Breast CancerNCT06057636
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Breast Cancer and Inflammatory Breast Cancer Stage IV, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Inflammatory Breast Cancer Stage IV, Inflammatory Breast Neoplasms
- What is being tested?
- Self-Administered Hypnosis and Self-Administered White Noise Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Knoxville
Knoxville, Tennessee, 37996
About this study
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.
Read the 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
- Being tested
- Self-Administered Hypnosis, Self-Administered White Noise Hypnosis
- Keywords
- breast cancer, cancer pain, pain management, hypnosis, Black or African American
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasm Metastasis, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered HypnosisBehavioural
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 HypnosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Administered White Noise Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen failure rate (a measure of feasibility)
The number of women screened ineligible
Measured: Recruitment to screening (up to 3 months)
Accrual rate (a measure of feasibility)
The number of participants who consented divided by the number eligible
Measured: 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.
Measured: Baseline through study completion, 6 weeks
Secondary outcomes (2)
Participant experience
Determine factors affecting participant experience through open-ended interview questions.
Measured: consent to week 6
Pain severity and Interference
Change in Brief Pain Inventory-Short Form scores. The Brief Pain Inventory-Short Form contains two subscales, pain severity and pain interference. Both scales include individual items that are scored on a scale of 0-10. The pain severity scale includes 4 items, with a possible range of 0-40. The pain interference scale includes 7 items, with a possible range 0-70. Higher scores indicate greater pain severity and greater pain interference.
Measured: consent to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start8 Sep 2023
- Primary completion8 May 2024
- Study completion8 May 2024
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University
- Responsible party
- Principal investigator, Noel Arring, The University of Tennessee, Knoxville
- Investigators
- Noel M Arring, DNP, PhD, RN, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057636
- Sponsor's protocol ID
- UTK-IRB-23-07650-XP
- Status last verified
- May 2024
- First submitted
- 19 Sep 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data-sharing requests for deidentified data as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06057636
- Acronym / sponsor ID
- UTK-IRB-23-07650-XP
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Baylor University
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Self-Administered Hypnosis | Experimental | Behavioral: Self-Administered HypnosisSelf-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. |
| Self Administered White Noise Hypnosis | Active comparator | Behavioral: Self-Administered White Noise HypnosisSelf-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Administered HypnosisParticipants will choose from one of three 20-minute prerecorded hypnosis audio files. Practices using the recordings will be documented on the hypnosis practice log. | Behavioural | Self-Administered Hypnosis |
| Self-Administered White Noise HypnosisParticipants 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. | Behavioural | Self Administered White Noise Hypnosis |
Primary outcome
Screen failure rate (a measure of feasibility)
Time frame: Recruitment to screening (up to 3 months)
The number of women screened ineligible
Accrual rate (a measure of feasibility)
Time frame: Screening to consent (up to 30 days)
The number of participants who consented divided by the number eligible
Retention rate / acceptability (a measure of feasibility)
Time frame: Baseline through study completion, 6 weeks
The number of participants who complete the 6 weeks of the study divided by the number who consented.
2 secondary outcomes
Participant experience
Time frame: consent to week 6
Pain severity and Interference
Time frame: consent to week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No. This is a small pilot study and as such, data will be thoroughly interrogated. However, if an investigator feels there are unanswered questions or wishes to add to a larger dataset, we would entertain all data-sharing requests for deidentified data as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel M Arring, DNP, PhD, RN principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Breast Cancer and Inflammatory Breast Cancer Stage IV, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen failure rate (a measure of feasibility) (time frame: Recruitment to screening (up to 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.