Prostate CancerNCT03852017
Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
A study testing Audio Program in people with Prostate Cancer, run by Northwestern University.
Trial summary
In this study, the researchers will examine the implementation feasibility, acceptability, and initial effects of a brief eHealth mindfulness intervention, compared to brief relaxing music, to reduce self-reported symptoms of fatigue, anxiety, depression and sleep disturbance in a sample of localized prostate cancer… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Audio Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2015to 8 Jan 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with clinically localized prostate cancer
- Will receive at least 7 weeks of daily radiation therapy
- At least 18 years of age
- Able to speak and understand English
- Cognitively intact and free of serious psychiatric illness (as determined by referring physician)
Who cannot join
- Regular user of mindfulness meditation, which is defined as ≥ 3 times a week for the past 4 weeks
About this study
Official title: IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
In this study, the researchers will examine the implementation feasibility, acceptability, and initial effects of a brief eHealth mindfulness intervention, compared to brief relaxing music, to reduce self-reported symptoms of fatigue, anxiety, depression and sleep disturbance in a sample of localized prostate cancer patients during the receipt of radiation therapy.
Read the detailed description
Eligible patients will be recruited from Northwestern Medicine's Department of Radiation Oncology and Northwestern Memorial Hospital. Participants will complete an online questionnaire prior to beginning the intervention. Following implementation pre-testing, the intervention will begin on Week 2 of radiation therapy and last 4 weeks. Upon arrival for their treatment visit, they will receive the audio program from the clinic staff. They will start the program prior to their treatment. Participants will be asked to listen to the audio-program during their radiation treatment visits, using a Bluetooth-enabled MP3 player with speaker instead of headphones or earbuds because they are not permitted during radiation therapy. The patient's ears need to be free to hear a possible communication from the radiation therapists if need be. Audio program recordings will run 3-12 minutes. Participants will turn off the program after their audio session has ended and return the audio program to the clinic staff after their treatment visit. Participants will complete an online question immediately after completing the intervention, and again 1 and 3 months later.
- Conditions
- Prostate Cancer
- Being tested
- Audio Program
- Keywords
- prostate cancer, mindfulness, music
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Audio Program | Experimental | Mindfulness Audio Program is a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life Receives: Behavioral: Audio Program |
| Music Audio Program | Active comparator | Music Audio Program is a daily audio session of peaceful and relaxing music Receives: Behavioral: Audio Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation feasibility measured by enrollment rate
This indicator of implementation feasibility for the program being delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached).
Measured: Baseline
Implementation feasibility measured by retention rate
This indicator of implementation feasibility for the program delivered is defined by the retention rate being >/=70% (e.g., total number of individuals who remained in the trial until the end of requested participation/total number of individuals enrolled).
Measured: Throughout study completion, a total of four months.
Implementation feasibility measured by intervention adherence
This indicator of implementation feasibility for the program delivered is defined by an adherence rate of >/=70% of all possible listening opportunities during the study intervention period.
Measured: Throughout the study intervention period, a total of 4 weeks.
Program acceptability measured by a post-program survey at 4-weeks
Program acceptability will be assessed using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as ≥70% of survey responses in affirmation of this.
Measured: Week 4
Secondary outcomes (7)
Significant change in fatigue using the PROMIS Fatigue questionnaire
Participants were administered the PROMIS Fatigue questionnaire. Significant change was indicated by a p<.05 on fatigue scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Significant change in anxiety using the PROMIS Anxiety questionnaire
Participants were administered the PROMIS Anxiety questionnaire. Significant change was indicated by a p<.05 on anxiety scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Change in depression using the PROMIS Depression questionnaire
Participants were administered the PROMIS Depression questionnaire. Significant change was indicated by a p<.05 on depression scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Change in sleep using the PROMIS Sleep Disturbance questionnaire
Participants were administered the PROMIS Sleep Disturbance questionnaire. Significant change was indicated by a p<.05 on sleep disturbance scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
Participants were administered the Intolerance for Uncertainty questionnaire. Significant change was indicated by a p<.05 on uncertainty intolerance scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
Participants were administered the MAX-PC Fear of Recurrence questionnaire. Significant change was indicated by a p<.05 on fear of recurrence scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Change in mindfulness using the Mindful Attention Awareness Scale
Participants were administered the Mindful Attention Awareness Scale. Significant change was indicated by a p<.05 on mindfulness scores between baseline and follow up time points between study arms.
