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My Surgical Success: A Randomized Controlled Pilot Study of a Pre-surgical Psychological Intervention

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ClinicalTrials.gov Identifier: NCT03076190
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Beth Darnall, Stanford University

Brief 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).

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Active Control Group (Health Education)

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)
Experimental: My Surgical Success Treatment Group

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)
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.




Primary Outcome Measures :
  1. Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only) [ 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). Percentages will be reported for each item.


Secondary Outcome Measures :
  1. Group difference in within-subject PCS [ Time Frame: Before surgery ]

Other Outcome Measures:
  1. Group difference in time to pain and opioid cessation [ Time Frame: This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery. ]
  2. Group difference in post-surgical PROMIS function and PROMIS pain interference [ Time Frame: Post-surgical month 1 ]
    PROMIS scores for function and pain interference will be reported at month 1. The investigators will conduct within subject analyses and will report pre-post treatment changes. Also, the investigators will aggregate scores by group and conduct between group analyses to report differences between group means and SD.

  3. Characterize responders to My Surgical Success (demographics and psychological correlates) [ Time Frame: Baseline ]
    The investigators will report the baseline demographic and psychosocial scores for patients who report high satisfaction with the My Surgical Success treatment, as well as those who evidence 30% reduction in PCS scores prior to surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+
  • Scheduled for breast cancer surgery
  • English speaking
  • Ability and willingness to complete study procedures including online questionnaires, assessments, and the psychoeducational video

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Beth D Darnall, PhD Stanford University

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Responsible Party: Beth Darnall, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03076190     History of Changes
Other Study ID Numbers: 30340
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Beth Darnall, Stanford University:
psychology
pain
surgery
treatment
catastrophizing
cancer