Gastrointestinal Neoplasm MalignantNCT06532877
Telephone Support in Advanced Gastrointestinal Cancer
A study testing Acceptance and Commitment Therapy and Education/Support in people with Gastrointestinal Neoplasm Malignant and Caregiver Burden, run by Indiana University at 4 sites in United States.
Trial summary
The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm Malignant, Caregiver Burden
- What is being tested?
- Acceptance and Commitment Therapy and Education/Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Aug 2024to Feb 2029
- 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
Patient Inclusion Criteria:
- Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., ampullary, anal, appendix, bile duct, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving cancer care at one of the study sites.
- Patient is at least 18 years of age.
- Patient can speak and read English.
- Patient has an eligible, consenting family caregiver (see criteria below).
- Patient has moderate to severe fatigue interference with functioning.
Patient Exclusion Criteria:
- Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
- Patient reports being able to do little activity on a functional status measure.
- Patient is receiving hospice care at screening.
- Patient does not have working phone service.
- Patient has hearing impairment that precludes participation.
- Patient participated in the pilot trial testing the same intervention.
Caregiver Inclusion Criteria:
- Family caregiver identified by a gastrointestinal cancer patient who meets the eligibility criteria.
- Caregiver has significant caregiving burden.
- Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month.
- Caregiver is at least 18 years of age.
- Caregiver can speak and read English.
Caregiver Exclusion Criteria:
- Caregiver shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
- Caregiver does not have working phone service.
- Caregiver has hearing impairment that precludes participation.
- Patient declines study participation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Elizabeth Addington, Ph.D.
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Eileen Shinn, Ph.D.
- Recruiting
Eskenazi Health
Indianapolis, Indiana, 46202
Hannah Mullin, 317-278-4005, cancerq@iu.edu
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46202
Hannah Mullin, 317-278-4005, cancerq@iu.edu
About this study
Official title: Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
The goal of this clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are:
Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support?
Read more
Participants in both study conditions will:
Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months
Read the detailed description
This trial tests the effects of telephone-delivered acceptance and commitment therapy (ACT) on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal (GI) cancer (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effects on patient fatigue interference and caregiver burden (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effects on patient fatigue interference and caregiver burden (Aim 4). The investigators will recruit advanced GI cancer patients and caregivers from Indiana University Health, Eskenazi Health, MD Anderson Cancer Center, and Northwestern University hospitals. Potentially eligible patients will be mailed a study introductory letter along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The research assistant will describe the study as outlined in the consent form and answer any questions. Then the research assistant will administer an eligibility screening to those who consent to participate. With the patient's permission, the primary family caregiver will also be mailed a consent form and contacted via phone to screen for eligibility and obtain consent. Consenting patients and caregivers will complete a 35-minute individual phone assessment at baseline.
Following baseline assessments, patient-caregiver dyads (N = 244) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient age (<65 vs. >=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline. Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention. Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up. During the booster session, ACT therapists will reinforce and address any barriers to skill practice, and education/support therapists will review key medical center and community resources.
- Being tested
- Acceptance and Commitment Therapy, Education/Support
- Keywords
- Gastrointestinal Neoplasms, Family Caregivers, Acceptance and Commitment Therapy, Fatigue, Psychotherapy, Caregiver Burden
- Medical subject headings
- Gastrointestinal Neoplasms, Caregiver Burden, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Patients and caregivers in the acceptance and commitment therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Education/SupportBehavioural
Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices. Receives: Behavioral: Acceptance and Commitment Therapy |
| Education/Support | Active comparator | Across six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. Receives: Behavioral: Education/Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Interference Subscale of Fatigue Symptom Inventory
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Measured: 2 weeks and 3 months post-intervention
Short-form of Zarit Burden Interview
Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
Measured: 2 weeks and 3 months post-intervention
Secondary outcomes (3)
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.
Measured: 2 weeks and 3 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities
This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.
Measured: 2 weeks and 3 months post-intervention
PROMIS Global Health measure
This 10-item measure assesses participants' physical, mental, and social well-being. Items are rated on scales from 5 (excellent) to 1 (poor) and 5 (completely) to 1 (not at all). One item is rated on a scale from 5 (never) to 1 (always), and another item is rated on a scale from 5 (none) to 1 (very severe). Pain is rated on a scale from 0 (no pain) to 10 (worst pain imaginable) and recoded so that higher numbers indicate less pain. The items are then summed into Global Physical Health and Global Mental Health scores. The total scores are converted to T-scores with a range from 16.2 to 67.7 (Global Physical Health) and 21.2 to 67.6 (Global Mental Health), with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients and caregivers.
Measured: 2 weeks and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start21 Aug 2024
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (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 Gastrointestinal Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Advanced gastrointestinal cancer patient-family caregiver dyads (N = 244) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient age (\<65 vs. \>=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northwestern University, M.D. Anderson Cancer Center, Eskenazi Health
- Responsible party
- Principal investigator, Catherine Mosher, Indiana University
- Investigators
- Catherine E Mosher, Ph.D., Principal investigator, Indiana University Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532877
- Sponsor's protocol ID
- 21611
- Other IDs
- R01CA289486
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset to be shared will include individual-level baseline, procedural-based (intervention session attendance, homework completion), and outcome data for approximately 244 patients and 244 family caregivers. Data will be collected from self-report surveys and the Electronic Medical Record (EMR). Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. To protect the privacy of study participants, the investigators will develop a plan for de-identification of this dataset, which will address participant identifiers, dates, variables that are administrative or sensitive in nature, unedited verbatim responses that are stored as text data, and variables with low frequencies for some values.
