during the patient's clinic visit if 
the research team is available at the patient's clinic visit.  
 
Those not wishing to participate will be asked for permission for the study team to collect de-
identified data from their medical record or directly from them for the purposes of baseline 
comparisons between patients who enroll and those that do not. After enrolling, participants may 

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receive a thank you email from the study team.  
 
III. Pre-surgical assessment and procedures:  
   To help ensure relatively equal numbers in both groups, an 8:2 of video group to printed 
information group randomization scheme may be used when group numbers are unbalanced and a 
1:1 randomization scheme of video group to printed information group will be used when the 
group numbers are balanced. Participants assigned to the printed information group who have 
visual impairment and difficulty reading print material will be reassigned to the video group. All 
participants will be asked to provide demographic information, as well as fill out a variety of self-
reported measures assessing mood, pain, cognitive and emotional responses to pain, 
catastrophizing, self-efficacy, and medications. These measures will be provided via a secure, 
HIPAA compliant, online system such as REDCap or Qualtrics. Alternatively, participants may 
receive those measures via regular mail, should they choose to do so. The survey may sometimes 
include questions monitoring depression and suicidal ideation. Should the surveys include such 
questions, responses will be monitored on a weekly basis for completeness and trigger questions 
such as depression and suicidal ideation. Patients exhibiting signs of depression or endorsing 
suicidality will be referred for counseling or immediate assessment as described in section 9a.  
 
Prior to surgery, participants who have been randomized to the printed information group will 
receive patient handouts (either printed or a web link) about health and nutrition that are  
relevant for people recovering from surgery. Handouts may be selected from the VA "move" 
program that was designed by the VHA National Center for Health Promotion & Disease 
Prevention, from other Stanford handouts that are given to patients as standard of care, or from 
the National Comprehensive Cancer Network, depending on the specific participant  
sub-population. Participants randomized to the video group will be provided with a link via a 
secure, HIPAA compliant, online system such as REDCap, to a coping skills psychoeducational 
video. The video content includes instruction by Dr. Beth Darnall, a pain psychologist at 
the Stanford Pain Management Center, who teaches the viewer about the relationship between 
stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, 
decrease stress, and increase relaxation. Patients will be instructed to watch the video 
and participate in a post-video questionnaire to gain feedback on the video and to ensure the 
patient participated in watching and has understood the content of the video.  
 
IV. Follow-up:  
A. Post-video follow-up:  
Participants may be contacted, after viewing the coping skills video, by Dr. Beth Darnall or the 
research staff to provide additional support and further instructions or clarification on 
the application or practice of skills described in the video. Participants are also encouraged in the 
video to reach out to the instructor, Dr. Beth Darnall, with any questions or for assistance.  
 
B. Pre-surgery follow-up: Prior to or on the day of surgery, participants may also be contacted by 
phone to collect further baseline information.  
 
C. Post-surgical follow-up:  
Following surgery, all study participants will be followed as described below.  
 

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1) Additional assessments: Patients may also be asked to complete over the phone or online 
assessments (using a secure, HIPAA compliant, online survey system) of mood, pain, 
catastrophizing, skills use, medication use, and pain self-efficacy after surgery  
at 2,4,8,& 12 weeks post-surgery. Alternatively, participants may receive those measures via 
regular mail, should they choose to do so. Follow-up may be extended or modified, at the 
discretion of the investigator, beyond 3 months from the date of surgery 
to accommodate patient’s scheduling and completion of the assessments. All questionnaires that 
may be used are attached in section 16.  
 
2) Additional follow-up:  
A study team member may also access the patient’s medical record to obtain important study 
related information including surgical information, anesthetic information, medical history, 
medication use, physical exams, and pain-related information for the purpose of  
follow-up throughout the study.  
 
After study completion, participants may continue to be contacted at 6 month intervals for up to 
10 years to assess mood, pain, cognitive and emotional responses to pain, current medical status, 
and medications, unless the patient prefers not to be contacted at these additional time points or 
has requested to no longer be contacted by the research team.  
        
