CaregiverNCT03032250
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
A study testing Communication Intervention, Watch video and Module completion of the Prepare to Care kit in people with Caregiver and Malignant Head and Neck Neoplasm, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma
- What is being tested?
- Communication Intervention, Watch video and Module completion of the Prepare to Care kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 10 Apr 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CAREGIVERS:
- Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study
- CARE-RECIPIENTS:
- Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)
- Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks
- Has an informal (unpaid) caregiver during radiation therapy who is participating in study
Who cannot join
- CAREGIVERS: Has a current cancer diagnosis
- CAREGIVERS: Cannot read/communicate in English
- CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study
- CARE-RECIPIENTS: Cannot read/communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).
II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).
III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.
IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.
- Conditions
- Caregiver, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage I Hypopharyngeal Squamous Cell Carcinoma, Stage I Laryngeal Squamous Cell Carcinoma
- Being tested
- Communication Intervention, Watch video, Module completion of the Prepare to Care kit, Quality-of-Life Assessment, Survey Administration
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Attend interventionist sessions
Watch videoOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Watch video on a DVD
Module completion of the Prepare to Care kitOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Complete modules of the Prepare to Care kit
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Survey AdministrationOther
Ancillary studies
Salivary cortisol collectionOther
Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
| Study group | Role | What they receive |
|---|---|---|
| Group I Supportive Care (Prepare to Care kit) | Experimental | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Receives: Other: Communication Intervention; Other: Watch video; Other: Module completion of the Prepare to Care kit; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Salivary cortisol collection |
| Group II Control Group | Experimental | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study Receives: Other: Watch video; Other: Module completion of the Prepare to Care kit; Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Salivary cortisol collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
Measured: Six weeks post radiation therapy
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
Measured: Up to 1 year
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
Measured: Baseline and following radiotherapy, assessed up to 1 year
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
Measured: Before and after radiotherapy, assessed up to 1 year
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
Measured: Before and after radiotherapy, assessed up to 1 year
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Data on intervention resources used and time spent using them based on caregivers in intervention group
Measured: Up to 1 year
Number of Participants in Agreement to Perform Interventions
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Measured: Up to 1 year
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
Measured: Up to 1 year
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
Measured: At baseline and up to the end of radiotherapy, assessed up to 1 year
Self-efficacy in Coping With Cancer Caregiver Inventory
21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
Measured: At baseline and up to the end of radiotherapy, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start15 May 2017
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chandylen Nightingale, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032250
- Sponsor's protocol ID
- IRB00038084
- Other IDs
- NCI-2016-02045, CCCWFU 99616, P30CA012197, R03CA208560
- Status last verified
- Dec 2022
- First submitted
- 17 Jan 2017
- Last updated
- 9 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984.
PubMed 35575280
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
- ClinicalTrials.gov ID
- NCT03032250
- Acronym / sponsor ID
- IRB00038084
- Conditions
- Caregiver, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage I Hypopharyngeal Squamous Cell Carcinoma, Stage I Laryngeal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 1 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.
Detailed description
PRIMARY OBJECTIVES:
- To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).
II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).
III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.
IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.
GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I Supportive Care (Prepare to Care kit) | Experimental | Other: Communication Intervention, Other: Watch video, Other: Module completion of the Prepare to Care kit, Other: Quality-of-Life Assessment, Other: Survey Administration, Other: Salivary cortisol collectionCaregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. |
| Group II Control Group | Experimental | Other: Watch video, Other: Module completion of the Prepare to Care kit, Other: Quality-of-Life Assessment, Other: Survey Administration, Other: Salivary cortisol collectionCaregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study
- Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)
- Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks
- Has an informal (unpaid) caregiver during radiation therapy who is participating in study
Key exclusion criteria (4 listed)
- CAREGIVERS: Has a current cancer diagnosis
- CAREGIVERS: Cannot read/communicate in English
- CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study
- CARE-RECIPIENTS: Cannot read/communicate in English
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 |
|---|---|---|
| Communication InterventionAttend interventionist sessions | Other | Group I Supportive Care (Prepare to Care kit) |
| Watch videoAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalWatch video on a DVD | Other | Group I Supportive Care (Prepare to Care kit), Group II Control Group |
| Module completion of the Prepare to Care kitAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalComplete modules of the Prepare to Care kit | Other | Group I Supportive Care (Prepare to Care kit), Group II Control Group |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I Supportive Care (Prepare to Care kit), Group II Control Group |
| Survey AdministrationAncillary studies | Other | Group I Supportive Care (Prepare to Care kit), Group II Control Group |
| Salivary cortisol collectionObtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. | Other | Group I Supportive Care (Prepare to Care kit), Group II Control Group |
Primary outcome
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
Time frame: Six weeks post radiation therapy
10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
Time frame: Up to 1 year
38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
Time frame: Baseline and following radiotherapy, assessed up to 1 year
21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
Time frame: Before and after radiotherapy, assessed up to 1 year
The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
Time frame: Before and after radiotherapy, assessed up to 1 year
35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Time frame: Up to 1 year
Data on intervention resources used and time spent using them based on caregivers in intervention group
Number of Participants in Agreement to Perform Interventions
Time frame: Up to 1 year
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
Time frame: Up to 1 year
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
Self-efficacy in Coping With Cancer Caregiver Inventory
Time frame: At baseline and up to the end of radiotherapy, assessed up to 1 year
21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35575280Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984.
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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.
Chandylen Nightingale principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Watch video and Module completion of the Prepare to Care kit in people with Caregiver and Malignant Head and Neck Neoplasm, run by Wake Forest University Health Sciences at 1 site 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 6 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 1 Jul 2021). 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?
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions (time frame: Six weeks post radiation therapy). The study lists 10 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 NCT03032250, 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 9 Jan 2023.