Measured: baseline; Week 4; Month 1; Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start11 Nov 2015
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Model description
- Following implementation pre-testing, we will use a pilot randomized-controlled design to compare 2 groups: Group A: Mindfulness (n=25), a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life; and Group B: Relaxing Music (n=25) - a daily audio session of peaceful and relaxing music. Participants will be assessed at baseline just prior to randomization to the two study arms (T1), followed by assessments at the end of the intervention period (T2), and 1 month (T3) and 3 months (T4) after the 4-week intervention period.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Victorson, Northwestern University
- Investigators
- David E Victorson, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852017
- Sponsor's protocol ID
- STU00200537
- Status last verified
- May 2023
- First submitted
- 12 Dec 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berkey FJ. Managing the adverse effects of radiation therapy. Am Fam Physician. 2010 Aug 15;82(4):381-8, 394.
PubMed 20704169Jereczek-Fossa BA, Santoro L, Alterio D, Franchi B, Fiore MR, Fossati P, Kowalczyk A, Canino P, Ansarin M, Orecchia R. Fatigue during head-and-neck radiotherapy: prospective study on 117 consecutive patients. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):403-15. doi: 10.1016/j.ijrobp.2007.01.024. Epub 2007 Mar 29.
PubMed 17398020Jereczek-Fossa BA, Marsiglia HR, Orecchia R. Radiotherapy-related fatigue. Crit Rev Oncol Hematol. 2002 Mar;41(3):317-25. doi: 10.1016/s1040-8428(01)00143-3.
PubMed 11880207Groenvold M, Petersen MA, Idler E, Bjorner JB, Fayers PM, Mouridsen HT. Psychological distress and fatigue predicted recurrence and survival in primary breast cancer patients. Breast Cancer Res Treat. 2007 Oct;105(2):209-19. doi: 10.1007/s10549-006-9447-x. Epub 2007 Jan 3.
PubMed 17203386Kawase E, Karasawa K, Shimotsu S, Izawa H, Hirowatari H, Saito AI, Ito K, Horikawa N. Estimation of anxiety and depression in patients with early stage breast cancer before and after radiation therapy. Breast Cancer. 2012 Apr;19(2):147-52. doi: 10.1007/s12282-010-0220-y. Epub 2010 Sep 3.
PubMed 20814770Society AC. American Cancer Society Cancer Facts & Figures. Atlanta: American Cancer Society; 2014
Garrett K, Dhruva A, Koetters T, West C, Paul SM, Dunn LB, Aouizerat BE, Cooper BA, Dodd M, Lee K, Wara W, Swift P, Miaskowski C. Differences in sleep disturbance and fatigue between patients with breast and prostate cancer at the initiation of radiation therapy. J Pain Symptom Manage. 2011 Aug;42(2):239-50. doi: 10.1016/j.jpainsymman.2010.11.010. Epub 2011 Mar 31.
PubMed 21454042Knapp K, Cooper B, Koetters T, Cataldo J, Dhruva A, Paul SM, West C, Aouizerat BE, Miaskowski C. Trajectories and predictors of symptom occurrence, severity, and distress in prostate cancer patients undergoing radiation therapy. J Pain Symptom Manage. 2012 Oct;44(4):486-507. doi: 10.1016/j.jpainsymman.2011.10.020. Epub 2012 Jul 7.