Participants may also be mailed a thank you and/or newsletter with updates on this study and 
other studies in our lab; This is a standard newsletter template used throughout the lab to 
update participants on study progress, website and contact information, and general information 
on the lab and personnel. The newsletter content will vary depending upon date and will be 
modified accordingly at each date. 
b. 
Procedure Risks 
Risk is minimal. All members of the study team receive extensive training on appropriate 
research conduct and data security 
 
c. 
Use of Deception in the Study 
NA. No deception will be used in this study. 
d. 
Use of Audio and Video Recordings 
NA 
e. 
Alternative Procedures or Courses of Treatment 
Standard of care is not being withheld. The alternative is to not participate 
f. 
Will it be possible to continue the more (most) appropriate therapy for the participant(s) 
after the conclusion of the study 
Not relevant. No treatments are being withheld due to participation  
in the study 
 

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g. 
Study Endpoint(s) 
The study will end when all participants have completed research  
procedures. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
The proposed study aims to investigate response to a 2 hour psychoeducation video that is 
treatment for pain catastrophizing. Pain catastrophizing is foremost among the psychological 
factors that worsen pain and contribute to pain chronicity. Pain catastrophizing is defined as 
persistent negative cognitive and emotional responses to actual or anticipated pain [1]. In 
part, pain catastrophizing contributes to a cycle of futility in the medical treatment realm because 
it undermines behavioral and medical treatments [2-9].  
     Across chronic pain conditions, pain catastrophizing has been associated with an array of 
negative phenomena including greater pain intensity [10-15], affective distress [6], muscle and 
joint tenderness [11], muscular tension at rest [16], pain-related disability [11, 12, 14, 17-19], 
poor response to various pain treatments [6, 16, 20] including surgery [14, 21], and to greater use 
[21] and misuse of opioids [22].  
     Pain catastrophizing is also harmful in the context of acute pain and even for individuals who 
are pain-free because pain catastrophizing is associated with increased risk for developing chronic 
pain. In combination, data from multiple studies show that pain catastrophizing is detrimental, 
and that early treatment for pain catastrophizing may serve as chronic pain prophylaxis.  
     Standard PC treatment involves multiple sessions of cognitive behavioral therapy that pose 
substantial burden to patients in terms of cost, travel, and time. Often, these burdens stand as  
barriers to care, thus leaving pain catastrophizing untreated. To provide efficient, low-cost 
treatment, we developed at Stanford a single-session, 2-hour class that solely treats PC 
(‘From Catastrophizing to Recovery’; FCR). We conducted an uncontrolled prospective pilot 
study to test the FCR class intervention in 76 patients with chronic pain in the Stanford Pain 
Management Center [23]. The Pain Catastrophizing Scale was administered at class baseline and 
post-class at 2 weeks and 4 weeks. Feasibility was demonstrated, and anonymous post-class 
surveys indicated excellent ratings for participant satisfaction with the class, usefulness of the 
information presented, ease of understanding the material presented, and likelihood to use the 
skills and information learned. Participants had significantly reduced PC at both post- class time 
points (p<.0001) and large effect sizes were found (2 week Cohen’s d = 0.85 and 4 week d = 
1.15). Thus, our preliminary data suggest that the in-person class format of FCR is acceptable and 
effective treatment for PC [23]. In the proposed study we aim to determine the feasibility and 
utility of the video format of FCR.  
 
b. 
Findings from Past Animal Experiments 
NA 
4. 
RADIOISOTOPES OR RADIATION MACHINES 
a. 
Standard of Care (SOC) Procedures 

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Identify Week/Month of 
Study 
Name of Exam 
Identify if SOC or 
Research 
NA 
NA 
NA 
b. 
Radioisotopes 
i. 
Radionuclide(s) and chemical form(s) 
NA 
ii. 
Total number of times the radioisotope and activity will be administered (mCi) and 
the route of administration for a typical study participant 
NA 
iii. 
If not FDA approved: dosimetry information and source documents (package insert, 
Medical Internal Radiation Dose [MIRD] calculation, and peer reviewed literature) 
NA 
c. 
Radiation Machines – Diagnostic Procedures 
i. 
Examination description (well-established procedures) 
NA 
ii. 
Total number of times each procedure will be performed (typical study participant) 
NA 
iii. 
Setup and techniques to support dose modeling 
NA 
iv. 
FDA status of the machine and information on dose modeling (if procedure is not 
well-established) 
NA 
d. 
Radiation Machines – Therapeutic Procedures 
i. 
Area treated, dose per fraction/number of fractions, performed as part of normal 
clinical management or due to research participation (well-established procedures) 
NA 
ii. 
FDA status of the machine, basis for dosimetry, area treated, dose per fraction and 
number of fractions (if procedure is not well-established) 
NA 
5. 
DEVICES USED IN THE STUDY 
a. 
Investigational Devices (Including Commercial Devices Used Off-Label) 
Investigational Device 1 
Name: 
             NA 

