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Behavioral Intervention

Hypnosis for Advanced Breast Cancer

N/A

Recruiting

Led By Noel M Arring, DNP, PhD, RN

Research Sponsored by The University of Tennessee, Knoxville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older Black female

Diagnosed with Stage IV Breast Cancer with life expectancy of 6 months or more

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recruitment to screening (up to 3 months)

Awards & highlights

Study Summary

This trial will compare two hypnotic interventions for Black women with advanced cancer pain to determine if a larger study is possible.

Who is the study for?

This trial is for adult Black women over 18 with Stage IV Breast Cancer who have a life expectancy of at least 6 months. They must be experiencing significant cancer-related pain, able to read and write English, and complete questionnaires. Women in hospice or currently using hypnosis, those with certain psychological conditions, or unable to follow directions independently cannot participate.Check my eligibility

What is being tested?

The study compares two types of hypnotic interventions aimed at managing advanced cancer pain in preparation for a larger phase III trial. It's a pilot randomized controlled trial where participants will either use self-administered hypnosis or white noise hypnosis to assess feasibility and measure the impact on pain severity.See study design

What are the potential side effects?

Since the interventions involve non-invasive techniques like hypnosis and white noise listening sessions, there are no direct medical side effects expected from participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult Black woman.

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I have Stage IV Breast Cancer and am expected to live 6 months or more.

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I have experienced cancer-related pain of 4 or more on a scale of 0-10 for the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recruitment to screening (up to 3 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recruitment to screening (up to 3 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and recruitment to screening (up to 3 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accrual rate (a measure of feasibility)

Retention rate / acceptability (a measure of feasibility)

Screen failure rate (a measure of feasibility)

Secondary outcome measures

Pain severity and Interference

Participant experience

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Administered HypnosisExperimental Treatment1 Intervention

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 II: Self Administered White Noise HypnosisActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Self-Administered Hypnosis

2018

N/A

~290

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor UniversityOTHER

56 Previous Clinical Trials

65,164 Total Patients Enrolled

2 Trials studying Breast Cancer

258 Patients Enrolled for Breast Cancer

The University of Tennessee, KnoxvilleLead Sponsor

83 Previous Clinical Trials

18,529 Total Patients Enrolled

2 Trials studying Breast Cancer

67 Patients Enrolled for Breast Cancer

Noel M Arring, DNP, PhD, RNPrincipal InvestigatorUniversity of Tennessee Knoxville

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Breast Cancer

60 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial allow for the participation of individuals under fifty years old?

"Patients of 18 years or more and below 99 years of age may apply to partake in this clinical trial."

Answered by AI

How many people are currently participating in this trial?

"Affirmative. Clinicaltrials.gov displays evidence that this medical study, which originated on September 8th 2023, is actively recruiting patients for a total of 30 individuals from 1 site."

Answered by AI

Are there any open enrollment opportunities to participate in this experiment?

"Affirmative. The information available on clinicaltrials.gov confirms that the trial is actively searching for eligible participants, beginning with its initial posting date of September 8th 2023 and most recent update dated to September 26th 2023. 30 patients are needed from one medical centre."

Answered by AI