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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06061965
Other study ID # 2023-0430
Secondary ID K99NR020358-01A1
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date January 31, 2025

Study information

Verified date May 2024
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of this study are to (1) identify the advance care planning deliberation process among 20 dyads of patients with advanced cancer and family caregivers and (2) conduct usability testing among 9 dyads to refine the content and design of the web-based resilience-building intervention.


Description:

Patients with advanced cancer have not fully benefited from advance care planning due to the high levels of anxiety and depression experienced and other barriers that affect their appraisals and coping. Despite the protective effects of resilience, there have been few clinical trials improving the resilience skills of patients with advanced cancer and their family caregivers to help initiate advance care planning discussions and sustain engagement. This research will provide new insights through using a dyadic intervention approach to advance care planning while developing and evaluating a web-based resilience-building intervention to improve the completion of advance directives, resilience, coping, anxiety, and depression for patients with advanced cancer and their family caregivers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date January 31, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients will be eligible for the study if they (1) are = 18 years of age; (2) have a stage 3 or 4 cancer diagnosis; (3) are able to read and respond to questions in English with minimal assistance from family caregivers for interpretation; (4) have previously completed an advance directive such as a living will; (5) have a family caregiver who serves as a surrogate in the advance directive and is willing to participate in the study; and (6) have access to the internet on a cell phone, laptop, or computer. - Family caregivers will be eligible if they (1) are = 18 years of age; (2) are able to read and respond to questions in English with minimal assistance from others for interpretation; (3) are identified by the patient as a family caregiver who serves as a surrogate for health care decisions; and (4) have access to the internet on a cell phone, laptop, or computer. Exclusion Criteria: - Patients who have cognitive impairment per a Short Portable Mental Status Questionnaire score < 8.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Web-based resilience-building intervention
There are 6 modules on the website. Participants will be encouraged to verbalize their impressions of the website prototype.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute of Nursing Research (NINR)

Outcome

Type Measure Description Time frame Safety issue
Primary Usability Qualitative feedback from participants about the impressions of the website prototype Immediately at the end of the usability testing
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