Breast Cancer FemaleNCT03915548

Optimizing Functional Recovery of Breast Cancer Survivors

A study testing The Behavioral Activation/ Problem Solving Intervention in people with Breast Cancer Female, run by MGH Institute of Health Professions at 2 sites in United States.

Completed

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

Official record

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Trial summary

This study is a randomized controlled trial (RCT) to test the efficacy of a Behavioral Activation and Problem Solving (BA/PS) approach to improving activity participation over time as compared to an attention control condition within a sample of 300 breast cancer survivors reporting reduced activity participation… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female
What is being tested?: The Behavioral Activation/ Problem Solving Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 303 participants
Where: 2 sitesUnited States
Study dates: 28 Aug 2019to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age of 18 years or older.
Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale).
Females diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or chemotherapy with curative intent and absence of disease recurrence

Who cannot join

Non-English speaking.
Non-correctable hearing loss.
Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294-1210
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors

Read the detailed description

Assessments will be administered via telephone by a research assistant blind to group assignment. Participants will complete outcome assessments upon enrollment (T1) and at 8 weeks (T2), 20 weeks (T3) and 44 weeks (T4) later. The T2 assessment captures the short-term outcomes of the most intensive part of the intervention (i.e., after six weekly sessions). The T3 assessment will capture the short-term outcomes at the end of the full intervention. The T4 assessment explores the sustained effect of BA/PS (six months after BA/PS ends). The study aim is to test whether the BA/PS intervention affects the "slope" of functional recovery over time. With the longitudinal data, the investigators will also be able to explore the pace of improvement and whether the two groups differ at these clinically relevant time points.

Conditions: Breast Cancer Female
Being tested: The Behavioral Activation/ Problem Solving Intervention, Attention Control Condition

What participants receive

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

The Behavioral Activation/ Problem Solving InterventionBehavioural
The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
Attention Control ConditionBehavioural
The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.

Study groups in NCT03915548
Study group	Role	What they receive
The Behavioral Activation/ Problem Solving Intervention	Experimental	BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model. Receives: Behavioral: The Behavioral Activation/ Problem Solving Intervention
Attention Control Condition	Active comparator	Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition). Receives: Behavioral: Attention Control Condition

What is being measured

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

Participation Satisfaction in Social Roles and Activities: PROMIS
The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).
Measured: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Participation Ability in Social Roles and Activities
The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).
Measured: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Productivity
Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS).
Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity.
Measured: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Work Productivity
The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.
Measured: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

Secondary outcomes (1)

Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life.
Measured: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

Timeline

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

28 Aug 201931 Mar 2024

First posted16 Apr 2019
Study start28 Aug 2019
Primary completion30 Apr 2023
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
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: The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attention
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915548
Sponsor's protocol ID: 2021P002871
Other IDs: 1R01CA225792-01A1
Status last verified: May 2024
First submitted: 3 Apr 2019
Last updated: 3 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lyons KD, Wechsler SB, Ejem DB, Stevens CJ, Azuero A, Khalidi S, Hegel MT, Dos Anjos SM, Codini ME, Chamberlin MD, Morency JL, Coffee-Dunning J, Thorp KE, Cloyd DZ, Goedeken S, Newman R, Muse C, Rocque G, Keene K, Pisu M, Echols J, Bakitas MA. Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242478. doi: 10.1001/jamanetworkopen.2024.2478.
PubMed 38517442
Stevens CJ, Hegel MT, Bakitas MA, Bruce M, Azuero A, Pisu M, Chamberlin M, Keene K, Rocque G, Ellis D, Gilbert T, Morency JL, Newman RM, Codini ME, Thorp KE, Dos Anjos SM, Cloyd DZ, Echols J, Milford AN, Ingram SA, Davis J, Lyons KD. Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors. BMJ Open. 2020 Feb 13;10(2):e036864. doi: 10.1136/bmjopen-2020-036864.
PubMed 32060166

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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All Breast Cancer Female trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors
ClinicalTrials.gov ID: NCT03915548
Acronym / sponsor ID: 2021P002871
Conditions: Breast Cancer Female
Study type: Interventional
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: MGH Institute of Health ProfessionsUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 28 Aug 2019 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 16 Apr 2019 (actual)
Results: Posted 3 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attention

Arm	Type	Receives
The Behavioral Activation/ Problem Solving Intervention	Experimental	Behavioral: The Behavioral Activation/ Problem Solving InterventionBA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
Attention Control Condition	Active comparator	Behavioral: Attention Control ConditionInvestigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of "homework" between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).

Who may qualify

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

Key inclusion criteria (3 listed)

Age of 18 years or older.
Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale).
Females diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or chemotherapy with curative intent and absence of disease recurrence

Key exclusion criteria (4 listed)

Non-English speaking.
Non-correctable hearing loss.
Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.

