Cancerejames3NCT07742449
Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment
A study testing Empowered Relief in people with Cancer and Pain, run by University of Oklahoma at 1 site in United States.
Trial summary
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Pain, Pain Management
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identifies as American Indian
- Has history of a cancer diagnosis
- Is currently undergoing or has completed active cancer treatment
- Experiences body pain most or every day
- Pain duration at least 3 months
- English fluency
Who cannot join
- Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
- Life-threatening acute illness (e.g., infection, heart attack, injury)
- No access to a computer, a smartphone, or a tablet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stephenson Cancer Center - Tulsa Location
Tulsa, Oklahoma, 74104
Sophia You, 918-660-3925, dokyoung-you@ou.edu
About this study
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.
- Conditions
- Cancer, Pain, Pain Management, Chronic Pain, American Indian or Alaska Native
- Being tested
- Empowered Relief
- Keywords
- Cancer, Cancer Survivor, Pain, Chronic Pain, Native American, American Indian
- Medical subject headings
- Neoplasms, Pain, Agnosia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief | Experimental | Participants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. Participants will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention. Receives: Behavioral: Empowered Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of ER in American Indian populations
Indexed by:
- ≥70% attendance rate amongst all eligible participants
- An average treatment satisfaction rating of ≥ 8 on a 0-10 scale (with 0 being completely dissatisfied and 10 being completely satisfied)
- Successful recruitment and completion of 70 participants within one year
Measures will be factored together to make an assessment on total feasibility.
Measured: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
Identify areas for cultural tailoring and improvement of ER
We will use qualitative data from interviews to generate actionable recommendations to improve the cultural engagement, acceptability, and relevance of ER for American Indians with cancer.
Measured: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
Pain Intensity
Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."
Measured: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
Pain Interference
Pain interference will be gauged using a series of questions decerning the impact of the participants participants pain on daily activities. Participants will rate the interference on a scale from 1-5, with 1 being "Not at All" and 5 being "Very Much."
Measured: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Emotional Distress
Emotional distress will be measured using a series of questionnaires asking participants about the frequency of certain emotional reactions. Participants will report frequency on a scale from 1-5, with 1 being "Never" and 5 being "Always."
Measured: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Sleep Disturbance
Sleep Disturbance will be recorded using a series of questions rating the quality and frequency of sleep. Participants will report on quality and frequency on a scale from 1-5, with 1 being "Very Poor/Not at All" and 5 being "Very Good/Very Much."
Measured: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Perceived Quality of Life
Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent."
Measured: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startOct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophia You, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742449
- Sponsor's protocol ID
- 20065Ph1
- Acronym
- ejames3
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Empowered Relief for American Indians With Pain During and After Cancer Treatment
- ClinicalTrials.gov ID
- NCT07742449
- Acronym / sponsor ID
- ejames3 / 20065Ph1
- Conditions
- Cancer, Pain, Pain Management, Chronic Pain, American Indian or Alaska Native
- Keywords
- Cancer, Cancer Survivor, Pain, Chronic Pain, Native American, American Indian
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2026 (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.
This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief | Experimental | Behavioral: Empowered ReliefParticipants in this arm will complete a 2-hour Empowered Relief pain management course and get access to all the course materials. Participants will complete a series of follow-up surveys assessing the feasibility of the class for their pain intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identifies as American Indian
- Has history of a cancer diagnosis
- Is currently undergoing or has completed active cancer treatment
- Experiences body pain most or every day
- Pain duration at least 3 months
Key exclusion criteria (3 listed)
- Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the Zoom-based ER class)
- Life-threatening acute illness (e.g., infection, heart attack, injury)
- No access to a computer, a smartphone, or a tablet
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 |
|---|---|---|
| Empowered ReliefER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. | Behavioural | Empowered Relief |
Primary outcome
Feasibility of ER in American Indian populations
Time frame: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)
Indexed by: * ≥70% attendance rate amongst all eligible participants * An average treatment satisfaction rating of ≥ 8 on a 0-10 scale (with 0 being completely dissatisfied and 10 being completely satisfied) * Successful recruitment and completion of 70 participants within one year Measures will be factored together to make an assessment on total feasibility.
Identify areas for cultural tailoring and improvement of ER
Time frame: Assessed as part of the optional (n=30) Qualitative Post-class interview. (approx. 30 minutes)
We will use qualitative data from interviews to generate actionable recommendations to improve the cultural engagement, acceptability, and relevance of ER for American Indians with cancer.
Pain Intensity
Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class
Pain intensity will be reported on a scale from 1-10, with 1 being "No Pain" and 10 being "Worst Pain Imaginable."
Pain Interference
Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Pain interference will be gauged using a series of questions decerning the impact of the participants participants pain on daily activities. Participants will rate the interference on a scale from 1-5, with 1 being "Not at All" and 5 being "Very Much."
Emotional Distress
Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Emotional distress will be measured using a series of questionnaires asking participants about the frequency of certain emotional reactions. Participants will report frequency on a scale from 1-5, with 1 being "Never" and 5 being "Always."
Sleep Disturbance
Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Sleep Disturbance will be recorded using a series of questions rating the quality and frequency of sleep. Participants will report on quality and frequency on a scale from 1-5, with 1 being "Very Poor/Not at All" and 5 being "Very Good/Very Much."
Perceived Quality of Life
Time frame: Data collected at the 1-, 2-, and 3-month follow up survey following the ER class.
Perceived Quality of Life will be reported on a scale from 1-5, with 1 being "Poor" and 5 being "Excellent."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Sophia You principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief in people with Cancer and Pain, run by University of Oklahoma 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 3 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Keast (405-615-1474, jordan-keast@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of ER in American Indian populations (time frame: From participant accrual to the completion of their 3-mon follow up survey (approx. 4 months)). The study lists 7 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 18 Sep 2026.