Pediatric CancerFOCUSNCT04075877
FOCUS for Pediatric Sickle Cell Disease and Cancer
A study testing FOCUS in people with Pediatric Cancer and Sickle Cell Disease, run by Georgia State University at 2 sites in United States.
Trial summary
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pediatric Cancer, Sickle Cell Disease, Quality of Life
- What is being tested?
- FOCUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jan 2020to 30 Jul 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) diagnosis of sickle cell disease, any hemoglobin type or diagnosis of leukemia, lymphoma, or solid tumor
- 2) inpatient at CHOA
- 3) 12-18 years of age
- 4) English speaking
- 5) owns a smartphone with camera.
Who cannot join
- 1) report of active psychosis or active suicidal ideation in the adolescents
- 2) significant documented developmental delay, autism spectrum disorder, or significant intellectual impairment, as these comorbidities may confound the study aims by impacting the dependent measures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Georgia State University
Atlanta, Georgia, 30302
Lindsey L Cohen, PhD, 404-413-6263, llcohen@gsu.edu
Chris Henrich, PhD, 4044136203, chenrich@gsu.edu
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
Lindsey L Cohen, PhD
Laura G McKee, PhD
About this study
Official title: FOCUS: Feasibility, Acceptability, and Pilot of an Intervention to Improve Functioning in Adolescents With Sickle Cell Disease and Cancer
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.
Read the detailed description
Sickle cell disease (SCD) and cancer are medical conditions in youth that are associated with psychosocial problems including anxiety and depressive symptoms and impaired health-related quality of life. Both SCD and cancer can require a number of treatments and hospitalizations, which negatively impact family relationships, peer functioning, and other life domains. In addition, both conditions and treatments can involve a range of symptoms or side effects (e.g., pain, fatigue, nausea) that interfere with daily life. In other words, patients with SCD and cancer are responsible for gradually learning to manage and live with challenges associated with their medical condition. As such, recent efforts focus on providing psychological interventions to support self-management as an adjunct to standard medical care.
Children and adolescents with SCD and cancer may have limited access to skilled psychologists or may not be able to attend frequent in-person intervention visits to acquire skills to support psychosocial functioning. A critical barrier to helping adolescents with SCD and cancer is that there are few portable interventions that provide assistance outside of the hospital environment.
The goal of this proposal is to pilot test FOCUS (Framing Opportunities and Challenges Using Stories), an innovative and portable intervention designed to improve the psychosocial functioning of adolescents with medical conditions. The intervention involves taking and captioning purposeful photographs that align with The Hero's Journey, a guiding narrative template that chronicles a hero's passage through life's adventures and challenges, culminating in individual strength and transformation (Campbell, 1968). Preliminary data evaluating components of FOCUS revealed significant improvements in mood among healthy adolescents and young adults. Data suggest that reflecting on positive and negative daily events (e.g., via a photograph) and writing about the experiences have profound positive effects on a range of outcomes (e.g., grit, gratitude, functioning). In addition, the investigators intend to share the participants' photographs, stories, and advice on a website for other adolescents with SCD or cancer. Data indicate that prosocial behavior (e.g., providing advice to peers) and social connectedness have a number of positive outcomes. The central prediction is that FOCUS will be acceptable and feasible to deliver and that pilot data will reveal improvements in participants' psychosocial health. Achieving these aims will provide the foundational data needed for federal grant applications to evaluate FOCUS with a larger pediatric sample and other patient populations, powered to identify outcomes and mechanisms of change.
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.
- Conditions
- Pediatric Cancer, Sickle Cell Disease, Quality of Life, Depressive Symptoms, Coping Skills
- Being tested
- FOCUS
- Keywords
- Pediatric cancer, Pediatric Sickle Cell Disease, Quality of Life, Randomized Controlled Trial, Intervention, Photography, Narrative Psychology, Adolescence
- Medical subject headings
- Neoplasms, Anemia, Sickle Cell, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCUSBehavioural
See prior section.
| Study group | Role | What they receive |
|---|---|---|
| FOCUS | Experimental | Participants will complete a baseline survey battery and learn about The Hero's Journey. Starting at hospital discharge for 10 days, they will do the following: 1) identify which stage of The Hero's Journey they are experiencing; 2) take a picture of something good and write a caption describing the picture and provide advice; and 3) take a picture of something difficult or challenging during the day and write a caption for the photo and provide advice.
