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Self-Hypnosis for the Enhanced Recovery After Surgery in Patients With Gynecologic Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04266886
Collaborator
National Cancer Institute (NCI) (NIH)
224
Enrollment
1
Location
2
Arms
36.6
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Procedure: Hypnotherapy
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. 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.

  2. To explore whether participation in pre-operative SH is associated with changes in length of stay.

  3. 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).

  4. To explore whether expectations regarding symptom management or hypnotic susceptibility are related to or influence the perception of symptoms after surgery.

  5. 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:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Integration of Self-Hypnosis in an Enhanced Recovery After Surgery (ERAS) Program: A Prospective Randomized Trial
Actual Study Start Date :
Sep 11, 2018
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (usual care)

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.

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies
    Experimental: Arm II (usual care, self-hypnosis guided relaxation)

    Patients receive usual care as in Arm I. Patients also receive self-hypnosis guided relaxation by listening to MP3 on the ERAS pathway.

    Other: Best Practice
    Receive usual care
    Other Names:
  • standard of care
  • standard therapy

    • Procedure: Hypnotherapy
    Receive self-hypnosis guided relaxation
    Other Names:
  • Clinical Hypnosis
  • Hypnosis

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of participating in pre-operative self-hypnosis [Up to 1 day]

      Will assess proportion of participants who listen to the complete audio file in the preoperative holding area.

    2. Patients' perception of post-surgical pain [Post-operative day 1 (POD1)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Larissa A Meyer, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04266886
    Other Study ID Numbers:
    • 2018-0143
    • NCI-2019-08222
    • 2018-0143
    First Posted:
    Feb 12, 2020
    Last Update Posted:
    Nov 2, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Genital Neoplasms, Female

    Study Results

    No Results Posted as of Nov 2, 2020