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Stress Reduction Therapies for Ovarian Cancer

N/A

Recruiting

Led By Kara Long Roche, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent

Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days after surgical procedure

Awards & highlights

Study Summary

This trial is testing if a combination of drugs and therapies can help reduce stress for people undergoing surgery.

Who is the study for?

This trial is for adults over 18 with advanced ovarian, fallopian tube, or peritoneal carcinoma who are scheduled for surgery. Participants must understand the study and consent to it. Exclusions include active infections, pregnancy, chronic autoimmune diseases, other clinical trial participation that conflicts with this one, and certain medical conditions like asthma or liver failure.Check my eligibility

What is being tested?

The PRESERVE study tests if propranolol and etodolac combined with mind-body resilience training and music therapy can reduce stress in patients undergoing surgery for ovarian cancer better than standard care without these interventions.See study design

What are the potential side effects?

Possible side effects may include reactions to propofol such as drowsiness or nausea; etodolac could cause stomach issues or headaches; mind-body training is generally safe but might bring up emotional discomfort; music therapy is typically risk-free.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study's goals, can follow the rules, and agree to participate.

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I have advanced ovarian, fallopian tube, or peritoneal cancer.

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I am 18 years old or older.

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I am scheduled for surgery to examine my abdomen and remove as much cancer as possible.

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My health is good to moderately impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days after surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days after surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days after surgical procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants successfully completing over 80% of the bundled interventions

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PSRBExperimental Treatment4 Interventions

Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.

Group II: Standard of CareActive Control1 Intervention

Participants will receive usual care (study interventions not specifically recommended)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propofol

2017

Completed Phase 4

~1530

Etodolac

2012

Completed Phase 4

~730

Music therapy

2016

Completed Phase 4

~1220

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,935 Previous Clinical Trials

588,831 Total Patients Enrolled

72 Trials studying Ovarian Cancer

42,938 Patients Enrolled for Ovarian Cancer

Kara Long Roche, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

400 Total Patients Enrolled

Media Library

Mind-body resilience training Clinical Trial Eligibility Overview. Trial Name: NCT05429970 — N/A

Ovarian Cancer Research Study Groups: PSRB, Standard of Care

Ovarian Cancer Clinical Trial 2023: Mind-body resilience training Highlights & Side Effects. Trial Name: NCT05429970 — N/A

Mind-body resilience training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429970 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov states that this medical investigation is actively seeking out volunteers, commencing from June 17th 2022 and most recently updated on September 21st 2022. 30 participants are required for the trial to be held in 7 separate facilities."

Answered by AI

Are any more participants being accepted at this moment for the clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this medical trial was posted on June 17th 2022 and is actively recruiting patients across seven different sites with a goal of 30 enrollees."

Answered by AI

In what areas is this clinical experiment conducted?

"This clinical trial is recruiting from seven distinct centres, including Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) in Basking Ridge, Montvale's Memorial Sloan Kettering Bergen( Limited Protocol Activities), and the esteemed New york-based Memorial Sloan Kettering Cancer Centre (All Protocol Activities). There are also four additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

2022. "A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429970.

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