CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Psychoeducational My Surgical Success Videobehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03076190
NCT03076190N/ACompleted

Feasibility and Preliminary Efficacy of an Internet-based Pre-surgical Pain Psychology Intervention: A Randomized Controlled Pilot Study of "My Surgical Success"

Stanford University·interventional·Posted Mar 10, 2017·Updated Apr 22, 2024

In Brief

A clinical study evaluating Psychoeducational My Surgical Success Video for Breast Cancer. Completed, enrolled 131 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 10, 2017
Enrollment StartAug 1, 2015
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.3 years ago

Interventions

Psychoeducational My Surgical Success Videobehavioral

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.