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Description: 
NA 
Significant Risk? (Y/N) 
NA 
Rationale for Non-
Significant Risk 
NA 
Investigational Device 2 
Name: 
NA 
Description: 
NA 
Significant Risk? (Y/N) 
NA 
Rationale for Non-
Significant Risk 
NA 
Investigational Device 3 
Name: 
NA 
Description: 
NA 
Significant Risk? (Y/N) 
NA 
Rationale for Non-
Significant Risk 
NA 
 
b. 
IDE-Exempt Devices 
IND-Exempt Device 1 
Name: 
NA 
Description: 
NA 
IND-Exempt Device 2 
Name: 
NA 
Description: 
NA 
IND-Exempt Device 3 
Name: 
NA 
Description: 
NA 
 
6. 
DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY 
a. 
Investigational Drugs, Biologics, Reagents, or Chemicals 
Investigational Product 1 
Name: 
NA 
Dosage: 
NA 
Administration Route: 
NA 
Investigational Product 2 
Name: 
NA 
Dosage: 
NA 
Administration Route: 
NA 
Investigational Product 3 
Name: 
NA 
Dosage: 
NA 
Administration Route: 
NA 
b. 
Commercial Drugs, Biologics, Reagents, or Chemicals 
Commercial Product 1 

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Name: 
NA 
Dosage: 
NA 
Administration Route 
NA 
New and different use? 
(Y/N) 
             NA 
Commercial Product 2 
Name: 
NA 
Dosage: 
NA 
Administration Route 
NA 
New and different use? 
(Y/N) 
NA 
Commercial Product 3 
Name: 
NA 
Dosage: 
NA 
Administration Route 
NA 
New and different use? 
(Y/N) 
             NA 
7. 
DISINFECTION PROCEDURES FOR MEDICAL EQUIPMENT USED ON BOTH HUMANS AND 
ANIMALS 
NA 
 
8. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
(i) In total, up to 315 participants may be enrolled.  
(ii) 75 participants may be enrolled at the VA and 240 at Stanford.  
(iii) Patients and veterans undergoing surgery will be recruited as we are studying a 
preoperative psychoeducational intervention. 
b. 
Age, Gender, and Ethnic Background 
Patients 18 years of age or older, of both genders, and all ethnic backgrounds will be 
recruited 
 
c. 
Vulnerable Populations 
NA 
d. 
Rationale for Exclusion of Certain Populations 
NA 
e. 
Stanford Populations 
We will not recruit specifically among laboratory personnel, employees, and/or students, 
however it is possible some may be enrolled in the study. They will undergo the same 
informed consent process as all other patients 

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f. 
Healthy Volunteers 
NA 
g. 
Recruitment Details 
Participants will be identified from the pre-operative appointments at Stanford and at the 
VA hospital. They may be recruited via referrals from clinic personnel or when a member 
of the research team, when present at the clinic, approaches relevant patients either before 
or after their scheduled appointment. Patients may self-refer through responses to 
advertisements, or via the clinical trials website, which will be open to the general public, 
if the patient is scheduled to receive surgery at Stanford or the VA hospital. Recruitment 
will be open to all patients scheduled for an eligible surgical procedure. Patients willing 
to be spoken with regarding the research will be approached by a member of the research 
team during their appointment, or will be called by the research team to discuss the study 
further.  
 
