Breast CancerNCT05180656

Feasibility of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors

A study testing Yoga Intervention in people with Breast Cancer and Breast Cancer Stage I, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
What is being tested?: Yoga Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteCanada
Study dates: 13 Dec 2021to 27 Jul 2022
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years of age
primary diagnosis of Stage I-IIIa breast cancer
completed primary treatment(s)
proficient in written and spoken English
access to the Internet and a computer with videoconferencing capabilities

Who cannot join

colour-blind since the objective cognitive tests require participants to distinguish between colours
regular yoga practice defined as ≥2 times/week
major cognitive disorder(s) or impairment(s) (score ≤21 on the Telephone Interview of Cognitive Status)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Faculty of Kinesiology and Physical Education
Toronto, Ontario, M5S2W6

Other trials in Canada

About this study

Official title: The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study

The purpose of this pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors.

Read the detailed description

Although up to 75% of breast cancer survivors (BCS) experience cancer-related cognitive impairment (CRCI), there are no proven treatments beyond symptom management. Exercise and yoga interventions for cancer survivors have been shown to be effective in improving other treatment-related side effects such as fatigue, quality of life (QoL), and psychological distress, but there remain several gaps in the exercise oncology literature regarding the optimal type and dose of exercise needed to mitigate CRCI. Specifically, no studies have evaluated the impact of yoga on CRCI using both self-report and objective cognitive measures. Further, no studies have evaluated the impact of a remotely-delivered yoga intervention on CRCI in breast cancer survivors.

Using a mixed-methods approach, this study will will begin to fill these gaps by evaluating the feasibility of a remotely-delivery yoga intervention on cancer-related cognitive impairment (CRCI), fatigue, and exercise levels in individuals diagnosed with breast cancer. The primary objective of this study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors. This study will inform future randomized controlled trials (RCTs) examining the impact of remotely-delivered yoga interventions, with the eventual goal of providing greater access to exercise programming for symptom management for breast cancer patients and survivors.

All aspects of the study, including the assessments and the yoga intervention will take place remotely through videoconferencing. Feasibility measures, including enrolment, adherence, and attrition rates, as well as adverse events and participant satisfaction, will be tracked and assessed throughout the intervention. Objectively-assessed cognitive function will be measured using the National Institutes of Health (NIH) Virtual Toolbox Cognitive Battery and the online PsyToolkit Task Switching Test. Self-reported cognitive function will be assessed using the Functional Assessment of Cancer Therapy(FACT)-Cognitive questionnaire. Self-reported fatigue will be assessed using the Revised-Piper Fatigue Scale (PFS). Self-reported exercise will be assessed using a modified version of the Godin Leisure Time Exercise questionnaire (GLTEQ). These assessments will be taken at baseline and post-intervention. Participants will be asked to participate in the yoga intervention for 8 weeks. The yoga intervention will consist of two 60-minute yoga classes each week, which will be taught by a certified yoga instructor. Following the intervention, a sub-sample of participants will be will be purposefully selected and asked to participate in semi-structured qualitative interviews to understand their experiences with the intervention and study.

Conditions: Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Being tested: Yoga Intervention
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Yoga InterventionBehavioural
The yoga intervention will consist of two 60-minute yoga classes each week, taught by a certified yoga instructor and delivered remotely through videoconferencing. Participants will be asked to participate in the intervention for 8 weeks.

