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

NCT ID: NCT06057636

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2024-05-08

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-Administered Hypnosis

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Self-Administered White Noise Hypnosis

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor University

OTHER

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: lead

Responsible Party

Noel Arring

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noel M Arring, DNP, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Knoxville

Locations

University of Tennessee Knoxville

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

UTK-IRB-23-07650-XP

Identifier Type: -

Identifier Source: org_study_id