Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer
Primary Purpose
Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Hypnotherapy
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Malignant Female Reproductive System Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
- Planned participation in the Gynecologic Enhanced Recovery Pathway
- Patient must be able to read, understand, and speak English
- Consents to being part of a randomized study
- Patient has physical and mental capabilities to take part in study
Exclusion Criteria:
- Sensitivity to amide-type local anesthetics
- Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
- Emergency surgery of any type that does not allow for proper time for protocol review by the patient
- Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
- Patients undergoing known/anticipated anterior abdominal wall hernia repairs
- Patients undergoing pelvic exenteration
- Patients with known major psychiatric disease
- Patients with hearing impairment such that they are unable to hear the intervention
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I (usual care)
Arm II (usual care, self-hypnosis guided relaxation)
Arm Description
Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway.
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
Outcomes
Primary Outcome Measures
Feasibility of participating in pre-operative self-hypnosis
Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.
Patients' perception of post-surgical pain
Will summarize POD1 pain scores for each treatment arm using descriptive statistics. Will use a Wilcoxon rank sums test to determine if the POD1 pain scores in the self-hypnosis arm are lower than the usual care arm. Pain intensity score from 0 to 10.
Secondary Outcome Measures
Full Information
NCT ID
NCT04266886
First Posted
December 30, 2019
Last Updated
September 18, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04266886
Brief Title
Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer
Official Title
Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial studies how well self-hypnosis works in enhancing recovery after surgery in patients with gynecologic cancer. A guided relaxation method called self-hypnosis may help affect how patients feel pain and symptoms after surgery.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate whether participation in pre-operative self-hypnosis (SH) is feasible and will improve patients' perception of post-surgical pain, after undergoing open gynecologic surgery (laparotomy) on an enhanced recovery pathway.
SECONDARY OBJECTIVES:
I. To evaluate whether participation in pre-operative SH is associated with changes in use of opioid medication, including time to first postoperative opioid and total dose of opioids taken (converted to morphine equivalents) and avoidance of opioids.
II. To explore whether participation in pre-operative SH is associated with changes in length of stay.
III. To explore whether there are differences between the two study arms in other common symptoms of women undergoing gynecologic surgery, functional recovery after surgery and quality of life (QOL).
IV. To explore whether expectations regarding symptom management or hypnotic susceptibility are related to or influence the perception of symptoms after surgery.
V. To measure satisfaction with the intervention (patients on arm 2). VI. To perform sub analyses to explore whether other common clinical or demographic factors are potential covariates.
EXPLORATORY OBJECTIVE:
I. To compare two different instruments measuring patient reported outcomes in hospital postoperative recovery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the enhanced recovery after surgery (ERAS) pathway.
ARM II: Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Metastatic Cervical Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive usual care including receipt of multi-modal analgesia and the injection of a local analgesic at the time of surgery on the ERAS pathway.
Arm Title
Arm II (usual care, self-hypnosis guided relaxation)
Arm Type
Experimental
Arm Description
Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Procedure
Intervention Name(s)
Hypnotherapy
Other Intervention Name(s)
Clinical Hypnosis, Hypnosis
Intervention Description
Receive self-hypnosis guided relaxation
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of participating in pre-operative self-hypnosis
Description
Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.
Time Frame
Up to 1 day
Title
Patients' perception of post-surgical pain
Description
Will summarize POD1 pain scores for each treatment arm using descriptive statistics. Will use a Wilcoxon rank sums test to determine if the POD1 pain scores in the self-hypnosis arm are lower than the usual care arm. Pain intensity score from 0 to 10.
Time Frame
Post-operative day 1 (POD1)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
Planned participation in the Gynecologic Enhanced Recovery Pathway
Patient must be able to read, understand, and speak English
Consents to being part of a randomized study
Patient has physical and mental capabilities to take part in study
Exclusion Criteria:
Sensitivity to amide-type local anesthetics
Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
Emergency surgery of any type that does not allow for proper time for protocol review by the patient
Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
Patients undergoing known/anticipated anterior abdominal wall hernia repairs
Patients undergoing pelvic exenteration
Patients with known major psychiatric disease
Patients with hearing impairment such that they are unable to hear the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa A Meyer
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer
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