Family CaregiversBeSSINCT04661306
The Better Sleep for Supporters With Insomnia Study
A study testing SHUTi (Sleep Healthy Using the Internet) in people with Family Caregivers and Cancer, run by University of Virginia at 1 site in United States.
Trial summary
This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family Caregivers, Cancer, Insomnia
- What is being tested?
- SHUTi (Sleep Healthy Using the Internet)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-report providing unpaid care (e.g., practical, medical, and/or emotional support) to an adult family member or "family-like" close individual who is either currently undergoing any anti-cancer treatment (e.g., surgery, chemotherapy, radiation, for either curative or palliative intent) or has completed anti-cancer treatment within the past 2 years.
- Insomnia severity index score of 10 or higher
- age 18 and over
- regular access (at least 2/week) and willingness to use a computer and the Internet and check email
- ability to read and speak English
- resident of the US
Who cannot join
- irregular sleep schedules that prevent the ability to follow intervention recommendations (i.e., with usual bedtimes outside of 8:00pm to 2:00am or arising time outside of 4:00am to 10:00am)
- current psychological treatment for insomnia
- screen positive for a history of psychotic or bipolar disorder; and current severe depression, high risk of suicide, substance use (alcohol, drug) disorder within the past year
- symptoms suggestive of untreated sleep disorders other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder)
- presence of uncontrolled medical condition that is deemed to interfere with the study procedures, or put the study participant at undue risk
- Unstable medication regimen (change to schedule or dosage within past 3 months) for a prescription medication regimen thought to impact sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers
This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.
Read the detailed description
Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, and/or emotional support for a loved one with cancer endorse clinically significant sleep disturbance. Understanding caregivers' psychosocial risk factors and needs, and the extent to which these are unique to the cancer caregiving context, will ensure appropriate and effective interventions for cancer caregivers with insomnia.
Existing psychosocial services for caregivers are primarily delivered in-person. Although such interventions are effective, they suffer from low enrollment, high dropout, and limited reach to caregivers who already have inadequate healthcare access, like caregivers from lower SES or those in rural areas. Digital health interventions can lower barriers to entry to supportive care for caregivers as they are conveniently accessible anywhere and anytime from an Internet-enabled device. Sleep Healthy Using the Internet (SHUTi) is a NCI-designated research-tested intervention that delivers cognitive-behavioral therapy for insomnia (CBT-I) and holds significant potential to accessibly treat insomnia for cancer caregivers. Most digital health interventions tested among caregivers, however, have been developed de novo for specific caregiving contexts. The implicit assumption underlying highly tailored interventions for caregivers is that caregivers have different deficits, risk factors, and needs from non-caregivers. This assumption has not often been tested, and therefore the extent to which caregivers want and need tailoring for digital health interventions is not known. This study is therefore designed to provide the data necessary to ensure the highest quality, impact, and efficiency from existing evidence-based digital health interventions to meet pressing psychosocial needs among cancer caregivers. Specifically, this study will directly inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers.
The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence. There is no content that is specifically about cancer or caregiving.
Caregivers participating in this study will complete a baseline assessment (questionnaires and 2 weeks of daily sleep diaries), and then will receive complementary and voluntary access to SHUTi. Participants who choose to complete 1 or more SHUTi Cores will complete a follow-up assessment of questionnaires and 2 weeks of sleep diaries; participants who choose not to complete any SHUTi cores will be asked to provide brief feedback regarding their reasons/barriers.
