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

NCT03076190 | Completed Results

• 1 other identifier: 30340
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

psychology; pain; surgery; treatment; catastrophizing; cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately post-treatment

Secondary Outcomes (1)

• Group Difference in Within-subject Pain Catastrophizing

  Before surgery to post-surgically

Other Outcomes (3)

• Group Difference in Time to Opioid Cessation

  Data on opioid use was collected for the 4 month duration of the study

• Group Difference in Post-surgical PROMIS Physical Function and PROMIS Pain Interference

  From baseline to post-surgery (up to 4 months duration of the study)

• Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)

  Baseline

Study Arms (2)

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)

Behavioral: Psychoeducational My Surgical Success Video

Interventions

Psychoeducational My Surgical Success Video BEHAVIORAL

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.

My Surgical Success Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Related Publications (1)

• 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.

  PMID: 31087093 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample was underpowered to detect medium effects; Populations with pre-existing pain may better engage in a treatment to address a relevant problem; The study sample was women undergoing surgery for breast cancer, which limits generalizability.

Results Point of Contact

• Title: Dr. Beth Darnall
• Organization: Stanford University

bdarnall@stanford.edu

6507365494

Study Officials

• Beth D Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: March 10, 2017
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 22, 2024
• Results First Posted: April 1, 2020

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share