Breast CancerNCT05645471
Together After Cancer
A study testing Together After Cancer in people with Breast Cancer and Quality of Life, run by University of South Florida at 3 sites in United States.
Trial summary
To evaluate the impact of an adapted online, self-help relationship intervention (supplemented with brief coach calls) for survivors of breast cancer and their partners. Couples will be randomized to receive either the online intervention (Together after Cancer) or usual care (UC) and assessed at baseline, end of the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Quality of Life, Communication
- What is being tested?
- Together After Cancer
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2023to 1 Aug 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 years of age and older
- Self-identify as Latina/Hispanic
- Spanish or English speaker
- Primary diagnosis of breast cancer in the last ten years
- Completed initial treatment
- Be married or in a committed relationship of six months duration or longer
Show all 16Show fewer
- Willingness to be randomized and followed for approximately 5 months
- Access to the internet or a smartphone, tablet, or computer
- Be 18 years of age or older
- Be married or in a committed relationship of six months duration or longer with a Latina Breast Cancer Survivor diagnosed who was diagnosed with breast cancer in the last ten years
- Willingness to be randomized and followed for approximately 5 months
- Access to the internet or a smartphone, tablet, or computer
- Couples will be eligible to participate if they also meet the following:
- Meet the inclusion criteria listed above for Latina Breast Cancer Survivors and Intimate Partners
- Both partners are willing to participate in the study
- Additionally, to be eligible, the Latina Breast Cancer Survivors must reside in Florida
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sylvester Comprehensive Cancer Center and University of Miami
Miami, Florida, 33136
AdventHealth
Orlando, Florida, 32803
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Comparative Effectiveness of Together After Cancer Among Breast Cancer Survivors and Their Intimate Partners
To evaluate the impact of an adapted online, self-help relationship intervention (supplemented with brief coach calls) for survivors of breast cancer and their partners. Couples will be randomized to receive either the online intervention (Together after Cancer) or usual care (UC) and assessed at baseline, end of the program, and 3 months after randomization.
Read the detailed description
As the fastest-growing and largest ethnic minority group, projections indicate that 128 million Latinos will reside in the United States by 2050; with one in three Latinos receiving a diagnosis of cancer during his/her lifetime. Latino cancer survivors have a lower quality of life, experience distress due to strained spousal and family relationships, have poorer physical health, and have more depression, pain, and fatigue when compared to non-Latinos. In addition, emotional and mental well-being between Latino survivors and their partners is related, with partners also experiencing increased distress and physical symptoms. Research has shown that couples-based psychosocial programs improve the quality of life and emotional and physical health of cancer survivors and their partners. Yet, much of the in this area has focused on non-Hispanic Whites. Features of Latino culture may influence and interact with social, psychosocial, health care, and clinical factors that influence cancer-related outcomes. Our goal is to add to this literature and develop a program for Latina breast cancer survivors and their partners that is culturally meaningful and relevant and responds to their needs and concerns.
Specifically, investigators plan to culturally adapt a widely-available and effective online couple intervention, OurRelationship (ORI), for Latina breast cancer survivors and their intimate partners. The online OR program - which can be done on a smartphone, tablet, or computer - was developed to serve as an online tool to help couples solve a specific relationship problem they selected. Investigators will adapt the OR program to be useful for Latina breast cancer survivors and their intimate partners using feedback from focus groups with patients, community partners, and research advisors. Once investigators have completed our adaptation, the plan to test the impact of the adapted program, Together after Cancer, using a type of study called a randomized controlled trial where participants will be randomly allocated to either receive the culturally adapted intervention or usual care. Investigators are interested in learning if couples in the group that are assigned to the intervention program report changes in their relationship functioning, psychological functioning (depression, anxiety, and perceived stress), and cancer-related quality of life (pain, fatigue, body image, and quality of life) compared to couples who are assigned to the UC group.
Through this comparative study, investigators expect to establish effective strategies that can be implemented in clinic and community settings to improve psychological functioning, relationship functioning, and quality of life. Investigators are enthusiastic about the potential for the intervention program to easily reach cancer Latina survivors around the nation, due to the online format and ease of access from any location. Throughout the project, investigators will continue to engage our local partners to ensure that the study procedures and outcomes are meaningful to all stakeholders.
Investigators are using patient-centered approaches to offer a culturally relevant web-based program that cancer survivors and their partners can access from the comfort of their homes.