- Being tested
- SHUTi (Sleep Healthy Using the Internet)
- Keywords
- Family Caregivers, Cancer, Insomnia
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTi (Sleep Healthy Using the Internet)Behavioural
Also called CBTi
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
| Study group | Role | What they receive |
|---|---|---|
| SHUTi | Experimental | Not described Receives: Behavioral: SHUTi (Sleep Healthy Using the Internet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SHUTi Usage
Number of SHUTi Cores completed by participants
Measured: 9 weeks
Secondary outcomes (22)
Insomnia severity
Insomnia severity index; 7 items; summed scores range from 0 to 28 (higher scores indicate more severe insomnia symptoms)
Measured: Baseline, 9 weeks
Sleep onset latency (SOL)
Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep
Measured: Baseline, 9 weeks
Wake after sleep onset (WASO)
Data collected from sleep diary: Total time awake between time feel asleep and final morning waking
Measured: Baseline, 9 weeks
Perceived sleep quality
Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good
Measured: Baseline, 9 weeks
Sleep-related cognitions
Dysfunctional Beliefs and Attitudes about Sleep; 16 items; averaged scores range from 0 to 10 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)
Measured: Baseline, 9 weeks
Sleep self-efficacy
Sleep Self-Efficacy Scale; 13-items; averaged scores range from 0 to 10 (higher scores indicate greater self-efficacy)
Measured: Baseline, 9 weeks
Internal and chance sleep locus of control
Sleep Locus of Control Scale; 4-item subscales for internal and chance locus of control, respectively; averaged scores per scale range from 1 to 6 (higher scores indicate higher belief in the locus of control measured)
Measured: Baseline, 9 weeks
Caregiving burden
Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)
Measured: Baseline, 9 weeks
Caregiving competence
Pearlin Stress Scale - Caregiving Competence subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived competence)
Measured: Baseline, 9 weeks
Physical Function
PROMIS SF v2.0 - Physical Function 8b; 8 items; scored on a normalized T-score distribution (higher scores indicate higher physical function)
Measured: Baseline, 9 weeks
Anxiety
PROMIS SF v2.0 - Anxiety 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher anxiety)
Measured: Baseline, 9 weeks
Depression
PROMIS SF v2.0 - Depression 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher depression)
Measured: Baseline, 9 weeks
Fatigue
PROMIS SF v2.0 - Fatigue 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher fatigue)
Measured: Baseline, 9 weeks
Sleep Disturbance
PROMIS SF v2.0 - Sleep Disturbance 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher sleep disturbance)
Measured: Baseline, 9 weeks
Social functioning
PROMIS SF v2.0 - Ability to Participant in Social Roles and Activities 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher social function)
Measured: Baseline, 9 weeks
Pain Interference
PROMIS SF v2.0 - Pain Interference 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher pain interference)
Measured: Baseline, 9 weeks
Pain Intensity
PROMIS SF v2.0 - Pain Intensity item; 1 item (higher score indicate higher pain intensity)
Measured: Baseline, 9 weeks
Experiences with Internet intervention
Internet Intervention Utility Questionnaire (UQ) for SHUTi; 18 items; items examined individually
Measured: 9 weeks
Perceptions of Internet intervention
Internet Intervention Impact and Effectiveness Questionnaire (IEQ) for SHUTi; 29 items; items examined individually
Measured: 9 weeks
Adherence to Internet intervention
Internet Intervention Adherence Questionnaire (AQ) for SHUTi; 20 items; items examined individually
Measured: 9 weeks
SHUTi Feasibility as assessed by open-ended feedback
Open-ended survey items regarding barriers to using SHUTi
Measured: 9 weeks
SHUTi Acceptability as assessed by open-ended feedback
Open-ended survey items regarding appropriateness of SHUTi to address caregivers' sleep needs
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start30 Sep 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family CaregiversStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Shaffer, PhD, University of Virginia
- Investigators
- Kelly Shaffer, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661306
- Sponsor's protocol ID
- 3809
- Acronym
- BeSSI
- Status last verified
- May 2022
- First submitted
- 28 Oct 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
PubMed 27902836Shaffer KM, Garland SN, Mao JJ, Applebaum AJ. Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. J Psychother Integr. 2018 Sep;28(3):275-291. doi: 10.1037/int0000105.
PubMed 30245560
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers
- ClinicalTrials.gov ID
- NCT04661306
- Acronym / sponsor ID
- BeSSI / 3809
- Keywords
- Family Caregivers, Cancer, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Dec 2020 (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.
This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.
Detailed description
Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, and/or emotional support for a loved one with cancer endorse clinically significant sleep disturbance. Understanding caregivers' psychosocial risk factors and needs, and the extent to which these are unique to the cancer caregiving context, will ensure appropriate and effective interventions for cancer caregivers with insomnia.
Existing psychosocial services for caregivers are primarily delivered in-person. Although such interventions are effective, they suffer from low enrollment, high dropout, and limited reach to caregivers who already have inadequate healthcare access, like caregivers from lower SES or those in rural areas. Digital health interventions can lower barriers to entry to supportive care for caregivers as they are conveniently accessible anywhere and anytime from an Internet-enabled device. Sleep Healthy Using the Internet (SHUTi) is a NCI-designated research-tested intervention that delivers cognitive-behavioral therapy for insomnia (CBT-I) and holds significant potential to accessibly treat insomnia for cancer caregivers. Most digital health interventions tested among caregivers, however, have been developed de novo for specific caregiving contexts. The implicit assumption underlying highly tailored interventions for caregivers is that caregivers have different deficits, risk factors, and needs from non-caregivers. This assumption has not often been tested, and therefore the extent to which caregivers want and need tailoring for digital health interventions is not known. This study is therefore designed to provide the data necessary to ensure the highest quality, impact, and efficiency from existing evidence-based digital health interventions to meet pressing psychosocial needs among cancer caregivers. Specifically, this study will directly inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers.