PubMed 22771128Miaskowski C, Paul SM, Cooper BA, Lee K, Dodd M, West C, Aouizerat BE, Dunn L, Swift PS, Wara W. Predictors of the trajectories of self-reported sleep disturbance in men with prostate cancer during and following radiation therapy. Sleep. 2011 Feb 1;34(2):171-9. doi: 10.1093/sleep/34.2.171.
PubMed 21286498Mohamed NE, Bovbjerg DH, Montgomery GH, Hall SJ, Diefenbach MA. Pretreatment depressive symptoms and treatment modality predict post-treatment disease-specific quality of life among patients with localized prostate cancer. Urol Oncol. 2012 Nov-Dec;30(6):804-12. doi: 10.1016/j.urolonc.2011.02.002. Epub 2011 Jul 27.
PubMed 21795078Monga U, Garber SL, Thornby J, Vallbona C, Kerrigan AJ, Monga TN, Zimmermann KP. Exercise prevents fatigue and improves quality of life in prostate cancer patients undergoing radiotherapy. Arch Phys Med Rehabil. 2007 Nov;88(11):1416-22. doi: 10.1016/j.apmr.2007.08.110.
PubMed 17964881Vadiraja HS, Rao MR, Nagarathna R, Nagendra HR, Rekha M, Vanitha N, Gopinath KS, Srinath BS, Vishweshwara MS, Madhavi YS, Ajaikumar BS, Bilimagga SR, Rao N. Effects of yoga program on quality of life and affect in early breast cancer patients undergoing adjuvant radiotherapy: a randomized controlled trial. Complement Ther Med. 2009 Oct-Dec;17(5-6):274-80. doi: 10.1016/j.ctim.2009.06.004. Epub 2009 Oct 28.
PubMed 19942107Portenoy RK. Cancer-related fatigue: An immense problem. Oncologist. 2000;5(5):350-2. doi: 10.1634/theoncologist.5-5-350. No abstract available.
PubMed 11040269Portenoy RK, Itri LM. Cancer-related fatigue: guidelines for evaluation and management. Oncologist. 1999;4(1):1-10.
PubMed 10337366Kim YH, Kim HJ, Ahn SD, Seo YJ, Kim SH. Effects of meditation on anxiety, depression, fatigue, and quality of life of women undergoing radiation therapy for breast cancer. Complement Ther Med. 2013 Aug;21(4):379-87. doi: 10.1016/j.ctim.2013.06.005. Epub 2013 Jul 6.
PubMed 23876569
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMERSE PC: Investigating Mindfulness and Music to Ease Radiation Side Effects in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03852017
- Acronym / sponsor ID
- STU00200537
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, mindfulness, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 22 Feb 2019 (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.
In this study, the researchers will examine the implementation feasibility, acceptability, and initial effects of a brief eHealth mindfulness intervention, compared to brief relaxing music, to reduce self-reported symptoms of fatigue, anxiety, depression and sleep disturbance in a sample of localized prostate cancer patients during the receipt of radiation therapy.