Study groups in NCT05180656
Study group	Role	What they receive
Yoga Intervention Group	Experimental	All participants will be assigned to the yoga intervention group (single arm). Receives: Behavioral: Yoga Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Enrolment rate
Participant enrolment rate will be one measure of feasibility. This will be calculated as the number of participants who enrol in the intervention, divided by the total number of participants assessed for study eligibility.
Measured: From beginning to end of recruitment period, up to 6 months.
Adherence rate
Adherence rate, or participants' adherence to the intervention, will be one measure of feasibility. This will be calculated as the number of classes participants attend, divided by the number of classes participants are expected to attend throughout the intervention.
Measured: From beginning to end of intervention period, up to 6 months.
Attrition rate
Attrition rate, or participant drop-out, will be one measure of feasibility. This will be calculated as the number of participants who do not complete the intervention, divided by the number of participants enrolled at the post-intervention mark.
Measured: From beginning to end of intervention period, up to 6 months.
Adverse events
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the yoga classes.
Measured: From beginning to end of intervention period, up to 6 months.
Burden and satisfaction
Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1 = 'strongly disagree', 5 = 'strongly agree').
Measured: 8 weeks post-baseline

Secondary outcomes (5)

Self-reported cognitive function
Self-reported cognitive function will be assessed using the 37-item FACT-Cog (Version 3) questionnaire which asks participants about perceived cognitive impairments, comments from others, perceived cognitive abilities, and impact on quality of life. Participants will be asked to rate each item on a 5-point Likert scale (0 = 'never/not at all', 4 = 'several times a day/very much').
Measured: Baseline to 8 weeks post-baseline
Objectively-assessed cognitive function
Objectively-assessed cognitive function will be measured using the National Institutes of Health (NIH) Toolbox Virtual Cognitive battery to measure immediate and working memory, verbal learning, executive function, and language, and the PsyToolkit task switching test to measure executive function. These tests will be administered remotely to participants via an iPad and videoconferencing.
Measured: Baseline to 8 weeks post-baseline
Self-reported fatigue
Self-reported fatigue will be assessed using the Revised-Piper Fatigue Scale questionnaire which is a 27-item questionnaire that asks participants about the degree of their perceived fatigue. Participants will be asked to rate each item on a 10-point Likert scale (0 = 'none', 10 = 'very much')
Measured: Baseline to 8 weeks post-baseline
Self-reported exercise
Self-reported exercise will be assessed using a modified version of the Godin Leisure Time Exercise Questionnaire, which asks participants about the number of times/week and average duration spent in light, moderate, and vigorous exercise in a typical week (7 days) over the past month.
Measured: Baseline to 8 weeks post-baseline
Semi-structured qualitative interviews
The researcher will conduct semi-structured qualitative interviews over videoconferencing that will ask participants about their experience with the study and intervention, including enjoyment, potential barriers faced, and how they felt physically and cognitively during and after the intervention.
Measured: 8 weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 202127 Jul 2022

