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

NCT06057636 | Withdrawn

• 1 other identifier: UTK-IRB-23-07650-XP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

breast cancer; cancer pain; pain management; hypnosis; Black or African American

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Participant experience

  consent to week 6

• Pain severity and Interference

  consent to week 6

Study Arms (2)

Self-Administered Hypnosis

EXPERIMENTAL

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

Self Administered White Noise Hypnosis

ACTIVE COMPARATOR

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

Interventions

Self-Administered Hypnosis 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 Hypnosis

Self-Administered White Noise Hypnosis 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.

Self Administered White Noise Hypnosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older Black female
• Diagnosed with Stage IV Breast Cancer with life expectancy of 6 months or more
• Ability to read and write English
• Ability to complete questionnaire(s) by themselves or with assistance.
• 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.
• Ability to provide informed written consent.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Baylor University: collaborator

Study Sites (1)

University of Tennessee Knoxville

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasm Metastasis; Cancer Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Noel M Arring, DNP, PhD, RN

  University of Tennessee Knoxville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-masking, participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a two-arm, randomized clinical trial.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 28, 2023
• Study Start: September 8, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)