Breast CarcinomaNCT02192333
Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors
A study testing Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration in people with Breast Carcinoma and Cancer Survivor, run by Fred Hutchinson Cancer Center at 6 sites in United States.
Trial summary
This randomized clinical trial studies survivorship care in reducing symptoms in young adult cancer survivors. Survivorship care programs that identify the needs of young adult cancer survivors and ways to support them through the years after treatment may help reduce symptoms, such as pain, fatigue, sleep… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Breast Carcinoma, Cancer Survivor, Depression
- What is being tested?
- Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Aug 2015to 31 Dec 2019
- 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 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients enrolled on phase 1 of the study are eligible (and/or if recruited from tumor registry or clinic follow-up schedules)
- Diagnosed with invasive malignancy including: breast, gastrointestinal track, female or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphoma
- Treated at one of the Survivorship Centers of Excellence or their community affiliates
- Received a therapeutic intervention with at least one of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any modality)
- Currently between 1.0 and 4.99 years from the completion of active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention)
- Patient must still be in active follow-up: seen for a follow-up visit in the participating center at least once in the 3 years prior to enrollment and/or scheduled to be seen for follow-up in the next 6 months (i.e. in active follow-up)
- May be receiving "maintenance" therapy that has a goal of prevention of recurrence but there should be no expectations for further active treatment
- Able to read and speak English adequate to complete the patient-reported outcomes (PRO) assessment
Who cannot join
- Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)
This randomized clinical trial studies survivorship care in reducing symptoms in young adult cancer survivors. Survivorship care programs that identify the needs of young adult cancer survivors and ways to support them through the years after treatment may help reduce symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the impact of providing the essential elements of survivorship care on survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer between the ages of 18 and 39 years when compared with usual care.
SECONDARY OBJECTIVES:
- To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.
II. To provide evidence on barriers, needs and care preferences that will support long term follow-up recommendations for this population.
OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants categorized as low-need are assigned to Arm I.
ARM I: Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
ARM II: Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit.
After completion of study, participants are followed up at 6 and 12 months.
- Conditions
- Breast Carcinoma, Cancer Survivor, Depression, Fatigue, Leukemia, Lymphoma
- Being tested
- Management of Therapy Complications, Quality-of-Life Assessment, Questionnaire Administration, Telephone-Based Intervention
- Medical subject headings
- Breast Neoplasms, Depression, Fatigue, Leukemia, Lymphoma, Bone Neoplasms, Gastrointestinal Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Therapy ComplicationsProcedure or surgery
Receive survivorship care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive phone-based booster intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | No intervention | Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II. |
| Arm II (survivorship care) | Experimental | Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit. Receives: Procedure: Management of Therapy Complications; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey
Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.
Measured: At 6 months
Secondary outcomes (20)
Barriers to health care assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Change in depression assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
Measured: Baseline to up to 12 months
Change in distress assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
Measured: Baseline to up to 12 months
Change in fatigue assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
Measured: Baseline to up to 12 months
Change in pain assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
Measured: Baseline to up to 12 months
Change in sleep assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.
Measured: Baseline to up to 12 months
Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
General health assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Health behaviors assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Health care utilization assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Medications assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Mood and worries assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Neuropathy assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Quality of life assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Reclassification of subject from high need to low need
Reclassification of subject from high need to low need is defined as the high need subject no longer has scores above the cut-off level on 2 or more symptoms scales (depression, distress, insomnia, fatigue, pain) assessed using the PRO survey. The 5 symptom scales are categorized based on the following cut points to define "high need": pain score >= 5, fatigue score >= 3, insomnia score of no insomnia, distress score > 1.1, and depression score >= 10.
Measured: At 6 months
Reproductive health assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Sexual function assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Social support assessed using the patient-reported outcomes (PRO) survey
Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start3 Aug 2015
- Primary completion7 Oct 2017
- Study completion31 Dec 2019
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 Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Livestrong Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- K. Scott Baker, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192333
- Sponsor's protocol ID
- 9161
- Other IDs
- NCI-2014-01325, 9161, P30CA015704, RG1001123
- Status last verified
- Oct 2020
- First submitted
- 15 Jul 2014
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hall AG, Syrjala KL, Ketterl TG, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Rajotte EJ, Mueller BA, Baker KS. Socioeconomic Factors and Adherence to Health Care Recommendations in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2023 Oct;12(5):701-709. doi: 10.1089/jayao.2022.0109. Epub 2023 Feb 13.
PubMed 36779982Syrjala KL, Walsh CA, Yi JC, Leisenring WM, Rajotte EJ, Voutsinas J, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Baker KS. Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms. J Cancer Surviv. 2022 Oct;16(5):1149-1164. doi: 10.1007/s11764-021-01105-8. Epub 2021 Sep 29.