First posted6 Jan 2022
Study start13 Dec 2021
Primary completion27 Jul 2022
Study completion27 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by University of TorontoThe 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
Model description: Participants will participate in two 60-minute virtual yoga classes each week, delivered through videoconferencing for 8 weeks.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05180656
Sponsor's protocol ID: 41494
Status last verified: Jan 2023
First submitted: 4 Oct 2021
Last updated: 11 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ahles TA, Saykin AJ, McDonald BC, Li Y, Furstenberg CT, Hanscom BS, Mulrooney TJ, Schwartz GN, Kaufman PA. Longitudinal assessment of cognitive changes associated with adjuvant treatment for breast cancer: impact of age and cognitive reserve. J Clin Oncol. 2010 Oct 10;28(29):4434-40. doi: 10.1200/JCO.2009.27.0827. Epub 2010 Sep 13.
PubMed 20837957
Bernstein LJ, McCreath GA, Komeylian Z, Rich JB. Cognitive impairment in breast cancer survivors treated with chemotherapy depends on control group type and cognitive domains assessed: A multilevel meta-analysis. Neurosci Biobehav Rev. 2017 Dec;83:417-428. doi: 10.1016/j.neubiorev.2017.10.028. Epub 2017 Oct 29.
PubMed 29092778
Bhattacharyya KK, Andel R, Small BJ. Effects of yoga-related mind-body therapies on cognitive function in older adults: A systematic review with meta-analysis. Arch Gerontol Geriatr. 2021 Mar-Apr;93:104319. doi: 10.1016/j.archger.2020.104319. Epub 2020 Dec 7.
PubMed 33338831
Buffart LM, van Uffelen JG, Riphagen II, Brug J, van Mechelen W, Brown WJ, Chinapaw MJ. Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials. BMC Cancer. 2012 Nov 27;12:559. doi: 10.1186/1471-2407-12-559.
PubMed 23181734
Campbell KL, Zadravec K, Bland KA, Chesley E, Wolf F, Janelsins MC. The Effect of Exercise on Cancer-Related Cognitive Impairment and Applications for Physical Therapy: Systematic Review of Randomized Controlled Trials. Phys Ther. 2020 Mar 10;100(3):523-542. doi: 10.1093/ptj/pzz090.
PubMed 32065236
Carson JW, Carson KM, Porter LS, Keefe FJ, Shaw H, Miller JM. Yoga for women with metastatic breast cancer: results from a pilot study. J Pain Symptom Manage. 2007 Mar;33(3):331-41. doi: 10.1016/j.jpainsymman.2006.08.009.
PubMed 17349503
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488
Danhauer SC, Addington EL, Cohen L, Sohl SJ, Van Puymbroeck M, Albinati NK, Culos-Reed SN. Yoga for symptom management in oncology: A review of the evidence base and future directions for research. Cancer. 2019 Jun 15;125(12):1979-1989. doi: 10.1002/cncr.31979. Epub 2019 Apr 1.
PubMed 30933317
Danhauer SC, Griffin LP, Avis NE, Sohl SJ, Jesse MT, Addington EL, Lawrence JA, Messino MJ, Giguere JK, Lucas SL, Wiliford SK, Shaw E. Feasibility of implementing a community-based randomized trial of yoga for women undergoing chemotherapy for breast cancer. J Community Support Oncol. 2015 Apr;13(4):139-147. doi: 10.12788/jcso.0125.
PubMed 28713846
Derry HM, Jaremka LM, Bennett JM, Peng J, Andridge R, Shapiro C, Malarkey WB, Emery CF, Layman R, Mrozek E, Glaser R, Kiecolt-Glaser JK. Yoga and self-reported cognitive problems in breast cancer survivors: a randomized controlled trial. Psychooncology. 2015 Aug;24(8):958-66. doi: 10.1002/pon.3707. Epub 2014 Oct 21.
PubMed 25336068
Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655
Galantino ML, Greene L, Daniels L, Dooley B, Muscatello L, O'Donnell L. Longitudinal impact of yoga on chemotherapy-related cognitive impairment and quality of life in women with early stage breast cancer: a case series. Explore (NY). 2012 Mar-Apr;8(2):127-35. doi: 10.1016/j.explore.2011.12.001.
PubMed 22385567
Gothe NP, Kramer AF, McAuley E. The effects of an 8-week Hatha yoga intervention on executive function in older adults. J Gerontol A Biol Sci Med Sci. 2014 Sep;69(9):1109-16. doi: 10.1093/gerona/glu095. Epub 2014 Jul 14.
PubMed 25024234
Janelsins MC, Peppone LJ, Heckler CE, Kesler SR, Sprod LK, Atkins J, Melnik M, Kamen C, Giguere J, Messino MJ, Mohile SG, Mustian KM. YOCAS(c)(R) Yoga Reduces Self-reported Memory Difficulty in Cancer Survivors in a Nationwide Randomized Clinical Trial: Investigating Relationships Between Memory and Sleep. Integr Cancer Ther. 2016 Sep;15(3):263-71. doi: 10.1177/1534735415617021. Epub 2015 Nov 29.
PubMed 26621521
Komatsu H, Yagasaki K, Yamauchi H, Yamauchi T, Takebayashi T. A self-directed home yoga programme for women with breast cancer during chemotherapy: A feasibility study. Int J Nurs Pract. 2016 Jun;22(3):258-66. doi: 10.1111/ijn.12419. Epub 2015 Dec 7.
PubMed 26643264