- Conditions
- Breast Cancer, Quality of Life, Communication
- Being tested
- Together After Cancer
- Keywords
- Breast Cancer, Latino, Couples,
- Medical subject headings
- Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together After CancerBehavioural
This is an online couples intervention for Latina breast cancer survivors and their intimate partners.
| Study group | Role | What they receive |
|---|---|---|
| Together After Cancer Intervention | Experimental | Couples randomized into the intervention will participate in the program which is approximately 8-10 hours of web-based online content to be delivered over the course of 5-8 weeks. The online program can be done on a smartphone, tablet, or computer. In this program, partners complete the majority of the program on their own (to make it more flexible) and come together for 2-3 key conversations with their partner. In addition to the online content, couples will receive up to 100 minutes of scheduled research check-in/coaching calls from a research assistant to check-in. These coach calls will occur via a video chat via Zoom or, if not possible given a couple's technology limitations, over the phone. The coach calls serve several purposes: a) helping couples stay accountable to staying on the recommended schedule of activity completion; b) addressing any technical or program questions the couple has; and c) collecting research data as couples move through the program. Receives: Behavioral: Together After Cancer |
| Usual Care | No intervention | Participants randomized into UC, will consist of primary referral sources for breast cancer survivorship. At AdventHealth, Moffitt, and Sylvester Cancer centers, usual care consists of screening items assessing relationship/intimacy issues as a practical need. If these items are endorsed, referrals are provided to supportive oncology. At Sylvester, the Cancer Support Services offers caregiver support groups, "mental well-being" services (i.e., individual therapy), and an online support community for patients, caregivers, and survivors. At Moffitt, Support Services offers psychotherapy, support groups for patients, support groups for family/caregivers of cancer patients, and a program to help patients talk with their children about their diagnosis. At AdventHealth, patients are offered referrals to social services and psychoeducational programs like HEAL. However, none of the sites have services designed to focus on issues specific to patients' romantic relationships. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points.
The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients which focuses on physical, social, emotional, functional well-being as well as a breast-cancer subscale. Each question is rated on a four-point scale from 0=Not at all to 4=Very Much. The scale has an internal consistency of an α=.90, with subscale alpha coefficients ranging from .63 to .86.
Measured: Baseline, 2 and 5 month
Evaluate the changes in the satisfaction of the relationship between couples who are married across the pre to post to follow-up measurement time points.
The Couples Satisfaction Index (CSI) is a 32- item instrument assess one's satisfaction in a relationship which assess the presence of problems between individuals and the intensity of such problems. Each question is rated on a six-point scale from 0=Extremely Unhappy to 6=Perfect. The scale as an internal consistency α=0.92.
Measured: Baseline, 2 and 5 month
Secondary outcomes (10)
Evaluate the changes in the cancer-related body image of the breast cancer survivor across the pre to post to follow-up measurement time points.
The Body Image Scale is a 10-item measure developed to measure cognitive, affective, and evaluative variables of an individual's concept of body image and reflects relatively time-stable physical aspects, rather than current physical conditions. Each question is rated on a four-point scale from 1=Not at all to 4=Very much. The scale has an internal consistency is α=.90.
Measured: Baseline, 2 and 5 month
Evaluate the changes in cancer-related fatigue of the breast cancer across the pre to post to follow-up measurement time points.
The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue is a 7-item scale that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Each question is rated on a four-point scale from 1=Not at all to 4=Very much. The scale has an internal consistency is α=0.79.
Measured: Baseline, 2 and 5 month
Evaluate changes in the quality of life among the intimate partner across the pre to post to follow-up measurement time points.
The Functional Assessment of Cancer Therapy-General Pop. (FACT-GP) a shortened, 21-item that assess the perceived levels of health-related quality of life in the partner. Each question is rated on a five-point scale from 0=Not at all to 4=Very much. The scale has an internal consistency is α=0.89.
Measured: Baseline, 2 and 5 month
Evaluate changes in emotional distress-depression among breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
The PROMIS: Emotional Distress-Depression is an 8-item survey related to depressed mood in the past 7 days. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is α=0.97.
Measured: Baseline, 2, 5 month
Evaluate changes in emotional distress-anxiety among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
The PROMIS: Emotional Distress - Anxiety is a 6-item survey that assess self-reported fear, anxious misery, hyperarousal and somatic symptoms related to arousal. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is α=0.96.
