CancerRESPONdNCT07024329
Implementing REmote SymPtom mOnitoring and maNagement (RESPONd)
A study testing Remote Symptom Monitoring and Management and Clinic Team Huddle in people with Cancer, run by University of Calgary at 4 sites in Canada.
Trial summary
The goal of this study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes. The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between appointments and receive tailored advice from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Remote Symptom Monitoring and Management and Clinic Team Huddle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,055 participants
- Where
- 4 sitesCanada
- Study dates
- 16 May 2025to 31 Mar 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
- Age ≥ 18
- Have cancer
- Receiving care in one of the participating clinics.
- Able to sign up for MyAHS Connect and consent.
- Have access to a digital device at home
- Able to complete their electronic PROs questionnaire without support from the clinic team on a weekly (patients on active treatment) or monthly (patients on follow-up) basis, for the duration of the intervention or until they are discharged from the clinic.
- Regular access to a telephone in order for the study nurse to call patients to provide symptom management support.
Who cannot join
- Patients with cognitive disabilities or who cannot reliably report symptoms independently.
- Patients not residing in Alberta, as government-issued ID is required to register for MyAHS Connect.
- Patients who do not have regular access to a telephone, as the study nurse needs to be able to call patients to provide symptom management support.
- Patients who do not speak English, or who do not have an English-speaking friend, family member, or caregiver to assist them, as the electronic PROs questionnaire is only available in English at this time.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 4N1
Chizoba Anyimukwu, 587-943-3556, chizoba.anyimukwu@ahs.ca
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Chizoba Anyimukwu, 587-943-3556, chizoba.anyimukwu@ahs.ca
- Not yet recruiting
High River Community Cancer Centre
High River, Alberta, T1V 1B3
Chizoba Anyimukwu, 587-943-3556, chizoba.anyimukwu@ahs.ca
- Recruiting
Central Alberta Cancer Centre
Red Deer, Alberta, T4N 6R2
Chizoba Anyimukwu, 587-943-3556, chizoba.anyimukwu@ahs.ca
About this study
Official title: Implementing REmote SymPtom mOnitoring and maNagement (RESPONd): Evaluating the Impact on Cancer Patients, System Efficiency, and Economic Outcomes
The goal of this study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes. The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between appointments and receive tailored advice from a study nurse. A second goal of this study is to examine the impact of electronic symptom monitoring on clinic efficiencies.
The main question it aims to answer is:
Read more
- What impact does implementing digitally enabled remote symptom monitoring and management (RESPONd) between ambulatory oncology visits have on patient outcomes and system efficiencies?
Participants will:
- Report their symptoms and concerns from home by completing the electronic symptom monitoring questionnaire.
- Discuss their symptoms and concerns with a study nurse.
- Provide feedback about their experience at important timepoints during the study.
- Participate as usual in ambulatory clinic appointments.
Read the detailed description
Rationale:
In recent years, cancer care has increasingly shifted from acute to ambulatory settings as a strategy to manage healthcare costs. While some emergency department (ED) visits are unavoidable due to the complexity of cancer-related issues, many could be prevented through timely symptom management and coordinated care in ambulatory oncology. The integration of Patient Reported Outcomes (PROs) into routine cancer care has been shown to reduce ED visits, enhance quality of life, and improve overall survival.
Within Cancer Care Alberta, PROs are routinely collected during clinic visits and electronically, using a standardized questionnaire that assesses common symptoms and supportive care needs experienced by cancer patients. Despite this, the use of electronic PROs data for real-time symptom management remains inconsistent, and there is currently no established workflow in Alberta for remote symptom monitoring. As a result, healthcare providers often lack advance insight into patients' symptoms prior to appointments.
Study Design:
The study is a stepped-wedge effectiveness-implementation type 1 hybrid design. RESPONd will be implemented over 1.5 years in six clinics, spanning tertiary, regional, and community cancer centres. Study nurses will monitor electronic PROs questionnaires completed between clinic visits and contact patients to provide personalized support. Collected electronic PROs information will also be utilized during weekly triage discussions in each clinic, where the route of care will be tailored for patients based on their symptom complexity. Participant quality of life will be measured at baseline, 3, and 6 months. Health care utilization compared to non-RESPONd patients will be evaluated. The implementation of this study will be evaluated using the RE-AIM framework, utilizing all constructs.
