35 Participants Needed

Stress Reduction Therapies for Ovarian Cancer

Recruiting at 8 trial locations
KL
AA
Overseen ByAnoushka Afonso, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: β-blockers, COX2 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take any β-blockers or COX inhibitors, as chronic treatment with these medications is an exclusion criterion. If you are currently on these medications, you would need to stop taking them to participate in the trial.

What data supports the effectiveness of the treatment for stress reduction in ovarian cancer patients?

Research shows that music therapy, a component of the treatment, can effectively reduce stress, anxiety, and pain in cancer patients, improving their mood and overall well-being during treatment.12345

Is music therapy safe for humans?

Music therapy is generally considered safe and can be beneficial for various physical, emotional, and psychological needs. It is used as an adjunct therapy in many medical settings and has been shown to help with stress, anxiety, and other symptoms without replacing traditional medical treatments.46789

How does music therapy differ from other treatments for ovarian cancer?

Music therapy is unique because it uses music to help reduce stress, anxiety, and improve mood, which can be particularly beneficial for cancer patients. Unlike traditional medical treatments, it involves active or passive participation in music sessions led by a trained therapist, focusing on emotional and psychological support rather than directly targeting the cancer itself.1351011

What is the purpose of this trial?

This trial tests if propranolol, etodolac, MBRT, and music therapy can reduce stress in patients having major surgeries. These treatments aim to lower anxiety, pain, and promote relaxation. Propranolol has been found to reduce anxiety in various medical settings, including day case surgery.

Research Team

KL

Kara Long Roche, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I understand the study's goals, can follow the rules, and agree to participate.
I am scheduled for surgery to examine my abdomen and remove as much cancer as possible.
I have advanced ovarian, fallopian tube, or peritoneal cancer.
See 2 more

Exclusion Criteria

I am on long-term medication for heart issues or pain that includes β-blockers or COX inhibitors.
I am undergoing a minimally invasive procedure.
I cannot take β-blockers due to certain health conditions like asthma or heart issues.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants receive mind-body resilience training/MBRT, music therapy, propranolol, and etodolac before surgery

1 week
1 visit (in-person)

Surgical Procedure

Participants undergo primary debulking surgery (PDS) or interval debulking surgery (IDS)

1 day
1 visit (in-person)

Postoperative Intervention

Participants receive postoperative mind-body resilience training/MBRT, music therapy, propranolol, and etodolac

7 days
Daily visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 days

Treatment Details

Interventions

  • Etodolac
  • Mind-body Resilience Training
  • Music Therapy
  • Propranolol
Trial Overview 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.
Participant Groups
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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.
Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.
Music therapy in supportive cancer care.Stanczyk, MM.[2022]
Music therapy, including the Bonny Method of Guided Imagery and Music (GIM), has been used across cultures for healing various ailments such as pain, cancer, depression, and PTSD, highlighting its broad therapeutic potential.
The article reviews the research supporting GIM therapy and includes a personal account of the treatment experience, emphasizing its effectiveness and the emotional impact of music in therapy.
Guided imagery and music: using the Bonny method to evoke emotion and access the unconscious.Beebe, LH., Wyatt, TH.[2022]
Music therapy, led by credentialed therapists, is an effective complementary treatment in oncology that helps reduce stress, anxiety, pain, and nausea in patients.
The therapy is tailored to individual patient needs and can involve active or passive participation, ensuring safety and promoting positive clinical outcomes.
Music therapy: a valuable adjunct in the oncology setting.Mahon, EM., Mahon, SM.[2011]

References

Music therapy in supportive cancer care. [2022]
Guided imagery and music: using the Bonny method to evoke emotion and access the unconscious. [2022]
Music therapy: a valuable adjunct in the oncology setting. [2011]
Music therapy research and applications in pediatric oncology treatment. [2017]
Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. [2015]
[Music therapy and internal medicine]. [2006]
Music therapy for dementia symptoms. [2020]
Integrative Music Therapy: A Healing Intervention. [2019]
[Regulative music therapy and training as a means for enhancing adaptive potentials and for overcoming fatigue and stress]. [2008]
Interactive Music Therapy on Stress Level Reduction in Women Submitted to IVF/ICSI. Prospective Randomized Study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. [2023]
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