Clinical trial · Interventional
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit participants
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Inflammatory Breast Cancer Stage IV | Breast Inflammatory Carcinoma | CURATED_BROADER | 0.78 |
| Inflammatory Breast Neoplasms | Breast Inflammatory Carcinoma | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-Administered Hypnosis | Behavioral | — | UNRESOLVED |
| Self-Administered White Noise Hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-Administered Hypnosis
- description
- 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.
- interventionNames
- Behavioral: Self-Administered Hypnosis
- type
- ACTIVE_COMPARATOR
- label
- Self Administered White Noise Hypnosis
- description
- 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.
- interventionNames
- Behavioral: Self-Administered White Noise Hypnosis
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available