Daily text messages will remind participants to take the photographs, write the advice captions, upload both to the server, as well as to take a very brief daily survey. At the conclusion of day 10, participants will be asked to review their photos and captions and provide final advice in the form of a letter to other adolescents with SCD or cancer. Finally, they will complete a post-intervention battery. Receives: Behavioral: FOCUS |
| Control | No intervention | In a 30-min visit (in person or virtual) with adolescents during hospitalizations, we will have participants complete a baseline survey battery. Daily text messages will remind participants to take a very brief daily survey. At the conclusion of day 10, participants will complete a post-intervention battery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Satisfaction
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 8a; Forrest, C. B., Devine, J., Bevans, K. B., Becker, B. D., Carle, A. C., Teneralli, R. E., … Ravens-Sieberer, U. (2018). Development and psychometric evaluation of the PROMIS Pediatric Life Satisfaction item banks, child-report, and parent-proxy editions. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 27(1), 217-234. doi:10.1007/s11136-017-1681-7; Scores range from 8-40, with higher scores representing more life satisfaction
Measured: Change from baseline to post-intervention at 10 days
Depression
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Depressive Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more depression
Measured: Change from baseline to post-intervention at 10 days
Anxiety
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Anxiety Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more anxiety
Measured: Change from baseline to post-intervention at 10 days
Meaning and Purpose
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Meaning and Purpose - Short Form 8a; Christopher B Forrest, Katherine B Bevans, Ania Filus, Janine Devine, Brandon D Becker, Adam C Carle, Rachel E Teneralli, JeanHee Moon, Ulrike Ravens-Sieberer, Assessing Children's Eudaimonic Well-Being: The PROMIS Pediatric Meaning and Purpose Item Banks, Journal of Pediatric Psychology, jsz046, https://doi.org/10.1093/jpepsy/jsz046; Scores range from 8-40, with higher scores representing more meaning and purpose
Measured: Change from baseline to post-intervention at 10 days
Positive Affect
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Positive Affect - Short Form 8a; Forrest, C. B., Ravens-Sieberer, U., Devine, J., Becker, B. D., Teneralli, R., Moon, J., … Bevans, K. B. (2018). Development and Evaluation of the PROMIS® Pediatric Positive Affect Item Bank, Child-Report and Parent-Proxy Editions. Journal of happiness studies, 19(3), 699-718. doi:10.1007/s10902-016-9843-9; Scores range from 8-40, with higher scores representing more positive affect
Measured: Change from baseline to post-intervention at 10 days
Functional Disability
Functional Disability Inventory (FDI)
Measured: Change from baseline to post-intervention at 10 days
Mindfulness
Child and Adolescence Mindfulness Measure (CAMM)
Measured: Change from baseline to post-intervention at 10 days
Approach to Dealing with Adversity
Shift and Persist Measure
Measured: Change from baseline to post-intervention at 10 days
Secondary outcomes (2)
Resilience
Conner-Davidson Resilience Scale - 10; Davidson, J. R. T. \& Connor, K. M. Connor-Davidson Resilience Scale (CD-RISC) Manual. Unpublished. 06-01-2018 and partly accessible at www.cd-risc.com.Total Score Range 0-40, with higher scores reflecting higher resilience
Measured: Change from baseline to post-intervention at 10 days
Social Connectedness
Social Connectedness and Social Assurance Scale; Lee, R. M., \& Robbins, S. B. (1995). Measuring belongingness: The social connectedness and the social assurance scales. Journal of Counseling Psychology, 42, 232-241; Using the Social Connectedness Factor only; 8 items; Range 8-48, with higher scores reflecting higher levels of social connectedness and belongingness
Measured: Change from baseline to post-intervention at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start10 Jan 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mckee, Georgia State University
- Investigators
- Lindsey L Cohen, PhD, Principal investigator, Georgia State UniversityLaura G McKee, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075877
- Sponsor's protocol ID
- FOCUS
- Acronym
- FOCUS
- Status last verified
- Jan 2020
- First submitted
- 9 Jul 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOCUS: Feasibility, Acceptability, and Pilot of an Intervention to Improve Functioning in Adolescents With Sickle Cell Disease and Cancer
- ClinicalTrials.gov ID
- NCT04075877
- Acronym / sponsor ID
- FOCUS / FOCUS
- Conditions
- Pediatric Cancer, Sickle Cell Disease, Quality of Life, Depressive Symptoms, Coping Skills
- Keywords
- Pediatric cancer, Pediatric Sickle Cell Disease, Quality of Life, Randomized Controlled Trial, Intervention, Photography, Narrative Psychology, Adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 3 Sep 2019 (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.