The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence. There is no content that is specifically about cancer or caregiving.
Caregivers participating in this study will complete a baseline assessment (questionnaires and 2 weeks of daily sleep diaries), and then will receive complementary and voluntary access to SHUTi. Participants who choose to complete 1 or more SHUTi Cores will complete a follow-up assessment of questionnaires and 2 weeks of sleep diaries; participants who choose not to complete any SHUTi cores will be asked to provide brief feedback regarding their reasons/barriers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHUTi | Experimental | Behavioral: SHUTi (Sleep Healthy Using the Internet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-report providing unpaid care (e.g., practical, medical, and/or emotional support) to an adult family member or "family-like" close individual who is either currently undergoing any anti-cancer treatment (e.g., surgery, chemotherapy, radiation, for either curative or palliative intent) or has completed anti-cancer treatment within the past 2 years.
- Insomnia severity index score of 10 or higher
- age 18 and over
- regular access (at least 2/week) and willingness to use a computer and the Internet and check email
- ability to read and speak English
Key exclusion criteria (6 listed)
- irregular sleep schedules that prevent the ability to follow intervention recommendations (i.e., with usual bedtimes outside of 8:00pm to 2:00am or arising time outside of 4:00am to 10:00am)
- current psychological treatment for insomnia
- screen positive for a history of psychotic or bipolar disorder; and current severe depression, high risk of suicide, substance use (alcohol, drug) disorder within the past year
- symptoms suggestive of untreated sleep disorders other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder)
- presence of uncontrolled medical condition that is deemed to interfere with the study procedures, or put the study participant at undue risk
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 |
|---|---|---|
| SHUTi (Sleep Healthy Using the Internet)Also: CBTiCognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program | Behavioural | SHUTi |
Primary outcome
SHUTi Usage
Time frame: 9 weeks
Number of SHUTi Cores completed by participants
22 secondary outcomes
Insomnia severity
Time frame: Baseline, 9 weeks
Sleep onset latency (SOL)
Time frame: Baseline, 9 weeks
Wake after sleep onset (WASO)
Time frame: Baseline, 9 weeks
Perceived sleep quality
Time frame: Baseline, 9 weeks
Sleep-related cognitions
Time frame: Baseline, 9 weeks
Sleep self-efficacy
Time frame: Baseline, 9 weeks
Internal and chance sleep locus of control
Time frame: Baseline, 9 weeks
Caregiving burden
Time frame: Baseline, 9 weeks
Caregiving competence
Time frame: Baseline, 9 weeks
Physical Function
Time frame: Baseline, 9 weeks
Anxiety
Time frame: Baseline, 9 weeks
Depression
Time frame: Baseline, 9 weeks
Fatigue
Time frame: Baseline, 9 weeks
Sleep Disturbance
Time frame: Baseline, 9 weeks
Social functioning
Time frame: Baseline, 9 weeks
Pain Interference
Time frame: Baseline, 9 weeks
Pain Intensity
Time frame: Baseline, 9 weeks
Experiences with Internet intervention
Time frame: 9 weeks
Perceptions of Internet intervention
Time frame: 9 weeks
Adherence to Internet intervention
Time frame: 9 weeks
SHUTi Feasibility as assessed by open-ended feedback
Time frame: 9 weeks
SHUTi Acceptability as assessed by open-ended feedback
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 27902836Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
- Background: PubMed 30245560Shaffer KM, Garland SN, Mao JJ, Applebaum AJ. Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. J Psychother Integr. 2018 Sep;28(3):275-291. doi: 10.1037/int0000105.
- Center for Behavioral Health and Technology websiteLink provided by the sponsor.
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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.
Kelly Shaffer, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi (Sleep Healthy Using the Internet) in people with Family Caregivers and Cancer, run by University of Virginia 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 6 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 17 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SHUTi Usage (time frame: 9 weeks). 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 NCT04661306, 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 17 May 2022.