Following completion of the quantitative phase (stepped-wedge effectiveness-implementation type 1 hybrid design), a qualitative component will be conducted using semi-structured interviews with a subset of participants. This phase aims to explain and provide deeper insight into the quantitative results, including patient experiences, contextual factors influencing implementation, and perceived barriers and facilitators to intervention uptake.
Potential impact on practice:
The study will explore a person-centered, proactive approach to remote symptom management and the effects on patient experience, outcomes, and clinical teams. RESPONd represents an innovative opportunity to shift the model of care in oncology clinics to optimize efficiency and utilization of limited clinic resources and create a responsive care team that is ready and able to provide personalized symptom management and supportive care within the cancer journey.
- Conditions
- Cancer
- Being tested
- Remote Symptom Monitoring and Management, Clinic Team Huddle
- Keywords
- Patient Reported Outcomes, Quality of Life, Clinical Decision Making, Patient Reported Outcome Measures, Patient Experience, Health Service Utilization, Symptom Management, PROMs, PROs
- Medical subject headings
- Neoplasms, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Symptom Monitoring and ManagementOther
A study nurse will digitally monitor symptom complexity and provide symptom management between clinic visits. This will increase the frequency of collection and use of electronic PROs to provide responsive symptom management. Electronic PROs are collected digitally, and a complexity algorithm is used to flag patients with high symptom complexity. This will allow the study nurse to proactively manage symptoms in a timelier way.
Clinic Team HuddleOther
Support will be provided to clinic teams to implement a team huddle (team planning session) one week prior to clinics, to assess how additional electronic PROs data for patients participating in RESPONd impacts their ability to identify stable patients with low symptom complexity who could receive virtual care or Registered Nurse (RN) led clinic care.
| Study group | Role | What they receive |
|---|---|---|
| RESPONd | Experimental | Participants will be recruited and supported to complete electronic PROs questionnaires. Study nurses will monitor the electronic PROs completed between clinic visits and contact patients to provide personalized support. Receives: Other: Remote Symptom Monitoring and Management; Other: Clinic Team Huddle |
| Non-RESPONd | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
RESPONd participants will be asked to complete the Euro Quality of Life -EuroQol-5 Dimension 5 Level (EQ-5D-5L) questionnaire. This is a generic measure of QoL often used with cancer patients. Consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 5 levels (from no problems to extreme problems).
The responses form a 5-digit health state profile (e.g., 11111 = perfect health).
These profiles are converted into a single summary index value (utility score) using a Canadian-specific value set derived through the Time Trade-Off (TTO) method.
Utility Index Score Range (Canada):
Minimum: Less than 0 (indicating a health state considered worse than death) Maximum: 1 (indicating full or perfect health)
Measured: Baseline, 3 months and 6 months
Self-rated health
RESPONd participants will also be asked to complete the Euro Quality of Life (EuroQol) Visual Analog Scale (EQ-VAS) which assesses self-rated health on a vertical scale where respondents rate their overall health on the day of the survey.
Range: 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Baseline, 3 months and 6 months
Rate of Emergency department (ED) visits
Frequency of ED usage rate per patient and per 1000
Measured: Baseline through study completion, an average of 18 months
Rate of Hospital admissions
This will be measured by calculating number of inpatient stays per 1,000 people
Measured: Baseline through study completion, an average of 18 months
Economic outcome measure - Incremental cost-effectiveness ratio (ICER)
The ICER ratio assesses cost-effectiveness and provides an estimate of the incremental cost for one additional unit of health outcome. To assess the effectiveness of the intervention, the ICER ratio per ED visit and hospital admission avoided will be applied to assess the number of visits avoided due to RESPONd. The number of ED visits and hospital admissions are also included as these are required to calculate the ICER ratio per visit type avoided.
Measured: Baseline through study completion, an average of 18 months
Economic outcome measures - Quality adjusted life years (QUALYs)
Quality adjusted life years (QUALYs): A quality-adjusted life year is a summary measure used to evaluate the value of medical interventions in terms of the quality and quantity of life they produce. It combines both the duration of life and the health-related quality of life into a single index number. ICERs and net monetary benefit will be used to report QUALYs.