PubMed 34590205
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adult Cancer Survivor Network Study of the Essential Elements of Care (YA-EEC-14)
- ClinicalTrials.gov ID
- NCT02192333
- Acronym / sponsor ID
- 9161
- Conditions
- Breast Carcinoma, Cancer Survivor, Depression, Fatigue, Leukemia, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Livestrong Foundation, National Cancer Institute (NCI)
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 7 Oct 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Jul 2014 (estimated)
- 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 randomized clinical trial studies survivorship care in reducing symptoms in young adult cancer survivors. Survivorship care programs that identify the needs of young adult cancer survivors and ways to support them through the years after treatment may help reduce symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To test the impact of providing the essential elements of survivorship care on survivorship outcomes as indicated by reduction in symptoms (pain, fatigue, sleep disturbance, depression, distress) in young adult cancer survivors diagnosed with cancer between the ages of 18 and 39 years when compared with usual care.
SECONDARY OBJECTIVES:
- To improve confidence in survivorship knowledge and promote healthy lifestyle behaviors.
II. To provide evidence on barriers, needs and care preferences that will support long term follow-up recommendations for this population.
OUTLINE: Participants categorized as high-need are randomized to 1 of 2 arms. Participants categorized as low-need are assigned to Arm I.
ARM I: Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II.
ARM II: Participants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit.
After completion of study, participants are followed up at 6 and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | No intervention | –Participants receive usual care. After 12 months, participants may receive a survivorship clinic visit and boosters as in Arm II. |
| Arm II (survivorship care) | Experimental | Procedure: Management of Therapy Complications, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants attend a survivorship clinic visit that includes care plans, screening recommendations, physician coordination, health promotion education, symptom management and palliative care, late effects education, psychosocial and medical assessments, and referrals for services and care as appropriate. Participants also receive phone-based survivorship boosters over approximately 15-30 minutes at 4-8 weeks and 12-16 weeks after the initial clinic visit. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients enrolled on phase 1 of the study are eligible (and/or if recruited from tumor registry or clinic follow-up schedules)
- Diagnosed with invasive malignancy including: breast, gastrointestinal track, female or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphoma
- Treated at one of the Survivorship Centers of Excellence or their community affiliates
- Received a therapeutic intervention with at least one of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any modality)
- Currently between 1.0 and 4.99 years from the completion of active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention)
Key exclusion criteria (1 listed)
- Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan
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 |
|---|---|---|
| Management of Therapy ComplicationsReceive survivorship care | Procedure or surgery | Arm II (survivorship care) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm II (survivorship care) |
| Questionnaire AdministrationAncillary studies | Other | Arm II (survivorship care) |
| Telephone-Based InterventionReceive phone-based booster intervention | Behavioural | Arm II (survivorship care) |
Primary outcome
Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey
Time frame: At 6 months
Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.
20 secondary outcomes
Barriers to health care assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Change in depression assessed using the patient-reported outcomes (PRO) survey
Time frame: Baseline to up to 12 months
Change in distress assessed using the patient-reported outcomes (PRO) survey
Time frame: Baseline to up to 12 months
Change in fatigue assessed using the patient-reported outcomes (PRO) survey
Time frame: Baseline to up to 12 months
Change in pain assessed using the patient-reported outcomes (PRO) survey
Time frame: Baseline to up to 12 months
Change in sleep assessed using the patient-reported outcomes (PRO) survey
Time frame: Baseline to up to 12 months
Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
General health assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Health behaviors assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Health care utilization assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Medications assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Mood and worries assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Neuropathy assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Quality of life assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Reclassification of subject from high need to low need
Time frame: At 6 months
Reproductive health assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Sexual function assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
Social support assessed using the patient-reported outcomes (PRO) survey
Time frame: Up to 12 months
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 9 Oct 2020.
- Derived from this study: PubMed 36779982Hall AG, Syrjala KL, Ketterl TG, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Rajotte EJ, Mueller BA, Baker KS. Socioeconomic Factors and Adherence to Health Care Recommendations in Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2023 Oct;12(5):701-709. doi: 10.1089/jayao.2022.0109. Epub 2023 Feb 13.
- Derived from this study: PubMed 34590205Syrjala KL, Walsh CA, Yi JC, Leisenring WM, Rajotte EJ, Voutsinas J, Ganz PA, Jacobs LA, Palmer SC, Partridge A, Baker KS. Cancer survivorship care for young adults: a risk-stratified, multicenter randomized controlled trial to improve symptoms. J Cancer Surviv. 2022 Oct;16(5):1149-1164. doi: 10.1007/s11764-021-01105-8. Epub 2021 Sep 29.
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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.
K. Scott Baker principal investigator
Fred Hutch/University of Washington Cancer Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of Therapy Complications, Quality-of-Life Assessment and Questionnaire Administration in people with Breast Carcinoma and Cancer Survivor, run by Fred Hutchinson Cancer Center at 6 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 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Mean of the two z scores of the two highest scores for the symptoms that determined the participant's eligibility as "high need" assessed using patient-reported outcomes (PRO) survey (time frame: At 6 months). 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 NCT02192333, 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 9 Oct 2020.