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
The Behavioral Activation/ Problem Solving InterventionThe interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.	Behavioural	The Behavioral Activation/ Problem Solving Intervention
Attention Control ConditionThe interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.	Behavioural	Attention Control Condition

Primary outcome

Participation Satisfaction in Social Roles and Activities: PROMIS
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).
Participation Ability in Social Roles and Activities
Time frame: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).
Productivity
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity.
Work Productivity
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.

1 secondary outcome

Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.

Results and safety

Results posted to the registry on 3 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Behavioral Activation/ Problem Solving Intervention	144	118
Attention Control Condition	140	113

Primary outcome: Participation Satisfaction in Social Roles and Activities: PROMIS

Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.. Mean (Standard Error). Unit: T-score

Measure	The Behavioral Activation/ Problem Solving Intervention n = 144	Attention Control Condition n = 140
Week 0	45.75 (.43)	46 (.44)
Week 8	48.09 (.47)	47.61 (.46)
Week 20	50.47 (.47)	49.81 (.47)
Week 44	50.85 (.48)	51.39 (.49)

The Behavioral Activation/ Problem Solving Intervention vs Attention Control Condition: p = .54, Mixed Models Analysis

Population analysed: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.

Primary outcome: Participation Ability in Social Roles and Activities

Time frame: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.. Mean (Standard Error). Unit: T-scores

Measure	The Behavioral Activation/ Problem Solving Intervention n = 144	Attention Control Condition n = 140
Week 0	43.55 (.4)	43.48 (.41)
Week 8	45.55 (.43)	44.95 (.43)
Week 20	47.27 (.43)	46.44 (.43)
Week 44	47.43 (.44)	48.63 (.45)

The Behavioral Activation/ Problem Solving Intervention vs Attention Control Condition: p = .09, Mixed Models Analysis

Population analysed: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.

Primary outcome: Productivity

Measure	The Behavioral Activation/ Problem Solving Intervention n = 144	Attention Control Condition n = 140
Week 0	1.32 (.17)	1.15 (.15)
Week 8	1.03 (.14)	.91 (.12)
Week 20	1.22 (.16)	.87 (.12)
Week 44	.88 (.13)	.76 (.11)

The Behavioral Activation/ Problem Solving Intervention vs Attention Control Condition: p = .55, Mixed Models Analysis

Population analysed: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.

Primary outcome: Work Productivity

Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.. Mean (Standard Error). Unit: score on a scale

Measure	The Behavioral Activation/ Problem Solving Intervention n = 144	Attention Control Condition n = 140
Week 0	34.7 (1.58)	34.15 (1.6)
Week 8	27.87 (1.71)	25.35 (1.67)
Week 20	25.13 (1.73)	23.57 (1.69)
Week 44	22.79 (1.73)	21.14 (1.75)

The Behavioral Activation/ Problem Solving Intervention vs Attention Control Condition: p = .99, Mixed Models Analysis

Population analysed: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 44 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Behavioral Activation/ Problem Solving Intervention	0 of 144 (0%)	0 of 144 (0%)	0 of 144
Attention Control Condition	0 of 140 (0%)	0 of 140 (0%)	0 of 140

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38517442Lyons KD, Wechsler SB, Ejem DB, Stevens CJ, Azuero A, Khalidi S, Hegel MT, Dos Anjos SM, Codini ME, Chamberlin MD, Morency JL, Coffee-Dunning J, Thorp KE, Cloyd DZ, Goedeken S, Newman R, Muse C, Rocque G, Keene K, Pisu M, Echols J, Bakitas MA. Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242478. doi: 10.1001/jamanetworkopen.2024.2478.
Derived from this study: PubMed 32060166Stevens CJ, Hegel MT, Bakitas MA, Bruce M, Azuero A, Pisu M, Chamberlin M, Keene K, Rocque G, Ellis D, Gilbert T, Morency JL, Newman RM, Codini ME, Thorp KE, Dos Anjos SM, Cloyd DZ, Echols J, Milford AN, Ingram SA, Davis J, Lyons KD. Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors. BMJ Open. 2020 Feb 13;10(2):e036864. doi: 10.1136/bmjopen-2020-036864.
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.

Kathleen Lyons, ScD principal investigator

MGH Institute of Health Professionals

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

Questions about this trial

What is this clinical trial studying?

A study testing The Behavioral Activation/ Problem Solving Intervention in people with Breast Cancer Female, run by MGH Institute of Health Professions 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 3 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: finished, as of the sponsor's last update on 3 May 2024. 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?

Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participation Satisfaction in Social Roles and Activities: PROMIS (time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.). 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 NCT03915548, which also lists 2 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 May 2024.