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of a Remotely-Delivered Yoga Intervention on Cognitive Function in Breast Cancer Survivors: A Feasibility Study
ClinicalTrials.gov ID: NCT05180656
Acronym / sponsor ID: 41494
Conditions: Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of TorontoUniversity, hospital or other
Study start: 13 Dec 2021 (actual)
Primary completion: 27 Jul 2022 (actual)
Study completion: 27 Jul 2022 (actual)
First posted: 6 Jan 2022 (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 pilot study is to assess the feasibility of a remotely-delivered yoga intervention for breast cancer survivors.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants will participate in two 60-minute virtual yoga classes each week, delivered through videoconferencing for 8 weeks.

Arm	Type	Receives
Yoga Intervention Group	Experimental	Behavioral: Yoga InterventionAll participants will be assigned to the yoga intervention group (single arm).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥18 years of age
primary diagnosis of Stage I-IIIa breast cancer
completed primary treatment(s)
proficient in written and spoken English
access to the Internet and a computer with videoconferencing capabilities

Key exclusion criteria (3 listed)

colour-blind since the objective cognitive tests require participants to distinguish between colours
regular yoga practice defined as ≥2 times/week
major cognitive disorder(s) or impairment(s) (score ≤21 on the Telephone Interview of Cognitive Status)

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
Yoga InterventionThe yoga intervention will consist of two 60-minute yoga classes each week, taught by a certified yoga instructor and delivered remotely through videoconferencing. Participants will be asked to participate in the intervention for 8 weeks.	Behavioural	Yoga Intervention Group

Primary outcome

Enrolment rate
Time frame: From beginning to end of recruitment period, up to 6 months.
Participant enrolment rate will be one measure of feasibility. This will be calculated as the number of participants who enrol in the intervention, divided by the total number of participants assessed for study eligibility.
Adherence rate
Time frame: From beginning to end of intervention period, up to 6 months.
Adherence rate, or participants' adherence to the intervention, will be one measure of feasibility. This will be calculated as the number of classes participants attend, divided by the number of classes participants are expected to attend throughout the intervention.
Attrition rate
Time frame: From beginning to end of intervention period, up to 6 months.
Attrition rate, or participant drop-out, will be one measure of feasibility. This will be calculated as the number of participants who do not complete the intervention, divided by the number of participants enrolled at the post-intervention mark.
Adverse events
Time frame: From beginning to end of intervention period, up to 6 months.
Adverse events will be one measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury that occurs during the yoga classes.
Burden and satisfaction
Time frame: 8 weeks post-baseline
Burden and satisfaction scores will be one measure of feasibility. This will be assessed using a researcher-generated 15-item questionnaire that asks participants about their experience with the intervention and assessments. Participants will rate items using a 5-point Likert scale (1 = 'strongly disagree', 5 = 'strongly agree').

5 secondary outcomes

Self-reported cognitive function
Time frame: Baseline to 8 weeks post-baseline
Objectively-assessed cognitive function
Time frame: Baseline to 8 weeks post-baseline
Self-reported fatigue
Time frame: Baseline to 8 weeks post-baseline
Self-reported exercise
Time frame: Baseline to 8 weeks post-baseline
Semi-structured qualitative interviews
Time frame: 8 weeks post-baseline