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.
Detailed description
Sickle cell disease (SCD) and cancer are medical conditions in youth that are associated with psychosocial problems including anxiety and depressive symptoms and impaired health-related quality of life. Both SCD and cancer can require a number of treatments and hospitalizations, which negatively impact family relationships, peer functioning, and other life domains. In addition, both conditions and treatments can involve a range of symptoms or side effects (e.g., pain, fatigue, nausea) that interfere with daily life. In other words, patients with SCD and cancer are responsible for gradually learning to manage and live with challenges associated with their medical condition. As such, recent efforts focus on providing psychological interventions to support self-management as an adjunct to standard medical care.
Children and adolescents with SCD and cancer may have limited access to skilled psychologists or may not be able to attend frequent in-person intervention visits to acquire skills to support psychosocial functioning. A critical barrier to helping adolescents with SCD and cancer is that there are few portable interventions that provide assistance outside of the hospital environment.
The goal of this proposal is to pilot test FOCUS (Framing Opportunities and Challenges Using Stories), an innovative and portable intervention designed to improve the psychosocial functioning of adolescents with medical conditions. The intervention involves taking and captioning purposeful photographs that align with The Hero's Journey, a guiding narrative template that chronicles a hero's passage through life's adventures and challenges, culminating in individual strength and transformation (Campbell, 1968). Preliminary data evaluating components of FOCUS revealed significant improvements in mood among healthy adolescents and young adults. Data suggest that reflecting on positive and negative daily events (e.g., via a photograph) and writing about the experiences have profound positive effects on a range of outcomes (e.g., grit, gratitude, functioning). In addition, the investigators intend to share the participants' photographs, stories, and advice on a website for other adolescents with SCD or cancer. Data indicate that prosocial behavior (e.g., providing advice to peers) and social connectedness have a number of positive outcomes. The central prediction is that FOCUS will be acceptable and feasible to deliver and that pilot data will reveal improvements in participants' psychosocial health. Achieving these aims will provide the foundational data needed for federal grant applications to evaluate FOCUS with a larger pediatric sample and other patient populations, powered to identify outcomes and mechanisms of change.
Aim. Pilot FOCUS. A pilot randomized controlled trial will compare FOCUS to standard care. Investigators will randomize a total of 60 12- to 18-year-old patients to either FOCUS intervention (n=15 with SCD; n=15 with cancer) or treatment as usual (n=15 with SCD; n=15 with cancer). Randomization will be stratified to match patients based on age, sex, and medical condition (SCD type, cancer type). FOCUS participants will engage in the intervention and complete measures for 10 days post hospital discharge. Control participants will complete similar measures but not receive the intervention. Mixed qualitative and quantitative measures of feasibility, acceptability, and preliminary outcomes will be conducted to evaluate both the intervention and study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| FOCUS | Experimental | Behavioral: FOCUSParticipants will complete a baseline survey battery and learn about The Hero's Journey. Starting at hospital discharge for 10 days, they will do the following: 1) identify which stage of The Hero's Journey they are experiencing; 2) take a picture of something good and write a caption describing the picture and provide advice; and 3) take a picture of something difficult or challenging during the day and write a caption for the photo and provide advice. Daily text messages will remind participants to take the photographs, write the advice captions, upload both to the server, as well as to take a very brief daily survey. At the conclusion of day 10, participants will be asked to review their photos and captions and provide final advice in the form of a letter to other adolescents with SCD or cancer. Finally, they will complete a post-intervention battery. |
| Control | No intervention | –In a 30-min visit (in person or virtual) with adolescents during hospitalizations, we will have participants complete a baseline survey battery. Daily text messages will remind participants to take a very brief daily survey. At the conclusion of day 10, participants will complete a post-intervention battery. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 1) diagnosis of sickle cell disease, any hemoglobin type or diagnosis of leukemia, lymphoma, or solid tumor
- 2) inpatient at CHOA
- 3) 12-18 years of age
- 4) English speaking
- 5) owns a smartphone with camera.
