Brain CancerLWBCNCT07628647
Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being
A study testing Group Self-Management Sessions and Educational Materials Only in people with Brain Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- Group Self-Management Sessions and Educational Materials Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2026to 31 Oct 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
- Currently living in the United States
- Aged 18 years or older
- Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
- Treating prescribing provider who follows regularly with participant
Who cannot join
- <1 month since initial diagnosis and/or <1 month since surgical resection
- Enrollment in hospice
- Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
- Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
- Not able to communicate in English at a conversational level
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Research Services Professional, LWBC@cuanschutz.edu
Bethany M Kwan, PhD, MSPH
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Molly McVoy, MD
About this study
Official title: Pilot Study of the Living Well With Brain Cancer Intervention
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:
- Is it feasible to conduct this program?
- Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
- Conditions
- Brain Cancer
- Being tested
- Group Self-Management Sessions, Educational Materials Only
- Keywords
- Brain cancer, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma, Brain tumor, Mental health, Glioma, Quality of life
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma, Psychological Well-Being, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Self-Management SessionsBehavioural
Also called Self-management intervention
Our targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel. A nurse educator and peer educator will facilitate the virtual sessions. The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer.
Educational Materials OnlyOther
Also called Content only
Self-management content specifically designed for people with brain cancer will be uploaded into a learning management system. The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm. There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content.
| Study group | Role | What they receive |
|---|---|---|
| Group Self-Management Arm | Experimental | Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content. Receives: Behavioral: Group Self-Management Sessions |
| Education Only Arm | Active comparator | Participants in this arm will be invited to use an online learning management system to access the educational materials. There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials. Receives: Other: Educational Materials Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
Measured: Baseline, immediately post-intervention, and 3 months post-intervention
Secondary outcomes (10)
Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Change from Baseline to immediately after intervention in score of NIH Toolbox Item Bank v3.0 - Percevied Stress (Ages 18+) - Fixed Form
Measured: Baseline and immediately post-intervention
Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Change from baseline to immediately post-intervention in score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Measured: Baseline and immediately post-intervention
Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
Measured: Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
Measured: Baseline and immediately post-intervention
Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
Measured: Baseline
Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys
Measured: Baseline
Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
Change in score from baseline to immediately post-intervention of the Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activites - Short Form survey
Measured: Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey
Measured: Baseline and immediately post-intervention
Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
Change in score from baseline to immediately post-intervention from the PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a survey
Measured: Baseline and immediately post-intervention
Survival
Self/contact-reported survival
Measured: Immediate post-intervention, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start10 Jun 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, U.S. Army Medical Research and Development Command, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Bethany M Kwan, PhD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628647
- Sponsor's protocol ID
- 25-2124
- Other IDs
- HT9425-24-1-0883
- Acronym
- LWBC
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.
Publications
Krippendorff K. Content analysis: An introduction to its methodology. Sage publications; 2013.
Stemler S. An overview of content analysis. Practical Assessment. Research & Evaluation. 2001;7(17): 137-146.
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.
PubMed 28239781Gabel N, Altshuler DB, Brezzell A, Briceno EM, Boileau NR, Miklja Z, Kluin K, Ferguson T, McMurray K, Wang L, Smith SR, Carlozzi NE, Hervey-Jumper SL. Health Related Quality of Life in Adult Low and High-Grade Glioma Patients Using the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) and Neuro-QOL Assessments. Front Neurol. 2019 Mar 15;10:212. doi: 10.3389/fneur.2019.00212. eCollection 2019.
PubMed 30930834Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27.
PubMed 21874314Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
PubMed 28472964Blixen C, Perzynski A, Kanuch S, Dawson N, Kaiser D, Lawless ME, Seeholzer E, Sajatovic M. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting. Prim Health Care Res Dev. 2015 Apr;16(2):127-37. doi: 10.1017/S1463423614000176. Epub 2014 Apr 7.
PubMed 24703014Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
PubMed 1100130Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.
PubMed 4597226McVoy M, Delbello M, Levin J, Modi AC, Forthun LF, Briggs F, Appling D, Broadnax M, Conroy C, Cooley R, Eapen G, Sajatovic M. A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report. Contemp Clin Trials. 2022 Apr;115:106729. doi: 10.1016/j.cct.2022.106729. Epub 2022 Mar 9.
PubMed 35278693Barr VJ, Robinson S, Marin-Link B, Underhill L, Dotts A, Ravensdale D, Salivaras S. The expanded Chronic Care Model: an integration of concepts and strategies from population health promotion and the Chronic Care Model. Hosp Q. 2003;7(1):73-82. doi: 10.12927/hcq.2003.16763.
PubMed 14674182Reynolds R, Dennis S, Hasan I, Slewa J, Chen W, Tian D, Bobba S, Zwar N. A systematic review of chronic disease management interventions in primary care. BMC Fam Pract. 2018 Jan 9;19(1):11. doi: 10.1186/s12875-017-0692-3.
PubMed 29316889Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available.
