HIVNCT02108028
Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer
An observational study of HIV and Cancer, run by National Cancer Institute (NCI) at 9 sites in United States.
Trial summary
Background: There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Cancer, Chronic Granulomatous Disease
- How many people
- 272 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Apr 2014to 24 Jul 2024
- Phase
- Observational
- 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
Study population: Patients between 18-39 must be diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. Non-Patient participants must be family/friend and/or health care providers of patients diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
Who may be able to join
- Patients must be between ages: 18 through 39 years
- Patients must be diagnosed with cancer or other chronic illness.
- Patients must give informed consent.
- Patients must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS; Appendix
- Patients must be English or Spanish speaking.
- Cohorts 1B and 2B must be English speaking only.
Show all 9Show fewer
- Subject must be greater than or equal to 18 years of age
- Family/friend and/or health care providers must be English or Spanish speaking.
- Family/friend and health care providers must provide informed consent.
Who cannot join
- Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
- Cognitive impairment which in the judgment of the Principal or Associate Investigatorwould compromise the patient s ability to understand the VMC material or is likely to interfere with the study procedures or results.
- Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate or complete this study.
- Participants who have already completed the Voicing My CHOiCES tool.
- ELIGIBILITY CRITERIA FOR NON-PATIENT PARTICPANTS (COHORT 4):
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Cook Childrens Hospital
Fort Worth, Texas, 76104
Children's Hospital of Orange County
Orange, California, 92868
Rhode Island Hospital (Lifespan)
Providence, Rhode Island, 02903
Moffitt Cancer Center
Tampa, Florida, 33647
Children's Hospital at Montefiore
The Bronx, New York, 10467
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: An Exploratory Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer and Other Chronic Illnesses
Background:
- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful.
Read more
Objective:
- To study if Voicing My CHOiCES(TM) can reduce anxiety, improve sense of support, and improve communication about advanced care planning.
Eligibility:
- Adults 18 to 39 years old being treated for cancer.
Design:
- Participants will answer questions about their age, sex, employment, religion, health, and marital status. They will also complete several brief questionnaires:
- General Anxiety Short Form
- Peace, Equanimity and Acceptance in the Cancer Experience
- Functional Assessment of Social Support
- Quality of Communication
- Prior Communication about Advanced Care Planning
- Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations.
- The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.
Read the detailed description
Background:
Discussing end-of-life (EoL) care is very challenging for young adults (YA) living with a life-threatening disease.
While many helpful documents exist to facilitate EoL conversations with adults, few resources exist to aid YA in understanding and accepting their changing physical, emotional and social needs when treatment is no longer effective.
Between 2007-2011, the Pediatric Oncology Branch (07-C-0085) explored the helpfulness of Five Wishes with adolescents and young adults living with HIV or advanced cancer. This research led to the development of a new advance care planning (ACP) guide, Voicing My CHOiCES (VMC). However, Voicing My CHOiCES has not been empirically examined in its completed form.
Objectives:
To determine the perceived helpfulness of VMC.
To determine whether engaging in advanced care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness, and/or improved communication about ACP with family, friends, and/or health care providers.
To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.
Eligibility:
Patient Participants:
Age: 18 through 39 years
Known cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
No prior experience using Voicing My CHOiCES
Participants enrolled to assess the helpfulness of changes made to original VMC must be English speaking.
Patients and family/friend and health care providers must be English or Spanish speaking.
Design:
Each subject will complete a baseline assessment of their anxiety pertaining to advance care planning, quality of social support, acceptance of illness, and quality of communication with family, friends and health care providers. They will be asked to review the advance care planning document, Voicing My CHOiCES , and to comment on each section as to whether it can provide an opportunity to address ACP needs for themselves and for other YA their age living with a serious illness. They will also assess whether revisions are needed to the document.