Publications
Mosher CE, Shinn EH, Addington EL, Wu W, Bricker JB, Helft PR, Turk AA, Vater LB, Masood A, Jalal SI, Loehrer PJ Sr, Champion VL, Johns SA. Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer. Contemp Clin Trials. 2026 Jan;160:108168. doi: 10.1016/j.cct.2025.108168. Epub 2025 Nov 26.
PubMed 41314597
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Support Program for Patients With Advanced Gastrointestinal Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT06532877
- Acronym / sponsor ID
- 21611
- Keywords
- Gastrointestinal Neoplasms, Family Caregivers, Acceptance and Commitment Therapy, Fatigue, Psychotherapy, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Northwestern University, M.D. Anderson Cancer Center, Eskenazi Health
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 1 Aug 2024 (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 clinical trial is to see if telephone support programs help patients and their family caregivers adjust to advanced gastrointestinal cancer. A new telephone counseling program that involves practicing strategies for managing stress and symptoms will be compared to a telephone program involving education on quality-of-life issues and psychosocial support. The main questions it aims to answer are:
Does our telephone counseling program lower the negative impact of patients' fatigue on their activities, emotions, and thinking abilities compared to a telephone program involving education and support? Does our telephone counseling program lower family caregivers' feelings of burden compared to a telephone program involving education and support?
Participants in both study conditions will:
Complete 6 weekly telephone sessions of counseling or education/support Complete a telephone booster session Complete 3 telephone interviews over about 5 months
Detailed description
This trial tests the effects of telephone-delivered acceptance and commitment therapy (ACT) on patient fatigue interference with functioning and family caregiver burden in advanced gastrointestinal (GI) cancer (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effects on patient fatigue interference and caregiver burden (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effects on patient fatigue interference and caregiver burden (Aim 4). The investigators will recruit advanced GI cancer patients and caregivers from Indiana University Health, Eskenazi Health, MD Anderson Cancer Center, and Northwestern University hospitals. Potentially eligible patients will be mailed a study introductory letter along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The research assistant will describe the study as outlined in the consent form and answer any questions. Then the research assistant will administer an eligibility screening to those who consent to participate. With the patient's permission, the primary family caregiver will also be mailed a consent form and contacted via phone to screen for eligibility and obtain consent. Consenting patients and caregivers will complete a 35-minute individual phone assessment at baseline.
Following baseline assessments, patient-caregiver dyads (N = 244) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient age (<65 vs. >=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in both groups will complete six weekly 50-minute telephone sessions with the first session occurring one week after baseline. Blind interviewers will assess outcomes during 30-minute individual phone assessments at 2 weeks and 3 months post-intervention. Dyads in both conditions will also complete a 30-minute booster phone session one month after the 2-week follow-up. During the booster session, ACT therapists will reinforce and address any barriers to skill practice, and education/support therapists will review key medical center and community resources.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Advanced gastrointestinal cancer patient-family caregiver dyads (N = 244) will be randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient age (<65 vs. >=65 years) and performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2).
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyAcross six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that the team developed to guide mindfulness practices. |
| Education/Support | Active comparator | Behavioral: Education/SupportAcross six weekly 50-minute sessions and a booster session, advanced gastrointestinal cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Acceptance and Commitment TherapyPatients and caregivers in the acceptance and commitment therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). | Behavioural | Acceptance and Commitment Therapy |
| Education/SupportPatients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. | Behavioural | Education/Support |
Primary outcome
Fatigue Interference Subscale of Fatigue Symptom Inventory
Time frame: 2 weeks and 3 months post-intervention
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Short-form of Zarit Burden Interview
Time frame: 2 weeks and 3 months post-intervention
Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
3 secondary outcomes
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
Time frame: 2 weeks and 3 months post-intervention
PROMIS Ability to Participate in Social Roles and Activities
Time frame: 2 weeks and 3 months post-intervention
PROMIS Global Health measure
Time frame: 2 weeks and 3 months post-intervention
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 6 Jul 2026.
- Derived from this study: PubMed 41314597Mosher CE, Shinn EH, Addington EL, Wu W, Bricker JB, Helft PR, Turk AA, Vater LB, Masood A, Jalal SI, Loehrer PJ Sr, Champion VL, Johns SA. Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer. Contemp Clin Trials. 2026 Jan;160:108168. doi: 10.1016/j.cct.2025.108168. Epub 2025 Nov 26.
- Individual participant dataSharing planned: Yes. The dataset to be shared will include individual-level baseline, procedural-based (intervention session attendance, homework completion), and outcome data for approximately 244 patients and 244 family caregivers. Data will be collected from self-report surveys and the Electronic Medical Record (EMR). Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. To protect the privacy of study participants, the investigators will develop a plan for de-identification of this dataset, which will address participant identifiers, dates, variables that are administrative or sensitive in nature, unedited verbatim responses that are stored as text data, and variables with low frequencies for some values.
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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.
Catherine E Mosher, Ph.D. principal investigator
Indiana University Indianapolis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy and Education/Support in people with Gastrointestinal Neoplasm Malignant and Caregiver Burden, run by Indiana University at 4 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?
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 6 Jul 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 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?
Contact Hannah Mullin (317-278-4005, cancerq@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Interference Subscale of Fatigue Symptom Inventory (time frame: 2 weeks and 3 months post-intervention). 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?
On the ClinicalTrials.gov record for NCT06532877, 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 6 Jul 2026.