Detailed description
Eligible patients will be recruited from Northwestern Medicine's Department of Radiation Oncology and Northwestern Memorial Hospital. Participants will complete an online questionnaire prior to beginning the intervention. Following implementation pre-testing, the intervention will begin on Week 2 of radiation therapy and last 4 weeks. Upon arrival for their treatment visit, they will receive the audio program from the clinic staff. They will start the program prior to their treatment. Participants will be asked to listen to the audio-program during their radiation treatment visits, using a Bluetooth-enabled MP3 player with speaker instead of headphones or earbuds because they are not permitted during radiation therapy. The patient's ears need to be free to hear a possible communication from the radiation therapists if need be. Audio program recordings will run 3-12 minutes. Participants will turn off the program after their audio session has ended and return the audio program to the clinic staff after their treatment visit. Participants will complete an online question immediately after completing the intervention, and again 1 and 3 months later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following implementation pre-testing, we will use a pilot randomized-controlled design to compare 2 groups: Group A: Mindfulness (n=25), a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life; and Group B: Relaxing Music (n=25) - a daily audio session of peaceful and relaxing music. Participants will be assessed at baseline just prior to randomization to the two study arms (T1), followed by assessments at the end of the intervention period (T2), and 1 month (T3) and 3 months (T4) after the 4-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Audio Program | Experimental | Behavioral: Audio ProgramMindfulness Audio Program is a daily audio-session, which teaches emotional self-regulation skills through the adoption of mindful awareness practices into one's life |
| Music Audio Program | Active comparator | Behavioral: Audio ProgramMusic Audio Program is a daily audio session of peaceful and relaxing music |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with clinically localized prostate cancer
- Will receive at least 7 weeks of daily radiation therapy
- At least 18 years of age
- Able to speak and understand English
- Cognitively intact and free of serious psychiatric illness (as determined by referring physician)
Key exclusion criteria (1 listed)
- Regular user of mindfulness meditation, which is defined as ≥ 3 times a week for the past 4 weeks
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 |
|---|---|---|
| Audio Program | Behavioural | Mindfulness Audio Program, Music Audio Program |
Primary outcome
Implementation feasibility measured by enrollment rate
Time frame: Baseline
This indicator of implementation feasibility for the program being delivered is defined by the overall enrollment rate being >/= 70% (e.g., total number of individuals enrolled/total number approached).
Implementation feasibility measured by retention rate
Time frame: Throughout study completion, a total of four months.
This indicator of implementation feasibility for the program delivered is defined by the retention rate being >/=70% (e.g., total number of individuals who remained in the trial until the end of requested participation/total number of individuals enrolled).
Implementation feasibility measured by intervention adherence
Time frame: Throughout the study intervention period, a total of 4 weeks.
This indicator of implementation feasibility for the program delivered is defined by an adherence rate of >/=70% of all possible listening opportunities during the study intervention period.
Program acceptability measured by a post-program survey at 4-weeks
Time frame: Week 4
Program acceptability will be assessed using a brief, Likert-type survey assessing participant enjoyment, satisfaction, perceived benefit, and ease of use. Acceptability is defined as ≥70% of survey responses in affirmation of this.
7 secondary outcomes
Significant change in fatigue using the PROMIS Fatigue questionnaire
Time frame: baseline; Week 4; Month 1; Month 3
Significant change in anxiety using the PROMIS Anxiety questionnaire
Time frame: baseline; Week 4; Month 1; Month 3
Change in depression using the PROMIS Depression questionnaire
Time frame: baseline; Week 4; Month 1; Month 3
Change in sleep using the PROMIS Sleep Disturbance questionnaire
Time frame: baseline; Week 4; Month 1; Month 3
Change in uncertainty intolerance using the Intolerance for Uncertainty Scale
Time frame: baseline; Week 4; Month 1; Month 3
Change in fear of recurrence using the MAX-PC Fear of Recurrence sub-scale
Time frame: baseline; Week 4; Month 1; Month 3
Change in mindfulness using the Mindful Attention Awareness Scale
Time frame: baseline; Week 4; Month 1; Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 20704169Berkey FJ. Managing the adverse effects of radiation therapy. Am Fam Physician. 2010 Aug 15;82(4):381-8, 394.
- Background: PubMed 17398020Jereczek-Fossa BA, Santoro L, Alterio D, Franchi B, Fiore MR, Fossati P, Kowalczyk A, Canino P, Ansarin M, Orecchia R. Fatigue during head-and-neck radiotherapy: prospective study on 117 consecutive patients. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):403-15. doi: 10.1016/j.ijrobp.2007.01.024. Epub 2007 Mar 29.
- Background: PubMed 11880207Jereczek-Fossa BA, Marsiglia HR, Orecchia R. Radiotherapy-related fatigue. Crit Rev Oncol Hematol. 2002 Mar;41(3):317-25. doi: 10.1016/s1040-8428(01)00143-3.
