Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Behavioral: Psychoeducational My Surgical Success Video

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting