Breast CancerNCT03076190
My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention
A study testing Psychoeducational My Surgical Success Video in people with Breast Cancer, run by Stanford University.
Trial summary
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a remote, Internet-based, pre-surgical psychoeducational intervention delivered to patients scheduled for breast cancer surgery (compared to an active control group that receives health education). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychoeducational My Surgical Success Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Scheduled for breast cancer surgery
- English speaking
- Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video
Who cannot join
- 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.
- Known pregnancy
- Ongoing legal action related to pain or disability claim
About this study
Official title: Feasibility and Preliminary Efficacy of an Internet-based Pre-surgical Pain Psychology Intervention: A Randomized Controlled Pilot Study of "My Surgical Success"
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a remote, Internet-based, pre-surgical psychoeducational intervention delivered to patients scheduled for breast cancer surgery (compared to an active control group that receives health education).
Aim 1: Determine feasibility, satisfaction, and perceived utility of My Surgical Success.
Read more
Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success we expect 80% satisfaction ratings, and 80% perceived utility of the information learned.
Aim 2: Determine group differences in within-subject pain catastrophizing scores (baseline - 0 to 48 hours before surgery).
Hypothesis 2: My Surgical Success participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group.
Aim 3: Determine group differences in time to post-surgical pain and opioid cessation.
Hypothesis 3: My Surgical Success participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group.
Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Sleep Related Impairment, Anger, Fatigue, Global, Distress, and Pain Intensity).
Hypothesis 4: My Surgical Success participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group.
The goal of this research is to advance our understanding regarding the feasibility and effectiveness of remote psychoeducation interventions and impact on post-surgical outcomes.
Read the detailed description
Pre-surgical patients are identified by their breast surgeon. The entire study is conducted remotely with no in-person contact with study staff. Study staff call patients and invite them to enroll in the study; informed consent is obtained online.
All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, self-efficacy, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap).
Participants are then randomized to either the Internet-based pain psychology intervention (My Surgical Success) or to brief online health education (HE Control). Prior to surgery, participants who have been randomized to the HE control group will receive patient handouts online about health and nutrition and are oriented that the information is relevant for improving recovery from surgery. The Internet-based pain psychology intervention emphasizes treatment content that targets pain catastrophizing. My Surgical Success includes a psychoeducational video, a downloadable audio file, and a downloadable PDF Personalized Plan for Success. After viewing the online treatment video, participants randomized to My Surgical Success complete questions regarding participant satisfaction with the video, perceived usefulness of information, and likelihood to use the skills learned. Pain catastrophizing scores are collected from all study participants prior to surgery. All participants are tracked daily post-surgically to assess pain, opioid use, distress, and use of skills learned from treatment; data are captured daily for 30 days, then weekly for 2 weeks, then every 2 weeks for 4 weeks to pain and opioid cessation (or the end of 12 weeks). Psychosocial data are collected post-surgically at weeks 2, 4, 8, and 12.
Post-treatment questions:
Participants in the My Surgical Success group complete the following questions at the end of the video: how understandable the video was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the video.
Participants in HE Control are asked how understandable the health information packet was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the packet.
The pain catastrophizing scale (PCS) is administered following treatment and before surgery to all participants.
Following surgery, all participants fill out online daily measures to assess pain and medication use. Daily measures continue until the participant reports 3 consecutive reports of zero average pain and zero opiate use and has indicated they have recovered from surgery. Until reaching this endpoint, daily measures are collected for 30 days, then bi-weekly for an additional 2 weeks, and then weekly for a period of between 2-6 additional weeks.
- Conditions
- Breast Cancer
- Being tested
- Psychoeducational My Surgical Success Video
- Keywords
- psychology, pain, surgery, treatment, catastrophizing, cancer
- Medical subject headings
- Breast Neoplasms, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational My Surgical Success VideoBehavioural
The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Active Control Group (Health Education) | No intervention | Prior to surgery: * Demographics survey * Baseline surveys * Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery. * Follow-up questions about the handouts (detailed above) Post-surgery: * Daily surveys (detailed above) * Follow-up surveys (2, 4, 8, and 12 weeks after surgery) |
| My Surgical Success Treatment Group | Experimental | Prior to surgery:
* Demographics survey
* Baseline surveys
* Intervention:
* 90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment.
* audio file
* personalized plan that incorporates the information learned in the video.
* Follow-up questions about the video (detailed above)
Post-surgery:
* Daily surveys (detailed above)
* Follow-up surveys (2, 4, 8, and 12 weeks after surgery) Receives: Behavioral: Psychoeducational My Surgical Success Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.
Measured: Immediately post-treatment
Secondary outcomes (1)
Group Difference in Within-subject Pain Catastrophizing
Pain Catastrophizing Scale is a validated 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. Data below presents total scores on the scale.
Measured: Before surgery to post-surgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startAug 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
- Investigators
- Beth D Darnall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076190
- Sponsor's protocol ID
- 30340
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2016
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Darnall BD, Ziadni MS, Krishnamurthy P, Flood P, Heathcote LC, Mackey IG, Taub CJ, Wheeler A. "My Surgical Success": Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery-A Pilot Randomized Controlled Clinical Trial. Pain Med. 2019 Nov 1;20(11):2228-2237. doi: 10.1093/pm/pnz094.
