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

NCT03076190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2024-04-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Beth D Darnall, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-06-30
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076190 on ClinicalTrials.gov