Measured: Baseline, 2, 5 month
Evaluate changes in stress among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
The Perceived Stress Scale (PSS) is a 10-item that measures the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Each question is rated on a five-point scale from 0=never to 4 very often. The internal consistency is α=0.74.
Measured: Baseline, 2, 5 month
Evaluate changes in feeling cared and valued as a person among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
The PROMIS: Emotional Support is a 4-item that assess perceived feelings of being cared and valued as a person; having confidant relationships. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is α=0.98.
Measured: Baseline, 2, 5 month
Evaluate changes in supportive communication among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
The Dyadic Coping Inventory is a 37-item instrument designed to measure perceived communication and dyadic coping (supportive, delegated, negative, and joint) that occurs in close relationships when one or both partners are stressed. The internal consistency is α=0.86.
Measured: Baseline, 2, 5 month
Evaluate changes in negative communication between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
The Conflictual Communication Index is a 7-item measure developed to assess negative communication. Participants were asked to report how often communication conflict occurred during the past month on a Likert-type scale from 1=Never to 4= Often. The internal consistency is α=0.89.
Measured: Baseline, 2, 5 month
Evaluate changes in intimacy between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
The Personal Assessment of Intimacy in Relationships (PAIR) is a 6-item measure of that assesses comfort, intimacy, and satisfaction with sexual relationship of a couple. Each question is rated on a five-point scale from 1=Very rarely to 5=Very often. The internal consistency is α=0.86.
Measured: Baseline, 2, 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study aims to test the impact of the adapted Together After Cancer intervention using a cluster randomized controlled trial (cRCT), with individuals nested within couples and randomization occurring at the couple level to see if it is more effective than usual care (UC).
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, University of Miami Sylvester Comprehensive Cancer Center, AdventHealth, University of Central Florida
- Responsible party
- Principal investigator, Dinorah Martinez Tyson, PhD, MPH, MA, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645471
- Sponsor's protocol ID
- 004181
- Other IDs
- AD-2020C3-21171
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Together After Cancer Among Breast Cancer Survivors and Their Intimate Partners
- ClinicalTrials.gov ID
- NCT05645471
- Acronym / sponsor ID
- 004181
- Conditions
- Breast Cancer, Quality of Life, Communication
- Keywords
- Breast Cancer, Latino, Couples,
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, University of Miami Sylvester Comprehensive Cancer Center, AdventHealth, University of Central Florida
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Dec 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.
To evaluate the impact of an adapted online, self-help relationship intervention (supplemented with brief coach calls) for survivors of breast cancer and their partners. Couples will be randomized to receive either the online intervention (Together after Cancer) or usual care (UC) and assessed at baseline, end of the program, and 3 months after randomization.
Detailed description
As the fastest-growing and largest ethnic minority group, projections indicate that 128 million Latinos will reside in the United States by 2050; with one in three Latinos receiving a diagnosis of cancer during his/her lifetime. Latino cancer survivors have a lower quality of life, experience distress due to strained spousal and family relationships, have poorer physical health, and have more depression, pain, and fatigue when compared to non-Latinos. In addition, emotional and mental well-being between Latino survivors and their partners is related, with partners also experiencing increased distress and physical symptoms. Research has shown that couples-based psychosocial programs improve the quality of life and emotional and physical health of cancer survivors and their partners. Yet, much of the in this area has focused on non-Hispanic Whites. Features of Latino culture may influence and interact with social, psychosocial, health care, and clinical factors that influence cancer-related outcomes. Our goal is to add to this literature and develop a program for Latina breast cancer survivors and their partners that is culturally meaningful and relevant and responds to their needs and concerns.
Specifically, investigators plan to culturally adapt a widely-available and effective online couple intervention, OurRelationship (ORI), for Latina breast cancer survivors and their intimate partners. The online OR program - which can be done on a smartphone, tablet, or computer - was developed to serve as an online tool to help couples solve a specific relationship problem they selected. Investigators will adapt the OR program to be useful for Latina breast cancer survivors and their intimate partners using feedback from focus groups with patients, community partners, and research advisors. Once investigators have completed our adaptation, the plan to test the impact of the adapted program, Together after Cancer, using a type of study called a randomized controlled trial where participants will be randomly allocated to either receive the culturally adapted intervention or usual care. Investigators are interested in learning if couples in the group that are assigned to the intervention program report changes in their relationship functioning, psychological functioning (depression, anxiety, and perceived stress), and cancer-related quality of life (pain, fatigue, body image, and quality of life) compared to couples who are assigned to the UC group.