Key exclusion criteria (2 listed)
- 1) report of active psychosis or active suicidal ideation in the adolescents
- 2) significant documented developmental delay, autism spectrum disorder, or significant intellectual impairment, as these comorbidities may confound the study aims by impacting the dependent measures.
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 |
|---|---|---|
| FOCUSSee prior section. | Behavioural | FOCUS |
Primary outcome
Life Satisfaction
Time frame: Change from baseline to post-intervention at 10 days
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v1.0 - Life Satisfaction - Short Form 8a; Forrest, C. B., Devine, J., Bevans, K. B., Becker, B. D., Carle, A. C., Teneralli, R. E., … Ravens-Sieberer, U. (2018). Development and psychometric evaluation of the PROMIS Pediatric Life Satisfaction item banks, child-report, and parent-proxy editions. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 27(1), 217-234. doi:10.1007/s11136-017-1681-7; Scores range from 8-40, with higher scores representing more life satisfaction
Depression
Time frame: Change from baseline to post-intervention at 10 days
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Depressive Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more depression
Anxiety
Time frame: Change from baseline to post-intervention at 10 days
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Anxiety Symptoms - Short Form 8a; Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., … DeWalt, D. A. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 19(4), 595-607. doi:10.1007/s11136-010-9619-3; Scores range from 8-40, with higher scores representing more anxiety
Meaning and Purpose
Time frame: Change from baseline to post-intervention at 10 days
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Meaning and Purpose - Short Form 8a; Christopher B Forrest, Katherine B Bevans, Ania Filus, Janine Devine, Brandon D Becker, Adam C Carle, Rachel E Teneralli, JeanHee Moon, Ulrike Ravens-Sieberer, Assessing Children's Eudaimonic Well-Being: The PROMIS Pediatric Meaning and Purpose Item Banks, Journal of Pediatric Psychology, jsz046, https://doi.org/10.1093/jpepsy/jsz046; Scores range from 8-40, with higher scores representing more meaning and purpose
Positive Affect
Time frame: Change from baseline to post-intervention at 10 days
PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Item Bank v2.0 - Positive Affect - Short Form 8a; Forrest, C. B., Ravens-Sieberer, U., Devine, J., Becker, B. D., Teneralli, R., Moon, J., … Bevans, K. B. (2018). Development and Evaluation of the PROMIS® Pediatric Positive Affect Item Bank, Child-Report and Parent-Proxy Editions. Journal of happiness studies, 19(3), 699-718. doi:10.1007/s10902-016-9843-9; Scores range from 8-40, with higher scores representing more positive affect
Functional Disability
Time frame: Change from baseline to post-intervention at 10 days
Functional Disability Inventory (FDI)
Mindfulness
Time frame: Change from baseline to post-intervention at 10 days
Child and Adolescence Mindfulness Measure (CAMM)
Approach to Dealing with Adversity
Time frame: Change from baseline to post-intervention at 10 days
Shift and Persist Measure
2 secondary outcomes
Resilience
Time frame: Change from baseline to post-intervention at 10 days
Social Connectedness
Time frame: Change from baseline to post-intervention at 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
Lindsey L Cohen, PhD principal investigator
Georgia State University
Laura G McKee principal investigator
Georgia State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCUS in people with Pediatric Cancer and Sickle Cell Disease, run by Georgia State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura G McKee, PhD (802-5789075, lmckee1@gsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life Satisfaction (time frame: Change from baseline to post-intervention at 10 days). The study lists 8 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 13 Nov 2020.