To obtain the perspectives of different YA, the initial study arm included 200 participants, 27 YA who were living independently, 42 YA who have a child(ren) of their own, and 81 YA who neither lived independently or had child(ren). In addition, up to 50 family/friends and health care providers of the participants participated in the follow up assessment. Arm 2 will include up to 80 participants recruited, at the Clinical Center, The Johns Hopkins Hospital, and Rhode Island Hospital (Lifespan) to compare the original Voicing My CHOiCES to the revised document. A total of up to 280 individuals may participate in this study.
A 1-month pre-post design will be used to assess the utility of the document, anxiety, quality of social support, acceptance of illness, communication about EoL planning, and whether the patient participant has shared any of the work completed in the document with a family member, friend, or health care provider.
If the participant had shared the ACP preferences that were documented in Voicing My CHOiCES with a family member or friend, and had consented for us to contact that person, we will obtain the family member or friend s consent and complete a brief interview assessing the helpfulness and limitations of Voicing My CHOiCES for ACP. If the participant had shared the ACP preferences that were documented in Voicing My CHOiCES with their health care provider and had consented for us to talk with that health care provider, a brief interview assessing the helpfulness and limitations of Voicing My CHOiCES for end-of-life planning and whether any changes in the participants health care was made in response to Voicing My CHOiCES , will be documented.
- Conditions
- HIV, Cancer, Chronic Granulomatous Disease, Dock 8 Deficiency
- Keywords
- Advance Care Planning Guide, End of life, Natural History
- Medical subject headings
- Neoplasms, Granulomatous Disease, Chronic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A / Initial Young Adults with Children | Young adults who have a child(ren) and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE | |
| Cohort 1B / Comparison Young Adults with Children | Young adults who have children and are 18- 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. | |
| Cohort 2A / Initial Independent Young Adults | Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE | |
| Cohort 2B / Comparison Independent Young Adults | Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. | |
| Cohort 3A / Initial Young Adults No Children, Not Independent | Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE | |
| Cohort 3B / Comparison Young Adults No Children, Not Independent | Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. | |
| Cohort 4 / Non-patient participants | Family members, friends, or health care providers of patient participant. COMPLETE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived helpfulness
To determine whether engaging in advance care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness and/or improved communication about ACP with family, friends and/or health care providers.
Measured: 2 months
Improved outcomes
To determine whether engaging in advanced care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness, and/or improved communication about ACP with family, friends, and/or health care providers.
Measured: 2 months
Feasability
To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.
Measured: 2 months
Secondary outcomes (3)
Helpfullness vs living & parental status
To examine the helpfulness of VMC by living status (independent living vs. with family of origin) and parental status.
Measured: 2 months
Feasibility
To assess whether further revisions are needed to VMC for use with YA.
Measured: 2 months
Benefit vs burden
To examine the perceived benefit and burden of completing VMC.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study start3 Apr 2014
- Primary completion16 Aug 2023
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brian W Pennarola, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108028
- Sponsor's protocol ID
- 140079
- Other IDs
- 14-C-0079
- Status last verified
- 9 Jun 2026
- First submitted
- 5 Apr 2014
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. doi: 10.1016/s0031-3955(02)00035-4.
PubMed 12430624Bellizzi KM, Smith A, Schmidt S, Keegan TH, Zebrack B, Lynch CF, Deapen D, Shnorhavorian M, Tompkins BJ, Simon M; Adolescent and Young Adult Health Outcomes and Patient Experience (AYA HOPE) Study Collaborative Group. Positive and negative psychosocial impact of being diagnosed with cancer as an adolescent or young adult. Cancer. 2012 Oct 15;118(20):5155-62. doi: 10.1002/cncr.27512. Epub 2012 Mar 13.
PubMed 22415815Nilsson ME, Maciejewski PK, Zhang B, Wright AA, Trice ED, Muriel AC, Friedlander RJ, Fasciano KM, Block SD, Prigerson HG. Mental health, treatment preferences, advance care planning, location, and quality of death in advanced cancer patients with dependent children. Cancer. 2009 Jan 15;115(2):399-409. doi: 10.1002/cncr.24002.
