Study of Voicing My CHOiCES as a Tool for Advanced Care Planning in Young Adults With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02108028|
Recruitment Status : Recruiting
First Posted : April 9, 2014
Last Update Posted : April 8, 2021
- 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.
- To study if Voicing My CHOiCES can reduce anxiety, improve sense of support, and improve communication about advanced care planning.
- Adults 18 to 39 years old being treated for cancer.
Participants will answer questions about their age, gender, 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.
|Condition or disease|
|HIV Cancer Chronic Granulomatous Disease Dock 8 Deficiency|
|Study Type :||Observational|
|Estimated Enrollment :||280 participants|
|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|
|Actual Study Start Date :||April 3, 2014|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Cohort 1A / Initial Young Adults with Children
At least 25 young adults who have children and are 18 through 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
Cohort 1B / Comparison Young Adults with Children
At least 15 young adults who have children and are 18 through 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol.
Cohort 2A / Initial Independent Young Adults
At least 25 young adults who live independently and are 18 through 39 years diagnosed with cancer or other chronic illness and enrolled on an NIH protocol or treated at one of the participating sites.
Cohort 2B / Comparison Independent Young Adults
Up to 35 young adults who live independently and are 18 through 39 years diagnosed withcancer or other chronic illness and enrolled on an NIH protocol.
Cohort 3 / Non-patient participants
Up to 100 family members, friends, or health care providers of patient participant
- perceived helpfulness and create changes [ 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.
- Helpfulness vs living & parental status [ Time Frame: 2 Months ]To examine the helpfulness of VMC by living status (independent living vs. with family of origin) and parental status.
- Benefit vs Burden [ Time Frame: 2 Months ]To examine the perceived benefit and burden of completing VMC.
- Feasibility [ Time Frame: 2 Months ]To assess whether further revisions are needed to VMC for use with YA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108028
|Contact: Lori Wiener, Ph.D.||(240) firstname.lastname@example.org|
|United States, California|
|Children's Hospital of Orange County||Recruiting|
|Orange, California, United States, 92868|
|Contact: Leonard Sender 714-456-8025 email@example.com|
|United States, District of Columbia|
|Childrens National Medical Center||Recruiting|
|Washington, District of Columbia, United States|
|Contact: Maureen Lyon 202-476-5442 firstname.lastname@example.org|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33647|
|Contact: Kristine Donovan 813-745-1818 email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Karen Fasciano 617-632-6181 firstname.lastname@example.org|
|United States, New York|
|Children's Hospital at Montefiore||Recruiting|
|Bronx, New York, United States|
|Contact: Lisa Gennarini 718-741-2342 email@example.com|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7030|
|Contact: Lauren Lux 984-974-8686 firstname.lastname@example.org|
|United States, Texas|
|Cook Childrens Hospital||Recruiting|
|Fort Worth, Texas, United States, 76104|
|Contact: Corey Heath 682-885-2869 email@example.com|
|Principal Investigator:||Lori Wiener, Ph.D.||National Cancer Institute (NCI)|