Measured: Baseline through study completion, an average of 18 months
Secondary outcomes (5)
Clinic outcome measure - Patient scheduling and clinic visit type
Information on the number, length, and type of visit (in-person or virtual; portal, telephone, email, or Zoom; Registered Nurse-led (RN-led) or Medical Oncologist-led (MO-led) will be obtained from the administrative database to assess clinical efficiency.
Measured: Baseline through study completion, an average of 18 months
Clinic outcome measure - Number of patients that required additional intervention
The number of patients that required additional intervention after a clinic visit to determine if the triaged care was sufficient. The study nurse will also be required to keep track of the number of times needed to contact the medical oncologist (MO) address out of scope matters to also assess clinical efficiency.
Measured: Baseline through study completion, an average of 18 months
Clinic outcome measure - Number of times the study nurse needed to contact the Medical Oncologist
The study nurse will keep track of the number of times needed to contact the Medical Oncologist (MO) to address out of scope matters to assess clinical efficiency.
Measured: Baseline through study completion, an average of 18 months
Patient experience measure
To understand patient perspectives, a web-based questionnaire will be disseminated to RESPONd participants via REDCap. Thirteen items on the patient experience measure are adapted from the Your Voice Matters patient-reported experience measure, developed by Cancer Care Ontario. Participants will be asked to rate each care experience using a three-point Likert scale:
- Yes, completely
- Yes, somewhat
- No.
One question asks participants to measure the overall quality of all of their cancer care in the past 6 months using a five-point Likert scale:
- Poor
- Fair
- Good
- Very good
- Excellent
Measured: At baseline, and 6 months/end of the intervention
Staff experience measure
A researcher-developed web-based questionnaire designed to capture feedback from oncology clinic staff on the implementation and impact of the RESPONd program and the weekly team huddle.
It includes questions on staff roles, clinic location, and perceived impacts on team collaboration, workflow efficiency, and the integration of patient data such as electronic PROs. The survey specifically evaluates how having access to weekly electronic PROs and participating in structured team huddles affects clinical decision-making and communication.
Oncology clinic staff will be asked to rate each experience using a four-point Likert scale:
- Agree
- Somewhat Agree
- Somewhat disagree
- Disagree
Measured: Quarterly - from baseline through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,055 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, Alberta Innovates Health Solutions
- Responsible party
- Principal investigator, Linda Watson, University of Calgary
- Investigators
- Linda Watson, RN, PhD, Principal investigator, Cancer Care Alberta, Alberta Health ServicesMarni Armstrong, PhD, Study director, Cancer Care Alberta, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024329
- Sponsor's protocol ID
- HREBA.CC-24-0138
- Acronym
- RESPONd
- Status last verified
- Apr 2026
- First submitted
- 9 May 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watson L, Qi S, Link C, DeIure A, Afzal A, Barbera L. Patient-Reported Symptom Complexity and Acute Care Utilization Among Patients With Cancer: A Population-Based Study Using a Novel Symptom Complexity Algorithm and Observational Data. J Natl Compr Canc Netw. 2023 Feb;21(2):173-180. doi: 10.6004/jnccn.2022.7087.
PubMed 36791760
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing REmote SymPtom mOnitoring and maNagement (RESPONd): Evaluating the Impact on Cancer Patients, System Efficiency, and Economic Outcomes
- ClinicalTrials.gov ID
- NCT07024329
- Acronym / sponsor ID
- RESPONd / HREBA.CC-24-0138
- Conditions
- Cancer
- Keywords
- Patient Reported Outcomes, Quality of Life, Clinical Decision Making, Patient Reported Outcome Measures, Patient Experience, Health Service Utilization, Symptom Management, PROMs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,055 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services, Alberta Innovates Health Solutions
- Study start
- 16 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jun 2025 (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 study is to understand if the implementation of a remote symptom monitoring and management program improves outcomes. The program will provide patients the opportunity to complete electronic Patient Reported Outcomes (PROs) questionnaires from home between appointments and receive tailored advice from a study nurse. A second goal of this study is to examine the impact of electronic symptom monitoring on clinic efficiencies.