- Background: PubMed 17203386Groenvold M, Petersen MA, Idler E, Bjorner JB, Fayers PM, Mouridsen HT. Psychological distress and fatigue predicted recurrence and survival in primary breast cancer patients. Breast Cancer Res Treat. 2007 Oct;105(2):209-19. doi: 10.1007/s10549-006-9447-x. Epub 2007 Jan 3.
- Background: PubMed 20814770Kawase E, Karasawa K, Shimotsu S, Izawa H, Hirowatari H, Saito AI, Ito K, Horikawa N. Estimation of anxiety and depression in patients with early stage breast cancer before and after radiation therapy. Breast Cancer. 2012 Apr;19(2):147-52. doi: 10.1007/s12282-010-0220-y. Epub 2010 Sep 3.
- BackgroundSociety AC. American Cancer Society Cancer Facts & Figures. Atlanta: American Cancer Society; 2014
- Background: PubMed 21454042Garrett K, Dhruva A, Koetters T, West C, Paul SM, Dunn LB, Aouizerat BE, Cooper BA, Dodd M, Lee K, Wara W, Swift P, Miaskowski C. Differences in sleep disturbance and fatigue between patients with breast and prostate cancer at the initiation of radiation therapy. J Pain Symptom Manage. 2011 Aug;42(2):239-50. doi: 10.1016/j.jpainsymman.2010.11.010. Epub 2011 Mar 31.
- Background: PubMed 22771128Knapp K, Cooper B, Koetters T, Cataldo J, Dhruva A, Paul SM, West C, Aouizerat BE, Miaskowski C. Trajectories and predictors of symptom occurrence, severity, and distress in prostate cancer patients undergoing radiation therapy. J Pain Symptom Manage. 2012 Oct;44(4):486-507. doi: 10.1016/j.jpainsymman.2011.10.020. Epub 2012 Jul 7.
- Background: PubMed 21286498Miaskowski C, Paul SM, Cooper BA, Lee K, Dodd M, West C, Aouizerat BE, Dunn L, Swift PS, Wara W. Predictors of the trajectories of self-reported sleep disturbance in men with prostate cancer during and following radiation therapy. Sleep. 2011 Feb 1;34(2):171-9. doi: 10.1093/sleep/34.2.171.
- Background: PubMed 21795078Mohamed NE, Bovbjerg DH, Montgomery GH, Hall SJ, Diefenbach MA. Pretreatment depressive symptoms and treatment modality predict post-treatment disease-specific quality of life among patients with localized prostate cancer. Urol Oncol. 2012 Nov-Dec;30(6):804-12. doi: 10.1016/j.urolonc.2011.02.002. Epub 2011 Jul 27.
- Background: PubMed 17964881Monga U, Garber SL, Thornby J, Vallbona C, Kerrigan AJ, Monga TN, Zimmermann KP. Exercise prevents fatigue and improves quality of life in prostate cancer patients undergoing radiotherapy. Arch Phys Med Rehabil. 2007 Nov;88(11):1416-22. doi: 10.1016/j.apmr.2007.08.110.
- Background: PubMed 19942107Vadiraja HS, Rao MR, Nagarathna R, Nagendra HR, Rekha M, Vanitha N, Gopinath KS, Srinath BS, Vishweshwara MS, Madhavi YS, Ajaikumar BS, Bilimagga SR, Rao N. Effects of yoga program on quality of life and affect in early breast cancer patients undergoing adjuvant radiotherapy: a randomized controlled trial. Complement Ther Med. 2009 Oct-Dec;17(5-6):274-80. doi: 10.1016/j.ctim.2009.06.004. Epub 2009 Oct 28.
- 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. This study is not recruiting at the moment.
David E Victorson, PhD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Audio Program in people with Prostate Cancer, run by Northwestern University.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implementation feasibility measured by enrollment rate (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT03852017, which also lists 33 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 6 May 2023.