Clinical trial NCT06057636: Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
Official title: Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Baylor University
First posted: 2023-09-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Screen failure rate (a measure of feasibility)
timeFrame: Recruitment to screening (up to 3 months)
measure: Accrual rate (a measure of feasibility)
timeFrame: Screening to consent (up to 30 days)
measure: Retention rate / acceptability (a measure of feasibility)
timeFrame: Baseline through study completion, 6 weeks
Secondary outcomes:
measure: Participant experience
timeFrame: consent to week 6
measure: Pain severity and Interference
timeFrame: consent to week 6
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Knoxville
state: Tennessee
Study officials:
affiliation: University of Tennessee Knoxville
name: Noel M Arring, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: