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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05429970
Status
Recruiting
Apply to this trial

Conditions

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Stage II Fallopian Tube Cancer
  • Stage II Ovarian Cancer
  • Stage II Ovary Cancer
  • Stage III Fallopian Tube Cancer
  • Stage III Ovarian Cancer
  • Stage III Ovary Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Ovary Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mind-body resilience training — BEHAVIORAL
    MBRT is a meditation technique used to achieve relaxation)
  • Music therapy — BEHAVIORAL
    Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
  • Propranolol — DRUG
    Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
  • Etodolac — DRUG
    Etodolac 400 mg PO BID (for 21 consecutive days)

Study Details

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

Key Dates

Start date
Jun 17, 2022
Status verified
May 2026
Primary completion
Jun 17, 2026
Completion
Jun 17, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PSRB
    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.
  • No Intervention: Standard of Care
    Participants will receive usual care (study interventions not specifically recommended)

Primary Outcome Measure

Number of participants successfully completing over 80% of the bundled interventions [ Time Frame: 21 days after surgical procedure ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)CommackNew York11725
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Kara Long Roche, MD
646-608-3787
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Kara Long Roche, MD
646-608-3787

Find similar trials in Basking Ridge, NJ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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