If the patient indicates they do not wish to participate in the research study, they may be 
asked if it is ok for us to collect some anonymous information about them so that we 
know how they may differ from patients who choose to participate in the study. The 
anonymous data collection form (attached to section 13 with waiver of documentation for 
consent) will be filled out by the research staff and the research staff will first inform 
patients on the 8 elements of consent prior to asking for the anonymous data. The 
informational sheet script is attached to the anonymous data collection form. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
1. Age 18+  
2. Undergoing a scheduled surgery  
3. English speaking  
4. Ability and willingness to complete study procedures including online 
questionnaires, assessments, and the psychoeducational video. 
ii. 
Exclusion Criteria 
1. Any conditions causing inability to complete study procedures (e.g. education, 
cognitive ability, mental status, medical status) or lack of access to internet and phone 
that would prevent participation in study procedures - at the discretion of the 
investigator.  
2. Known Pregnancy  
3. Ongoing legal action related to pain or disability claim. 
 
i. 
Screening Procedures 
Patients will be identified through their response to a form given to them at a pre-operative visit 
requesting contact information if they are interested in hearing more about the study, or through 

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their clinic provider requesting permission for the research team to speak with them. Further 
phone screening or in-person screening at the pre-operative appointment will occur to determine 
initial eligibility. We are seeking a limited waiver of authorization for recruitment to obtain the 
names, contact information, date of surgery, and eligibility information of patients prior to 
obtaining informed consent. No qualifying laboratory values will be obtained. After screening for 
eligibility, informed consent will be obtained from eligible participants. 
 
j. 
Participation in Multiple Protocols 
Patients will be asked whether they are participating in any other research studies. Those 
participating in other studies that may interfere with the procedures of this study, or pose 
additional risk, will be excluded. 
k. 
Payments to Participants 
Participants will not receive payment for their participation 
l. 
Costs to Participants 
There will be no costs charged to the participant. 
 
m. 
Planned Duration of the Study 
We anticipate completing enrollment in 2 years. However data will continue to be 
collected and reported intermittently over years. We plan to continue to asses patients for 
pain, medication use, and medical status every 6 months up to 10 years.  
 
(i) total time for screening will be approximately 1 hour  
(ii) median time of active participation is roughly 90 days  
(iii) analysis of participant data will take several months 
9. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
NA 
ii. 
Investigational drugs 
NA 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
NA 
iv. 
Procedures 
NA 
v. 
Radioisotopes/radiation-producing machines 

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NA 
vi. 
Physical well-being 
NA 
vii. 
Psychological well-being 
There are no known risks to completing the study questionnaires. There is a chance some 
patients may feel uncomfortable answering certain questions and they have the option to 
refuse to answer certain questions. We may administer the BDI or PROMIS Depression 
to participants and their responses may indicate suicidality and depression. Patients 
exhibiting signs of depression will be provided with a referral list of mental health 
providers. Patients endorsing suicidality by answering 2 or greater on the BDI suicidality 
question will be offered immediate assessment. 
viii. 
Economic well-being 
NA 
ix. 
Social well-being 
NA 
x. 
Overall evaluation of risk 
LOW 
b. 
International Research Risk Procedures 
NA 
c. 
Procedures to Minimize Risk 
Risks of discomfort due to the questionnaires will be minimized by allowing the 
participant to refuse to answer particular questions.  
 
PHI will be kept in a secure location accessible only to study staff. Electronic data will be 
kept on a password protected and encrypted computer accessible only to study staff. All 
research personnel are trained in confidentiality and protection of PHI. 
d. 
Study Conclusion 
The experiment will terminate when all participants have completed participation. If an 
individual participant chooses to withdraw, or the researcher determines it is unsafe or 
scientifically invalid for him/her to continue, his/her participation will end. We do not 
anticipate the study will directly result in adverse effects to the participants but we have 
physicians on staff should a medical intervention become necessary in the event of an 
adverse event. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 

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NA 
ii. 
Person(s) responsible for Data and Safety Monitoring 
NA 
iii. 
Frequency of DSMB meetings 
NA 
iv. 
Specific triggers or stopping rules 
NA 
v. 
DSMB Reporting 
NA 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
Y 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
Y 
f. 
Risks to Special Populations 
NA 
10. 
BENEFITS 
We cannot guarantee personal benefit to any participant. Participants in the observational study 
will receive no direct benefit for their participation. However, participants in the intervention arm 
may experience a reduction in pain catastrophizing, as a result of viewing the educational 
video. Coping skills learned from the video may aid recovery from surgery. 
11. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.