My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03076190|
Recruitment Status : Completed
First Posted : March 10, 2017
Results First Posted : April 1, 2020
Last Update Posted : April 1, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Psychoeducational My Surgical Success Video||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Preliminary Efficacy of an Internet-based Pre-surgical Pain Psychology Intervention: A Randomized Controlled Pilot Study of "My Surgical Success"|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
No Intervention: Active Control Group (Health Education)
Prior to surgery:
Experimental: My Surgical Success Treatment Group
Prior to surgery:
Behavioral: Psychoeducational My Surgical Success Video
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.
- 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.
- Group Difference in Within-subject Pain Catastrophizing [ Time Frame: Before surgery to post-surgically ]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.
- Group Difference in Time to Opioid Cessation [ Time Frame: Data on opioid use was collected for the 4 month duration of the study ]Postsurgical opioid stop date was self-reported by patients. The opioid stop date was collected through the two-, four-, eight-, and 12-week follow-up surveys with the question "On what date did you stop taking your opioid medication?" The number of postsurgical days using opioids was calculated by subtracting the opioid stop date from the surgery date obtained in the medical chart. Statistical analyses present the data in mean number of days to opioid cessation in each group.
- Group Difference in Post-surgical PROMIS Physical Function and PROMIS Pain Interference [ Time Frame: From baseline to post-surgery (up to 4 months duration of the study) ]PROMIS scores for physical function and pain interference will be reported post-surgically. All PROMIS assessments were converted from raw scores to t-scores (Mean= 50, SD=10). Higher scores on PROMIS pain interference signify greater severity of pain interfering with patient's functioning. However, higher scores on Physical function reflects a greater level of physical functioning. The investigators will conduct within subject analyses and will report pre-post treatment changes.
- Characterize Responders to My Surgical Success (Demographics and Psychological Correlates) [ Time Frame: Baseline ]The investigators will report the baseline psychosocial scores (PROMIS measures) for patients who report high satisfaction with the My Surgical Success treatment. Pain Intensity Scale ranges from 0 (no Pain) to 10 (the worst pain imaginable), with higher scores indicating worse pain. Total scores range from 0-10. Pain Catastrophizing Scale is a 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. All PROMIS assessments were converted from raw scores to t-scores (M= 50, SD=10). There are no minimum and maximum values as these are standardized scores. PROMIS Pain Intensity, Pain Interference, Physical Function, Depression, Anxiety, were administered at baseline. Higher scores on PROMIS depression, anxiety, pain interference, and pain intensity signify greater severity of these symptoms. However, higher scores on Physical Function reflects a greater level of physical functioning.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076190
|Principal Investigator:||Beth D Darnall, PhD||Stanford University|