Opioid Education for Post-Surgery in Breast Cancer

(SAVE Trial)

Overseen By Ethan Lester

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Chronic opioid use, Chronic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a short educational video about safe opioid use helps breast reconstruction patients manage their post-surgery pain medication more effectively. The video covers the opioid crisis, safe opioid use, and proper disposal. Participants will be divided into two groups: one will watch the video, while the other will receive standard care without it. Women undergoing breast reconstruction surgery using tissue from their abdomen after a mastectomy are ideal candidates for this study. The goal is to improve opioid prescribing and usage after surgery, potentially benefiting other surgical areas in the future. As an unphased trial, this study allows patients to contribute to important research that could enhance post-surgical care practices.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on educating about opioid use after surgery.

What prior data suggests that this educational intervention is safe?

Research has shown that watching an educational video about opioids is safe. Participants in this study will watch a video, which is neither a drug nor a medical treatment, and thus has no physical side effects. The video aims to educate about the use and disposal of opioids. This method is expected to be manageable, as it solely provides information without altering medication or introducing new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the opioid educational video because it offers a fresh approach to managing opioid use in post-surgery breast cancer patients. Unlike traditional care, which primarily relies on prescribing medications and providing written guidelines, this video aims to educate patients through a short, easily understandable video format before surgery. By enhancing patient understanding of proper opioid use, the video could help reduce the risk of misuse and improve pain management, potentially leading to better overall outcomes and a more informed patient experience.

What evidence suggests that this opioid educational video is effective for post-surgery in breast cancer?

Research has shown that educational videos about safe opioid use can help patients take fewer opioids after surgery. In this trial, participants in the "Opioid Video" arm will watch a 3-minute educational video on proper opioid use before surgery. One study found that teaching patients how to use opioids correctly led to less opioid use in breast reconstruction patients. Another study demonstrated that digital education could help manage pain and reduce the need for opioids after breast cancer surgery. By informing patients about the opioid crisis and how to use and dispose of opioids safely, these videos aim to prevent long-term opioid use. This method could lead to new guidelines for prescribing opioids after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Jay Agarwal, MD

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Are You a Good Fit for This Trial?

The SAVE Trial is for patients undergoing breast reconstruction after breast cancer who will be prescribed opioids post-surgery. Participants must be willing to watch an educational video about opioid use and disposal. Specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

I am having breast reconstruction with my own tissue after a mastectomy.

I am a woman aged 18 or older.

Exclusion Criteria

I am having a mastectomy and immediate reconstruction.

I am having a breast reconstruction with my own tissue after a failed implant surgery.

I have been using opioids long-term for a chronic pain condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Education

Participants in the opioid video cohort watch a 3-minute education video on proper opioid use preoperatively

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for opioid consumption and complications post-discharge

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Opioid Educational Video

Trial Overview This trial tests the effectiveness of a video educating patients on safe opioid use versus standard care without targeted education. It's a randomized controlled study at one institution, aiming to influence opioid prescribing practices based on patient usage data.

How Is the Trial Designed?

Group I: Opioid Video Experimental Treatment 1 Intervention

Patients in the opioid video cohort will watch a 3-minute education video on proper opioid use preoperatively. All patients who consent to study participation will be given the same surgical care and inpatient intraoperative and postoperative analgesic regimen regardless of cohort allocation.

Group II: Regular Care Active Control 1 Intervention

All patients who consent to study participation will be given the same surgical care and inpatient intraoperative and postoperative analgesic regimen regardless of cohort allocation.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07044583

SAVE Trial: SAfe Opioid Use Video Education In the breast reconstruction after mastectomy population, studies report as many as 47% of patients go on to become prolonged users of opioids. The primary goal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6830264/

“My Surgical Success”: Effect of a Digital Behavioral Pain ... This study aims to assess the feasibility of digital perioperative behavioral pain medicine intervention in breast cancer surgery and evaluate ...

3. ancora.ai ancora.ai/en/details/NCT07044583

SAVE Trial: SAfe Opioid Use Video Education This outcome measure will report the percentage of opioids prescribed consumed from breast reconstruction surgery up to 2 weeks. Non-Opioid ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-7-2025-269f7

Opioid Education for Post-Surgery in Breast Cancer (SAVE ... The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid epidemic, ...

5. link.springer.com link.springer.com/article/10.1245/s10434-018-6772-3

The Impact of Education and Prescribing Guidelines on ... For breast biopsy or lumpectomy, 137 patients (27%) underwent surgery before the intervention and 370 patients (73%) underwent surgery after the ...

6. ctv.veeva.com ctv.veeva.com/study/save-trial-safe-opioid-use-video-education-a-randomized-control-trial

SAVE Trial: SAfe Opioid Use Video Education The study will assess the efficacy of a standardized postoperative patient-centered intervention designed to educate patients on the opioid ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7543235/

Prolonged Opioid Use After Surgery for Early‐Stage Breast ... This study examined the patterns of prolonged opioid use and the factors associated with higher risk of prolonged opioid use among ...

8. qualitysafety.bmj.com qualitysafety.bmj.com/content/34/3/166

Decoding behaviour change techniques in opioid ... Engaging education about risks of opioid use with patients before elective surgery of the lower extremity did not reduce postoperative opioid utilization: a ...