The main question it aims to answer is:
- What impact does implementing digitally enabled remote symptom monitoring and management (RESPONd) between ambulatory oncology visits have on patient outcomes and system efficiencies?
Participants will:
- Report their symptoms and concerns from home by completing the electronic symptom monitoring questionnaire.
- Discuss their symptoms and concerns with a study nurse.
- Provide feedback about their experience at important timepoints during the study.
- Participate as usual in ambulatory clinic appointments.
Detailed description
Rationale:
In recent years, cancer care has increasingly shifted from acute to ambulatory settings as a strategy to manage healthcare costs. While some emergency department (ED) visits are unavoidable due to the complexity of cancer-related issues, many could be prevented through timely symptom management and coordinated care in ambulatory oncology. The integration of Patient Reported Outcomes (PROs) into routine cancer care has been shown to reduce ED visits, enhance quality of life, and improve overall survival.
Within Cancer Care Alberta, PROs are routinely collected during clinic visits and electronically, using a standardized questionnaire that assesses common symptoms and supportive care needs experienced by cancer patients. Despite this, the use of electronic PROs data for real-time symptom management remains inconsistent, and there is currently no established workflow in Alberta for remote symptom monitoring. As a result, healthcare providers often lack advance insight into patients' symptoms prior to appointments.
Study Design:
The study is a stepped-wedge effectiveness-implementation type 1 hybrid design. RESPONd will be implemented over 1.5 years in six clinics, spanning tertiary, regional, and community cancer centres. Study nurses will monitor electronic PROs questionnaires completed between clinic visits and contact patients to provide personalized support. Collected electronic PROs information will also be utilized during weekly triage discussions in each clinic, where the route of care will be tailored for patients based on their symptom complexity. Participant quality of life will be measured at baseline, 3, and 6 months. Health care utilization compared to non-RESPONd patients will be evaluated. The implementation of this study will be evaluated using the RE-AIM framework, utilizing all constructs.
Following completion of the quantitative phase (stepped-wedge effectiveness-implementation type 1 hybrid design), a qualitative component will be conducted using semi-structured interviews with a subset of participants. This phase aims to explain and provide deeper insight into the quantitative results, including patient experiences, contextual factors influencing implementation, and perceived barriers and facilitators to intervention uptake.
Potential impact on practice:
The study will explore a person-centered, proactive approach to remote symptom management and the effects on patient experience, outcomes, and clinical teams. RESPONd represents an innovative opportunity to shift the model of care in oncology clinics to optimize efficiency and utilization of limited clinic resources and create a responsive care team that is ready and able to provide personalized symptom management and supportive care within the cancer journey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESPONd | Experimental | Other: Remote Symptom Monitoring and Management, Other: Clinic Team HuddleParticipants will be recruited and supported to complete electronic PROs questionnaires. Study nurses will monitor the electronic PROs completed between clinic visits and contact patients to provide personalized support. |
| Non-RESPONd | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18
- Have cancer
- Receiving care in one of the participating clinics.
- Able to sign up for MyAHS Connect and consent.
- Have access to a digital device at home
Key exclusion criteria (4 listed)
- Patients with cognitive disabilities or who cannot reliably report symptoms independently.
- Patients not residing in Alberta, as government-issued ID is required to register for MyAHS Connect.
- Patients who do not have regular access to a telephone, as the study nurse needs to be able to call patients to provide symptom management support.
- Patients who do not speak English, or who do not have an English-speaking friend, family member, or caregiver to assist them, as the electronic PROs questionnaire is only available in English at this time.