PubMed 31087093
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of an Internet-based Pre-surgical Pain Psychology Intervention: A Randomized Controlled Pilot Study of "My Surgical Success"
- ClinicalTrials.gov ID
- NCT03076190
- Acronym / sponsor ID
- 30340
- Conditions
- Breast Cancer
- Keywords
- psychology, pain, surgery, treatment, catastrophizing, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Posted 1 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine the feasibility and preliminary efficacy of a remote, Internet-based, pre-surgical psychoeducational intervention delivered to patients scheduled for breast cancer surgery (compared to an active control group that receives health education).
Aim 1: Determine feasibility, satisfaction, and perceived utility of My Surgical Success.
Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success we expect 80% satisfaction ratings, and 80% perceived utility of the information learned.
Aim 2: Determine group differences in within-subject pain catastrophizing scores (baseline - 0 to 48 hours before surgery).
Hypothesis 2: My Surgical Success participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group.
Aim 3: Determine group differences in time to post-surgical pain and opioid cessation.
Hypothesis 3: My Surgical Success participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group.
Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Sleep Related Impairment, Anger, Fatigue, Global, Distress, and Pain Intensity).
Hypothesis 4: My Surgical Success participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group.
The goal of this research is to advance our understanding regarding the feasibility and effectiveness of remote psychoeducation interventions and impact on post-surgical outcomes.
Detailed description
Pre-surgical patients are identified by their breast surgeon. The entire study is conducted remotely with no in-person contact with study staff. Study staff call patients and invite them to enroll in the study; informed consent is obtained online.
All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, self-efficacy, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap).
Participants are then randomized to either the Internet-based pain psychology intervention (My Surgical Success) or to brief online health education (HE Control). Prior to surgery, participants who have been randomized to the HE control group will receive patient handouts online about health and nutrition and are oriented that the information is relevant for improving recovery from surgery. The Internet-based pain psychology intervention emphasizes treatment content that targets pain catastrophizing. My Surgical Success includes a psychoeducational video, a downloadable audio file, and a downloadable PDF Personalized Plan for Success. After viewing the online treatment video, participants randomized to My Surgical Success complete questions regarding participant satisfaction with the video, perceived usefulness of information, and likelihood to use the skills learned. Pain catastrophizing scores are collected from all study participants prior to surgery. All participants are tracked daily post-surgically to assess pain, opioid use, distress, and use of skills learned from treatment; data are captured daily for 30 days, then weekly for 2 weeks, then every 2 weeks for 4 weeks to pain and opioid cessation (or the end of 12 weeks). Psychosocial data are collected post-surgically at weeks 2, 4, 8, and 12.
Post-treatment questions:
Participants in the My Surgical Success group complete the following questions at the end of the video: how understandable the video was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the video.
Participants in HE Control are asked how understandable the health information packet was, its relevance, usefulness, their satisfaction, how likely they are to use the information, and what they learned from the packet.
The pain catastrophizing scale (PCS) is administered following treatment and before surgery to all participants.
Following surgery, all participants fill out online daily measures to assess pain and medication use. Daily measures continue until the participant reports 3 consecutive reports of zero average pain and zero opiate use and has indicated they have recovered from surgery. Until reaching this endpoint, daily measures are collected for 30 days, then bi-weekly for an additional 2 weeks, and then weekly for a period of between 2-6 additional weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Group (Health Education) | No intervention | –Prior to surgery: * Demographics survey * Baseline surveys * Participants receive online information regarding nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery. * Follow-up questions about the handouts (detailed above) Post-surgery: * Daily surveys (detailed above) * Follow-up surveys (2, 4, 8, and 12 weeks after surgery) |
| My Surgical Success Treatment Group | Experimental | Behavioral: Psychoeducational My Surgical Success VideoPrior to surgery: * Demographics survey * Baseline surveys * Intervention: * 90-minute psychoeducational My Surgical Success video that emphasizes catastrophizing treatment. * audio file * personalized plan that incorporates the information learned in the video. * Follow-up questions about the video (detailed above) Post-surgery: * Daily surveys (detailed above) * Follow-up surveys (2, 4, 8, and 12 weeks after surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Scheduled for breast cancer surgery
- English speaking
- Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video
Key exclusion criteria (3 listed)
- 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.
- Known pregnancy
- Ongoing legal action related to pain or disability claim
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational My Surgical Success VideoThe 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation. | Behavioural | My Surgical Success Treatment Group |
Primary outcome
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning
Time frame: Immediately post-treatment
Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.
1 secondary outcome
Group Difference in Within-subject Pain Catastrophizing
Time frame: Before surgery to post-surgically
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31087093Darnall BD, Ziadni MS, Krishnamurthy P, Flood P, Heathcote LC, Mackey IG, Taub CJ, Wheeler A. "My Surgical Success": Effect of a Digital Behavioral Pain Medicine Intervention on Time to Opioid Cessation After Breast Cancer Surgery-A Pilot Randomized Controlled Clinical Trial. Pain Med. 2019 Nov 1;20(11):2228-2237. doi: 10.1093/pm/pnz094.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth D Darnall, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational My Surgical Success Video in people with Breast Cancer, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning (time frame: Immediately post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.