Protocol Number: 07-C-0085

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 Disease

Number:

07-C-0085

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.

-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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

-Age: 16 to 30 years

-Patients must be enrolled in an active protocol at the NIH and 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 perinatalor early life transfusion associated HIV infection. The treatment protocol PI 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.

EXCLUSION CRITERIA:

-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

Special Instructions:

Currently Not Provided

Keywords:

End-of-Life

Advance Directive

Pediatric Cancer

Adolescents

Young Adults

Recruitment Keyword(s):

Pediatric Cancer

Young Adults

End-of-Life

Condition(s):

Neoplasms

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

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.

Mack 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. Review.

Hammes BJ, Klevan J, Kempf M, Williams MS. Pediatric advance care planning. J Palliat Med. 2005 Aug;8(4):766-73.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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