PubMed 19110677
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer and Other Chronic Illnesses
- ClinicalTrials.gov ID
- NCT02108028
- Acronym / sponsor ID
- 140079
- Conditions
- HIV, Cancer, Chronic Granulomatous Disease, Dock 8 Deficiency
- Keywords
- Advance Care Planning Guide, End of life, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 9 Apr 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.
Background:
- There are very few documents to help young adults living with advanced cancer discuss their concerns and end-of-life preferences. A new document, Voicing My CHOiCES, allows young adults to explain what kind of care they would want if they became unable to communicate or make medical decisions on their own. Researchers want to study if this document is helpful.
Objective:
- To study if Voicing My CHOiCES(TM) can reduce anxiety, improve sense of support, and improve communication about advanced care planning.
Eligibility:
- Adults 18 to 39 years old being treated for cancer.
Design:
- Participants will answer questions about their age, sex, employment, religion, health, and marital status. They will also complete several brief questionnaires:
- General Anxiety Short Form
- Peace, Equanimity and Acceptance in the Cancer Experience
- Functional Assessment of Social Support
- Quality of Communication
- Prior Communication about Advanced Care Planning
- Then a health care professional will introduce Voicing My CHOiCES . Participants will review the document and comment on parts they find relevant. They will also say if any important items are missing. Participants will complete 3 pages of the document with the assistance of a health care provider. They will be asked for positive and negative observations.
- The second stage of the study will take place about 1 month later. Participants will repeat the brief questionnaires listed above. They will be asked if they shared any of the preferences they described when completing the 3 pages of Voicing My CHOiCES during visit 1 with a family member, friend, or health care provider. Research staff will ask the participant for permission to contact the people they spoke with in order to learn whether their conversations about the document were helpful. They will ask for feedback on how to make Voicing My CHOiCES more helpful.
Detailed description
Background:
Discussing end-of-life (EoL) care is very challenging for young adults (YA) living with a life-threatening disease.
While many helpful documents exist to facilitate EoL conversations with adults, few resources exist to aid YA in understanding and accepting their changing physical, emotional and social needs when treatment is no longer effective.
Between 2007-2011, the Pediatric Oncology Branch (07-C-0085) explored the helpfulness of Five Wishes with adolescents and young adults living with HIV or advanced cancer. This research led to the development of a new advance care planning (ACP) guide, Voicing My CHOiCES (VMC). However, Voicing My CHOiCES has not been empirically examined in its completed form.
Objectives:
To determine the perceived helpfulness of VMC.
To determine whether engaging in advanced care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness, and/or improved communication about ACP with family, friends, and/or health care providers.
To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.
Eligibility:
Patient Participants:
Age: 18 through 39 years
Known cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
No prior experience using Voicing My CHOiCES
Participants enrolled to assess the helpfulness of changes made to original VMC must be English speaking.
Patients and family/friend and health care providers must be English or Spanish speaking.
Design:
Each subject will complete a baseline assessment of their anxiety pertaining to advance care planning, quality of social support, acceptance of illness, and quality of communication with family, friends and health care providers. They will be asked to review the advance care planning document, Voicing My CHOiCES , and to comment on each section as to whether it can provide an opportunity to address ACP needs for themselves and for other YA their age living with a serious illness. They will also assess whether revisions are needed to the document.
To obtain the perspectives of different YA, the initial study arm included 200 participants, 27 YA who were living independently, 42 YA who have a child(ren) of their own, and 81 YA who neither lived independently or had child(ren). In addition, up to 50 family/friends and health care providers of the participants participated in the follow up assessment. Arm 2 will include up to 80 participants recruited, at the Clinical Center, The Johns Hopkins Hospital, and Rhode Island Hospital (Lifespan) to compare the original Voicing My CHOiCES to the revised document. A total of up to 280 individuals may participate in this study.
A 1-month pre-post design will be used to assess the utility of the document, anxiety, quality of social support, acceptance of illness, communication about EoL planning, and whether the patient participant has shared any of the work completed in the document with a family member, friend, or health care provider.