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 11 Jan 2023.
Background: PubMed 20837957Ahles TA, Saykin AJ, McDonald BC, Li Y, Furstenberg CT, Hanscom BS, Mulrooney TJ, Schwartz GN, Kaufman PA. Longitudinal assessment of cognitive changes associated with adjuvant treatment for breast cancer: impact of age and cognitive reserve. J Clin Oncol. 2010 Oct 10;28(29):4434-40. doi: 10.1200/JCO.2009.27.0827. Epub 2010 Sep 13.
Background: PubMed 29092778Bernstein LJ, McCreath GA, Komeylian Z, Rich JB. Cognitive impairment in breast cancer survivors treated with chemotherapy depends on control group type and cognitive domains assessed: A multilevel meta-analysis. Neurosci Biobehav Rev. 2017 Dec;83:417-428. doi: 10.1016/j.neubiorev.2017.10.028. Epub 2017 Oct 29.
Background: PubMed 33338831Bhattacharyya KK, Andel R, Small BJ. Effects of yoga-related mind-body therapies on cognitive function in older adults: A systematic review with meta-analysis. Arch Gerontol Geriatr. 2021 Mar-Apr;93:104319. doi: 10.1016/j.archger.2020.104319. Epub 2020 Dec 7.
Background: PubMed 23181734Buffart LM, van Uffelen JG, Riphagen II, Brug J, van Mechelen W, Brown WJ, Chinapaw MJ. Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials. BMC Cancer. 2012 Nov 27;12:559. doi: 10.1186/1471-2407-12-559.
Background: PubMed 32065236Campbell KL, Zadravec K, Bland KA, Chesley E, Wolf F, Janelsins MC. The Effect of Exercise on Cancer-Related Cognitive Impairment and Applications for Physical Therapy: Systematic Review of Randomized Controlled Trials. Phys Ther. 2020 Mar 10;100(3):523-542. doi: 10.1093/ptj/pzz090.
Background: PubMed 17349503Carson JW, Carson KM, Porter LS, Keefe FJ, Shaw H, Miller JM. Yoga for women with metastatic breast cancer: results from a pilot study. J Pain Symptom Manage. 2007 Mar;33(3):331-41. doi: 10.1016/j.jpainsymman.2006.08.009.
Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
Background: PubMed 30933317Danhauer SC, Addington EL, Cohen L, Sohl SJ, Van Puymbroeck M, Albinati NK, Culos-Reed SN. Yoga for symptom management in oncology: A review of the evidence base and future directions for research. Cancer. 2019 Jun 15;125(12):1979-1989. doi: 10.1002/cncr.31979. Epub 2019 Apr 1.
Background: PubMed 28713846Danhauer SC, Griffin LP, Avis NE, Sohl SJ, Jesse MT, Addington EL, Lawrence JA, Messino MJ, Giguere JK, Lucas SL, Wiliford SK, Shaw E. Feasibility of implementing a community-based randomized trial of yoga for women undergoing chemotherapy for breast cancer. J Community Support Oncol. 2015 Apr;13(4):139-147. doi: 10.12788/jcso.0125.
Background: PubMed 25336068Derry HM, Jaremka LM, Bennett JM, Peng J, Andridge R, Shapiro C, Malarkey WB, Emery CF, Layman R, Mrozek E, Glaser R, Kiecolt-Glaser JK. Yoga and self-reported cognitive problems in breast cancer survivors: a randomized controlled trial. Psychooncology. 2015 Aug;24(8):958-66. doi: 10.1002/pon.3707. Epub 2014 Oct 21.
Background: PubMed 26978655Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
Background: PubMed 22385567Galantino ML, Greene L, Daniels L, Dooley B, Muscatello L, O'Donnell L. Longitudinal impact of yoga on chemotherapy-related cognitive impairment and quality of life in women with early stage breast cancer: a case series. Explore (NY). 2012 Mar-Apr;8(2):127-35. doi: 10.1016/j.explore.2011.12.001.
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.

Linda Trinh, PhD study director

University of Toronto, Faculty of Kinesiology and Physical Education

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga Intervention in people with Breast Cancer and Breast Cancer Stage I, run by University of Toronto at 1 site in Canada.

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 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: finished, as of the sponsor's last update on 11 Jan 2023. 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 Canada. 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 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?

Enrolment rate (time frame: From beginning to end of recruitment period, up to 6 months.). The study lists 5 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 NCT05180656, which also lists 26 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 11 Jan 2023.