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 |
|---|---|---|
| Remote Symptom Monitoring and ManagementA study nurse will digitally monitor symptom complexity and provide symptom management between clinic visits. This will increase the frequency of collection and use of electronic PROs to provide responsive symptom management. Electronic PROs are collected digitally, and a complexity algorithm is used to flag patients with high symptom complexity. This will allow the study nurse to proactively manage symptoms in a timelier way. | Other | RESPONd |
| Clinic Team HuddleSupport will be provided to clinic teams to implement a team huddle (team planning session) one week prior to clinics, to assess how additional electronic PROs data for patients participating in RESPONd impacts their ability to identify stable patients with low symptom complexity who could receive virtual care or Registered Nurse (RN) led clinic care. | Other | RESPONd |
Primary outcome
Quality of Life (QoL)
Time frame: Baseline, 3 months and 6 months
RESPONd participants will be asked to complete the Euro Quality of Life -EuroQol-5 Dimension 5 Level (EQ-5D-5L) questionnaire. This is a generic measure of QoL often used with cancer patients. Consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with 5 levels (from no problems to extreme problems). The responses form a 5-digit health state profile (e.g., 11111 = perfect health). These profiles are converted into a single summary index value (utility score) using a Canadian-specific value set derived through the Time Trade-Off (TTO) method. Utility Index Score Range (Canada): Minimum: Less than 0 (indicating a health state considered worse than death) Maximum: 1 (indicating full or perfect health)
Self-rated health
Time frame: Baseline, 3 months and 6 months
RESPONd participants will also be asked to complete the Euro Quality of Life (EuroQol) Visual Analog Scale (EQ-VAS) which assesses self-rated health on a vertical scale where respondents rate their overall health on the day of the survey. Range: 0 (worst imaginable health) to 100 (best imaginable health).
Rate of Emergency department (ED) visits
Time frame: Baseline through study completion, an average of 18 months
Frequency of ED usage rate per patient and per 1000
Rate of Hospital admissions
Time frame: Baseline through study completion, an average of 18 months
This will be measured by calculating number of inpatient stays per 1,000 people
Economic outcome measure - Incremental cost-effectiveness ratio (ICER)
Time frame: Baseline through study completion, an average of 18 months
The ICER ratio assesses cost-effectiveness and provides an estimate of the incremental cost for one additional unit of health outcome. To assess the effectiveness of the intervention, the ICER ratio per ED visit and hospital admission avoided will be applied to assess the number of visits avoided due to RESPONd. The number of ED visits and hospital admissions are also included as these are required to calculate the ICER ratio per visit type avoided.
Economic outcome measures - Quality adjusted life years (QUALYs)
Time frame: Baseline through study completion, an average of 18 months
Quality adjusted life years (QUALYs): A quality-adjusted life year is a summary measure used to evaluate the value of medical interventions in terms of the quality and quantity of life they produce. It combines both the duration of life and the health-related quality of life into a single index number. ICERs and net monetary benefit will be used to report QUALYs.
5 secondary outcomes
Clinic outcome measure - Patient scheduling and clinic visit type
Time frame: Baseline through study completion, an average of 18 months
Clinic outcome measure - Number of patients that required additional intervention
Time frame: Baseline through study completion, an average of 18 months
Clinic outcome measure - Number of times the study nurse needed to contact the Medical Oncologist
Time frame: Baseline through study completion, an average of 18 months
Patient experience measure
Time frame: At baseline, and 6 months/end of the intervention
Staff experience measure
Time frame: Quarterly - from baseline through study completion, an average of 18 months
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 30 Apr 2026.
- Results publication: PubMed 36791760Watson L, Qi S, Link C, DeIure A, Afzal A, Barbera L. Patient-Reported Symptom Complexity and Acute Care Utilization Among Patients With Cancer: A Population-Based Study Using a Novel Symptom Complexity Algorithm and Observational Data. J Natl Compr Canc Netw. 2023 Feb;21(2):173-180. doi: 10.6004/jnccn.2022.7087.
- 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.
Linda Watson, RN, PhD principal investigator
Cancer Care Alberta, Alberta Health Services
Marni Armstrong, PhD study director
Cancer Care Alberta, Alberta Health Services
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Symptom Monitoring and Management and Clinic Team Huddle in people with Cancer, run by University of Calgary at 4 sites 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 7 inclusion and 4 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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 Chizoba Anyimukwu, MPH, DrPH (587-943-3556, chizoba.anyimukwu@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: Baseline, 3 months and 6 months). The study lists 6 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 NCT07024329, which also lists 1 linked publication.
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 30 Apr 2026.