If the participant had shared the ACP preferences that were documented in Voicing My CHOiCES with a family member or friend, and had consented for us to contact that person, we will obtain the family member or friend s consent and complete a brief interview assessing the helpfulness and limitations of Voicing My CHOiCES for ACP. If the participant had shared the ACP preferences that were documented in Voicing My CHOiCES with their health care provider and had consented for us to talk with that health care provider, a brief interview assessing the helpfulness and limitations of Voicing My CHOiCES for end-of-life planning and whether any changes in the participants health care was made in response to Voicing My CHOiCES , will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A / Initial Young Adults with Children | – | –Young adults who have a child(ren) and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE |
| Cohort 1B / Comparison Young Adults with Children | – | –Young adults who have children and are 18- 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. |
| Cohort 2A / Initial Independent Young Adults | – | –Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE |
| Cohort 2B / Comparison Independent Young Adults | – | –Young adults who live independently and are 18-39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. |
| Cohort 3A / Initial Young Adults No Children, Not Independent | – | –Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. COMPLETE |
| Cohort 3B / Comparison Young Adults No Children, Not Independent | – | –Young adults with no children, not living independently who are 18-39 diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. |
| Cohort 4 / Non-patient participants | – | –Family members, friends, or health care providers of patient participant. COMPLETE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18-39 must be diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at a participating site. Non-Patient participants must be family/friend and/or health care providers of patients diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
Key inclusion criteria (9 listed)
- Patients must be between ages: 18 through 39 years
- Patients must be diagnosed with cancer or other chronic illness.
- Patients must give informed consent.
- Patients must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS; Appendix
- Patients must be English or Spanish speaking.
Key exclusion criteria (5 listed)
- Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the patient s ability to engage in the intervention or is likely to interfere with the study procedures or results.
- Cognitive impairment which in the judgment of the Principal or Associate Investigatorwould compromise the patient s ability to understand the VMC material or is likely to interfere with the study procedures or results.
- Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the research team would compromise the patient s ability to tolerate or complete this study.
- Participants who have already completed the Voicing My CHOiCES tool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived helpfulness
Time frame: 2 months
To determine whether engaging in advance care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness and/or improved communication about ACP with family, friends and/or health care providers.
Improved outcomes
Time frame: 2 months
To determine whether engaging in advanced care planning using VMC is associated with reduced anxiety, improved social support, increased acceptance of illness, and/or improved communication about ACP with family, friends, and/or health care providers.
Feasability
Time frame: 2 months
To assess the helpfulness of the changes made to the original VMC as compared to the revised VMC document.
3 secondary outcomes
Helpfullness vs living & parental status
Time frame: 2 months
Feasibility
Time frame: 2 months
Benefit vs burden
Time frame: 2 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 26 Oct 2026.
- Background: PubMed 12430624Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42. doi: 10.1016/s0031-3955(02)00035-4.
- Background: PubMed 22415815Bellizzi KM, Smith A, Schmidt S, Keegan TH, Zebrack B, Lynch CF, Deapen D, Shnorhavorian M, Tompkins BJ, Simon M; Adolescent and Young Adult Health Outcomes and Patient Experience (AYA HOPE) Study Collaborative Group. Positive and negative psychosocial impact of being diagnosed with cancer as an adolescent or young adult. Cancer. 2012 Oct 15;118(20):5155-62. doi: 10.1002/cncr.27512. Epub 2012 Mar 13.
- Background: PubMed 19110677Nilsson ME, Maciejewski PK, Zhang B, Wright AA, Trice ED, Muriel AC, Friedlander RJ, Fasciano KM, Block SD, Prigerson HG. Mental health, treatment preferences, advance care planning, location, and quality of death in advanced cancer patients with dependent children. Cancer. 2009 Jan 15;115(2):399-409. doi: 10.1002/cncr.24002.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
Brian W Pennarola, M.D. principal investigator
National Cancer Institute (NCI)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Cancer, run by National Cancer Institute (NCI) at 9 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 9 inclusion and 5 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Perceived helpfulness (time frame: 2 months). The study lists 3 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 NCT02108028, which also lists 3 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 26 Oct 2026.