Through this comparative study, investigators expect to establish effective strategies that can be implemented in clinic and community settings to improve psychological functioning, relationship functioning, and quality of life. Investigators are enthusiastic about the potential for the intervention program to easily reach cancer Latina survivors around the nation, due to the online format and ease of access from any location. Throughout the project, investigators will continue to engage our local partners to ensure that the study procedures and outcomes are meaningful to all stakeholders.
Investigators are using patient-centered approaches to offer a culturally relevant web-based program that cancer survivors and their partners can access from the comfort of their homes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study aims to test the impact of the adapted Together After Cancer intervention using a cluster randomized controlled trial (cRCT), with individuals nested within couples and randomization occurring at the couple level to see if it is more effective than usual care (UC).
| Arm | Type | Receives |
|---|---|---|
| Together After Cancer Intervention | Experimental | Behavioral: Together After CancerCouples randomized into the intervention will participate in the program which is approximately 8-10 hours of web-based online content to be delivered over the course of 5-8 weeks. The online program can be done on a smartphone, tablet, or computer. In this program, partners complete the majority of the program on their own (to make it more flexible) and come together for 2-3 key conversations with their partner. In addition to the online content, couples will receive up to 100 minutes of scheduled research check-in/coaching calls from a research assistant to check-in. These coach calls will occur via a video chat via Zoom or, if not possible given a couple's technology limitations, over the phone. The coach calls serve several purposes: a) helping couples stay accountable to staying on the recommended schedule of activity completion; b) addressing any technical or program questions the couple has; and c) collecting research data as couples move through the program. |
| Usual Care | No intervention | –Participants randomized into UC, will consist of primary referral sources for breast cancer survivorship. At AdventHealth, Moffitt, and Sylvester Cancer centers, usual care consists of screening items assessing relationship/intimacy issues as a practical need. If these items are endorsed, referrals are provided to supportive oncology. At Sylvester, the Cancer Support Services offers caregiver support groups, "mental well-being" services (i.e., individual therapy), and an online support community for patients, caregivers, and survivors. At Moffitt, Support Services offers psychotherapy, support groups for patients, support groups for family/caregivers of cancer patients, and a program to help patients talk with their children about their diagnosis. At AdventHealth, patients are offered referrals to social services and psychoeducational programs like HEAL. However, none of the sites have services designed to focus on issues specific to patients' romantic relationships. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Be 18 years of age and older
- Self-identify as Latina/Hispanic
- Spanish or English speaker
- Primary diagnosis of breast cancer in the last ten years
- Completed initial treatment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Together After CancerThis is an online couples intervention for Latina breast cancer survivors and their intimate partners. | Behavioural | Together After Cancer Intervention |
Primary outcome
Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2 and 5 month
The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients which focuses on physical, social, emotional, functional well-being as well as a breast-cancer subscale. Each question is rated on a four-point scale from 0=Not at all to 4=Very Much. The scale has an internal consistency of an α=.90, with subscale alpha coefficients ranging from .63 to .86.
Evaluate the changes in the satisfaction of the relationship between couples who are married across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2 and 5 month
The Couples Satisfaction Index (CSI) is a 32- item instrument assess one's satisfaction in a relationship which assess the presence of problems between individuals and the intensity of such problems. Each question is rated on a six-point scale from 0=Extremely Unhappy to 6=Perfect. The scale as an internal consistency α=0.92.
10 secondary outcomes
Evaluate the changes in the cancer-related body image of the breast cancer survivor across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2 and 5 month
Evaluate the changes in cancer-related fatigue of the breast cancer across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2 and 5 month
Evaluate changes in the quality of life among the intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2 and 5 month
Evaluate changes in emotional distress-depression among breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in emotional distress-anxiety among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in stress among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in feeling cared and valued as a person among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in supportive communication among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in negative communication between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
Evaluate changes in intimacy between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
Time frame: Baseline, 2, 5 month
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 29 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together After Cancer in people with Breast Cancer and Quality of Life, run by University of South Florida at 3 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 16 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: under way, not looking for participants, as of the sponsor's last update on 29 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 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points. (time frame: Baseline, 2 and 5 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.