PubMed 8374477Cramer JA, Perrine K, Devinsky O, Meador K. A brief questionnaire to screen for quality of life in epilepsy: the QOLIE-10. Epilepsia. 1996 Jun;37(6):577-82. doi: 10.1111/j.1528-1157.1996.tb00612.x.
PubMed 8641236Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.
PubMed 444788
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Living Well With Brain Cancer Intervention
- ClinicalTrials.gov ID
- NCT07628647
- Acronym / sponsor ID
- LWBC / 25-2124
- Conditions
- Brain Cancer
- Keywords
- Brain cancer, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma, Brain tumor, Mental health, Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, U.S. Army Medical Research and Development Command, Case Western Reserve University
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Jun 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.
The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:
- Is it feasible to conduct this program?
- Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Self-Management Arm | Experimental | Behavioral: Group Self-Management SessionsParticipants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content. |
| Education Only Arm | Active comparator | Other: Educational Materials OnlyParticipants in this arm will be invited to use an online learning management system to access the educational materials. There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently living in the United States
- Aged 18 years or older
- Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
- Treating prescribing provider who follows regularly with participant
Key exclusion criteria (5 listed)
- <1 month since initial diagnosis and/or <1 month since surgical resection
- Enrollment in hospice
- Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
- Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
- Not able to communicate in English at a conversational level
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 |
|---|---|---|
| Group Self-Management SessionsAlso: Self-management interventionOur targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel. A nurse educator and peer educator will facilitate the virtual sessions. The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer. | Behavioural | Group Self-Management Arm |
| Educational Materials OnlyAlso: Content onlySelf-management content specifically designed for people with brain cancer will be uploaded into a learning management system. The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm. There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content. | Other | Education Only Arm |
Primary outcome
Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Time frame: Baseline, immediately post-intervention, and 3 months post-intervention
Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
10 secondary outcomes
Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Time frame: Baseline and immediately post-intervention
Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Time frame: Baseline and immediately post-intervention
Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Time frame: Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Time frame: Baseline and immediately post-intervention
Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Time frame: Baseline
Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Time frame: Baseline
Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
Time frame: Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Time frame: Baseline and immediately post-intervention
Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
Time frame: Baseline and immediately post-intervention
Survival
Time frame: Immediate post-intervention, 3 months post-intervention
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 3 Nov 2026.
- BackgroundKrippendorff K. Content analysis: An introduction to its methodology. Sage publications; 2013.
- BackgroundStemler S. An overview of content analysis. Practical Assessment. Research & Evaluation. 2001;7(17): 137-146.
- Background: PubMed 28239781Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.
- Background: PubMed 30930834Gabel N, Altshuler DB, Brezzell A, Briceno EM, Boileau NR, Miklja Z, Kluin K, Ferguson T, McMurray K, Wang L, Smith SR, Carlozzi NE, Hervey-Jumper SL. Health Related Quality of Life in Adult Low and High-Grade Glioma Patients Using the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) and Neuro-QOL Assessments. Front Neurol. 2019 Mar 15;10:212. doi: 10.3389/fneur.2019.00212. eCollection 2019.
- Background: PubMed 21874314Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27.
- Background: PubMed 28472964Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
- Background: PubMed 24703014Blixen C, Perzynski A, Kanuch S, Dawson N, Kaiser D, Lawless ME, Seeholzer E, Sajatovic M. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting. Prim Health Care Res Dev. 2015 Apr;16(2):127-37. doi: 10.1017/S1463423614000176. Epub 2014 Apr 7.
- Background: PubMed 1100130Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
- Background: PubMed 4597226Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.
- Background: PubMed 35278693McVoy M, Delbello M, Levin J, Modi AC, Forthun LF, Briggs F, Appling D, Broadnax M, Conroy C, Cooley R, Eapen G, Sajatovic M. A customized adherence enhancement program for adolescents and young adults with suboptimal adherence and bipolar disorder: Trial design and methodological report. Contemp Clin Trials. 2022 Apr;115:106729. doi: 10.1016/j.cct.2022.106729. Epub 2022 Mar 9.
- Background: PubMed 14674182Barr VJ, Robinson S, Marin-Link B, Underhill L, Dotts A, Ravensdale D, Salivaras S. The expanded Chronic Care Model: an integration of concepts and strategies from population health promotion and the Chronic Care Model. Hosp Q. 2003;7(1):73-82. doi: 10.12927/hcq.2003.16763.
- Background: PubMed 29316889Reynolds R, Dennis S, Hasan I, Slewa J, Chen W, Tian D, Bobba S, Zwar N. A systematic review of chronic disease management interventions in primary care. BMC Fam Pract. 2018 Jan 9;19(1):11. doi: 10.1186/s12875-017-0692-3.
- Individual participant dataSharing planned: No. The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.
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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.
Bethany M Kwan, PhD, MSPH principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Self-Management Sessions and Educational Materials Only in people with Brain Cancer, run by University of Colorado, Denver at 2 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Research Services Professional (303-724-1723, lwbc@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36) (time frame: Baseline, immediately post-intervention, and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07628647, which also lists 55 linked publications.
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 3 Nov 2026.