Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study

The purpose of this study is to compare two hypnotic interventions for Black women with advanced cancer pain in preparation for a well-powered phase III study. The investigators plan to enroll 30 adult Black women with advanced cancer pain in a 2-arm pilot randomized controlled trial (RCT).

The primary aim will be to evaluate the feasibility of conducting the 2-arm clinical trial. It is hypothesized that at least 75% of participants in both study arms will complete study requirements. The secondary aims will be to evaluate the participant's experience with the intervention and to determine the effect size of the intervention on pain severity.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Inflammatory Breast Neoplasms; Inflammatory Breast Cancer Stage IV
• Intervention / Treatment: Behavioral: Self-Administered Hypnosis; Behavioral: Self-Administered White Noise Hypnosis

Detailed Description

Envision is a randomized, 2-arm, mixed-methods pilot study to evaluate the feasibility of translating a promising in-person hypnosis intervention for advanced cancer pain into a culturally appropriate, remotely delivered hypnosis intervention for pain in Black women with advanced cancer. The study is 6 weeks long and does not require any in-person visits. If a breast cancer survivor is determined eligible, they will be educated on the purpose, requirements, and procedures. If interested, participants will be emailed the consent form and will schedule a virtual consent/baseline visit. After consent is obtained, the participant will be randomly assigned to one of two types of hypnotic relaxation to be used alongside current pain treatment using 1:1 randomization and given a study number. The participant will complete online surveys at the virtual baseline visit. An MP3 player with hypnotic relaxation audio files will be sent to the participant's address and a virtual education visit will be scheduled. At this second virtual visit, participants will receive education about their study arm and a start date will be agreed upon for week 1. Beginning week 1 and continuing through week 6, participants will listen to their assigned hypnotic relaxation audio files daily and be asked to complete a weekly practice log. Participants will also continue to meet with study staff virtually for weekly check-ins. At these weekly meetings, progress and adverse events will be assessed and relevant online surveys will be completed.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • University of Tennessee Knoxville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older Black female
2. Diagnosed with Stage IV Breast Cancer with life expectancy of 6 months or more
3. Ability to read and write English
4. Ability to complete questionnaire(s) by themselves or with assistance.
5. Report cancer-related pain that they rate as ≥4 on a numeric pain rating scale of 0-10 with 0 being "no pain" and 10 being "the worst it can be" for the past month or more.
6. Ability to provide informed written consent.

Exclusion Criteria:

1. Diagnosis of major depressive disorder or acute anxiety disorder per the medical record or self-report in the past 2 years
2. Serious psychological illness, specifically psychoses, schizophrenia, or borderline personality disorder per the medical record or self-report
3. Currently enrolled in hospice
4. Currently using hypnosis for any reason
5. Non-English speaking
6. Unable to complete questionnaires or follow directions independently.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-Administered Hypnosis; Self-administered hypnosis will be practiced daily, at home for 6 weeks. Hypnosis sessions are expected to last ~20 minutes. Practices using the recordings will be documented on the Hypnosis Practice Log.	Behavioral: Self-Administered Hypnosis; Participants will choose from one of three 20-minute prerecorded hypnosis audio files. Practices using the recordings will be documented on the hypnosis practice log.
Active Comparator: Self Administered White Noise Hypnosis; Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the virtual consent/baseline visit and the virtual education visit.	Behavioral: Self-Administered White Noise Hypnosis; Participants will be listening to the same 20-minute white noise audio recording for 6 weeks and will be encouraged to practice daily. Practices using the recordings will be documented on the hypnosis practice log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen failure rate (a measure of feasibility)	The number of women screened ineligible	Recruitment to screening (up to 3 months)
Accrual rate (a measure of feasibility)	The number of participants who consented divided by the number eligible	Screening to consent (up to 30 days)
Retention rate / acceptability (a measure of feasibility)	The number of participants who complete the 6 weeks of the study divided by the number who consented.	Baseline through study completion, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant experience	Determine factors affecting participant experience through open-ended interview questions.	consent to week 6
Pain severity and Interference	Change in Brief Pain Inventory-Short Form scores. The Brief Pain Inventory-Short Form contains two subscales, pain severity and pain interference. Both scales include individual items that are scored on a scale of 0-10. The pain severity scale includes 4 items, with a possible range of 0-40. The pain interference scale includes 7 items, with a possible range 0-70. Higher scores indicate greater pain severity and greater pain interference.	consent to week 6

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: Baylor University
• Investigators: Principal Investigator: Noel M Arring, DNP, PhD, RN, University of Tennessee Knoxville

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): May 8, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; hypnosis; pain management; cancer pain; Black or African American
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Neoplasms; Breast Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Inflammatory Breast Neoplasms
• Other Study ID Numbers: UTK-IRB-23-07650-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data-sharing requests for deidentified data as appropriate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No