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Protocol Details

An Exploratory Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults with Cancer and Other Chronic Illnesses

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-C-0079

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Adults who are or may become unable to consent

Keywords

Advance Care Planning Guide;
End of life;
Natural History

Recruitment Keyword(s)

None

Condition(s)

HIV;
Cancer;
Chronic Granulomatous Disease;
Dock 8 Deficiency

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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 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, gender, employment, religion, health, and marital status. They will also complete several brief questionnaires:

1.General Anxiety Short Form

2.Peace, Equanimity and Acceptance in the Cancer Experience

3.Functional Assessment of Social Support

4.Quality of Communication

5.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.

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Eligibility

ELIGIBILITY CRITERIA FOR PATIENT PARTICIPANTS (COHORT 1A, 1B, 2A, 2B, 3A & 3B):

INCLUSION CRITERIA:

-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.

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.

-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):

INCLUSION CRITERIA:

-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.


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Citations:

Bleyer A. Older adolescents with cancer in North America deficits in outcome and research. Pediatr Clin North Am. 2002 Oct;49(5):1027-42.

Bellizzi 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.

Nilsson 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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lori Wiener, Ph.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1-6466
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6419
lori.wiener@nih.gov

Lori Wiener, Ph.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 1-6466
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6419
lori.wiener@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02108028

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