NeoplasmsNCT01445145
An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection
An observational study of Neoplasms, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Background: Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Neoplasms
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2007to 25 Sep 2014
- 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 16 to 30 years
- Patients at NIH or participating site must have 1) a diagnosis of metastatic, recurrent, or progressive cancer with a mean survival rate of 2 years or less or 2) a diagnosis of perinatal or early life transfusion associated HIV infection. The treatment protocol PI or attending physician must consent to have a patient entered into this protocol. Newly diagnosed patients must have completed at least three cycles of chemotherapy.
- For patients less than 18 years of age, a legal guardian must provide informed consent and the patients must sign an assent document.
- Patients greater than 18 years of age must give informed consent.
- Patients less than 18 years of age must have a score of 40 or higher on Lanksy/Karnofsky, as determined by the medical team at the time of enrollment.
- Patients greater than 18 years of age must have a score of 3 or less on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) at the time of enrollment.
- Patients must be English or Spanish speaking.
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.
- Previously identified cognitive impairment which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to understand the Five Wishes 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 this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
Georgetown University
Washington D.C., District of Columbia, 20007-2197
About this study
Background:
- Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective.
- An advance directive document called Five Wishes has had particular success with the adult population because of the consideration of personal, emotional and spiritual needs in addition to medical and legal concerns.
Read more
Objectives:
-To learn which questions in Five Wishes are useful for adolescents and young adults and to then create a new document that reflects the issues they feel are most appropriate for people with cancer or HIV disease.
Eligibility:
-Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.
Design:
- Stage 1: Participants go through each question in Five Wishes and respond to whether they feel the questions are useful.
- Stage 2: Participants are asked to compare each question from Five Wishes to a newly developed document based on the feedback received during first stage of the study.
- Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter the study.
Read the detailed description
Background:
- Discussing end of life (EoL) care with adolescents and young adults can be one of the most difficult aspects of living with a life threatening disease.
- Few established resources exist to aid this population in accepting and understanding their changing physical, emotional and social needs when treatment is no longer effective. Standards in palliative care suggest that discussion of end of life issues be routine and commence soon after diagnosis.
- While many helpful documents exist to facilitate such conversations with adults, few address the particular concerns and needs of adolescents and young adults.
- One advance directive (AD) document, Five Wishes, has had particular success with the adult population because of the consideration of 'personal, emotional and spiritual needs' in addition to medical and legal concerns.
Objective:
- To determine if adolescents and young adults living with advanced cancer or HIV disease feel that an AD document, such as Five Wishes, is useful in addressing end of life issues.
- To develop and perform a pilot evaluation of a modified age-appropriate advance care planning tool for young adults and adolescents based on Five Wishes that reflects the participants opinions on which questions they feel are most useful and additional items that might be helpful.
Eligibility:
- Age: 16 to 30 years
- Known metastatic, progressive or recurrent cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.
Design:
-A descriptive study of attitudes of young adults (16-30 years) with cancer or HIV disease concerning the questions contained in the AD document Five Wishes as well as a comparison between Five Wishes and a modified version of that document.
- Conditions
- Neoplasms
- Keywords
- End-of-Life, Advance Directive, Pediatric Cancer, Adolescents, Young Adults
- Medical subject headings
- Neoplasms, Death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start26 Jan 2007
- Study completion25 Sep 2014
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 NeoplasmsStudies 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
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lori Wiener, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445145
- Sponsor's protocol ID
- 070085
- Other IDs
- 07-C-0085
- Status last verified
- 25 Sep 2014
- First submitted
- 30 Sep 2011
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC. Symptoms and suffering at the end of life in children with cancer. N Engl J Med. 2000 Feb 3;342(5):326-33. doi: 10.1056/NEJM200002033420506.
PubMed 10655532Mack JW, Wolfe J. Early integration of pediatric palliative care: for some children, palliative care starts at diagnosis. Curr Opin Pediatr. 2006 Feb;18(1):10-4. doi: 10.1097/01.mop.0000193266.86129.47.
PubMed 16470155Hammes BJ, Klevan J, Kempf M, Williams MS. Pediatric advance care planning. J Palliat Med. 2005 Aug;8(4):766-73. doi: 10.1089/jpm.2005.8.766.
