RECRUITING

Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

Official Title

Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Quick Facts

Study Start:2023-10-12

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05766891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and Women; 2. Age 18 or older; 3. Diagnosed with stage 0/1 BCa; 4. Scheduled for a unilateral, segmental mastectomy ± SLND 5. Able to read, write and speak English or Spanish 6. Able to sign a written informed consent and be willing to follow protocol requirements.	1. Extreme mobility issues that preclude participating in the study 2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD; 3. Low score on Tellegen Absorption Scale (10 or below, a correlate of hypnotic suggestibility) 4. History of chronic opioid use 5. Current pain 2 or above on 0-10 scale 6. Co-mobilities such as uncontrollable diabetes or hypertension 7. Plastic surgery involvement for oncoplastic reconstruction 8. Have undergone chemotherapy for current breast cancer diagnosis 9. Surgery is likely greater than 3 hours 10. Patients with hearing loss that could preclude HS facilitation 11. Known allergy to propofol or other medications used during surgery

Inclusion Criteria

Exclusion Criteria

1. Men and Women;
2. Age 18 or older;
3. Diagnosed with stage 0/1 BCa;
4. Scheduled for a unilateral, segmental mastectomy ± SLND
5. Able to read, write and speak English or Spanish
6. Able to sign a written informed consent and be willing to follow protocol requirements.

1. Extreme mobility issues that preclude participating in the study
2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD;
3. Low score on Tellegen Absorption Scale (10 or below, a correlate of hypnotic suggestibility)
4. History of chronic opioid use
5. Current pain 2 or above on 0-10 scale
6. Co-mobilities such as uncontrollable diabetes or hypertension
7. Plastic surgery involvement for oncoplastic reconstruction
8. Have undergone chemotherapy for current breast cancer diagnosis
9. Surgery is likely greater than 3 hours
10. Patients with hearing loss that could preclude HS facilitation
11. Known allergy to propofol or other medications used during surgery

Contacts and Locations

Study Contact

Lorenzo Cohen, MD

CONTACT

(713) 745-4260

lcohen@mdanderson.org

Principal Investigator

Lorenzo Cohen, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Lorenzo Cohen, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-10-12

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer