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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057636
• Other study ID #: UTK-IRB-23-07650-XP
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: The University of Tennessee, Knoxville
• Contact: Noel M Arring, DNP, PhD, RN
• Phone: (865) 974-1988
• Email: CASSI[@]utk.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Inflammatory Breast Cancer Stage IV
• Neoplasm Metastasis
• Neoplasms
• Triple Negative Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Tennessee Knoxville	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screen failure rate (a measure of feasibility)	The number of women screened ineligible	Recruitment to screening (up to 3 months)
Primary	Accrual rate (a measure of feasibility)	The number of participants who consented divided by the number eligible	Screening to consent (up to 30 days)
Primary	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	Participant experience	Determine factors affecting participant experience through open-ended interview questions.	consent to week 6
Secondary	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