PubMed 16128650
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Use of Five Wishes as a Tool for Advanced Care Planning in Young Adults With Metastatic, Recurrent, or Progressive Cancer or HIV Infection
- ClinicalTrials.gov ID
- NCT01445145
- Acronym / sponsor ID
- 070085
- Conditions
- Neoplasms
- Keywords
- End-of-Life, Advance Directive, Pediatric Cancer, Adolescents, Young Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Jan 2007
- Study completion
- 25 Sep 2014
- First posted
- 3 Oct 2011 (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:
- Few resources exist for helping adolescents and young adults with cancer or HIV disease understand their changing physical, emotional and social needs when treatment is no longer effective.
- An advance directive document called Five Wishes has had particular success with the adult population because of the consideration of personal, emotional and spiritual needs in addition to medical and legal concerns.
Objectives:
-To learn which questions in Five Wishes are useful for adolescents and young adults and to then create a new document that reflects the issues they feel are most appropriate for people with cancer or HIV disease.
Eligibility:
-Adolescents and young adults 16 to 30 years of age with advanced cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.
Design:
- Stage 1: Participants go through each question in Five Wishes and respond to whether they feel the questions are useful.
- Stage 2: Participants are asked to compare each question from Five Wishes to a newly developed document based on the feedback received during first stage of the study.
- Participants are enrolled for either Stage 1 or Stage 2 depending on the date they enter the study.
Detailed description
Background:
- Discussing end of life (EoL) care with adolescents and young adults can be one of the most difficult aspects of living with a life threatening disease.
- Few established resources exist to aid this population in accepting and understanding their changing physical, emotional and social needs when treatment is no longer effective. Standards in palliative care suggest that discussion of end of life issues be routine and commence soon after diagnosis.
- While many helpful documents exist to facilitate such conversations with adults, few address the particular concerns and needs of adolescents and young adults.
- One advance directive (AD) document, Five Wishes, has had particular success with the adult population because of the consideration of 'personal, emotional and spiritual needs' in addition to medical and legal concerns.
Objective:
- To determine if adolescents and young adults living with advanced cancer or HIV disease feel that an AD document, such as Five Wishes, is useful in addressing end of life issues.
- To develop and perform a pilot evaluation of a modified age-appropriate advance care planning tool for young adults and adolescents based on Five Wishes that reflects the participants opinions on which questions they feel are most useful and additional items that might be helpful.
Eligibility:
- Age: 16 to 30 years
- Known metastatic, progressive or recurrent cancer or HIV disease acquired perinatally or early in life and enrolled in an active NIH treatment protocol.
Design:
-A descriptive study of attitudes of young adults (16-30 years) with cancer or HIV disease concerning the questions contained in the AD document Five Wishes as well as a comparison between Five Wishes and a modified version of that document.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 16 to 30 years
- Patients at NIH or participating site must have 1) a diagnosis of metastatic, recurrent, or progressive cancer with a mean survival rate of 2 years or less or 2) a diagnosis of perinatal or early life transfusion associated HIV infection. The treatment protocol PI or attending physician must consent to have a patient entered into this protocol. Newly diagnosed patients must have completed at least three cycles of chemotherapy.
- For patients less than 18 years of age, a legal guardian must provide informed consent and the patients must sign an assent document.
- Patients greater than 18 years of age must give informed consent.
- Patients less than 18 years of age must have a score of 40 or higher on Lanksy/Karnofsky, as determined by the medical team at the time of enrollment.
Key exclusion criteria (3 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.
- Previously identified cognitive impairment which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to understand the Five Wishes 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 this study
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
Not reported in the source record.
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 12 Dec 2019.
- Background: PubMed 10655532Wolfe J, Grier HE, Klar N, Levin SB, Ellenbogen JM, Salem-Schatz S, Emanuel EJ, Weeks JC. Symptoms and suffering at the end of life in children with cancer. N Engl J Med. 2000 Feb 3;342(5):326-33. doi: 10.1056/NEJM200002033420506.
- Background: PubMed 16470155Mack JW, Wolfe J. Early integration of pediatric palliative care: for some children, palliative care starts at diagnosis. Curr Opin Pediatr. 2006 Feb;18(1):10-4. doi: 10.1097/01.mop.0000193266.86129.47.
- Background: PubMed 16128650Hammes BJ, Klevan J, Kempf M, Williams MS. Pediatric advance care planning. J Palliat Med. 2005 Aug;8(4):766-73. doi: 10.1089/jpm.2005.8.766.
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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.
Lori Wiener, Ph.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by National Cancer Institute (NCI) 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 7 inclusion and 3 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 12 Dec 2019. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445145, 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 12 Dec 2019.