Facilitating Advance Care Planning Discussions for People With Advance Cancer

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06061965
Collaborator
National Institute of Nursing Research (NINR) (NIH)
18
1
10

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web-based resilience-building intervention
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Web-based resilience-building

The web-based resilience-building intervention will be implemented on a website and consist of (1) assessments to help participants (a) understand their coping strategies and (b) appraise their beliefs, values, and goals about advance care planning and (2) 6 weekly modules.

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.

Outcome Measures

Primary Outcome Measures

  1. Usability [Immediately at the end of the usability testing]

    Qualitative feedback from participants about the impressions of the website prototype

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Illinois at Chicago
  • National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT06061965
Other Study ID Numbers:
  • 2023-0430
  • K99NR020358-01A1
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 29, 2023