- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07428278
Resilience-Building for Advance Care Planning (ROCKS)
February 16, 2026 updated by: University of Illinois at Chicago
Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention: A Randomized Controlled Trial.
The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 evaluates the impact of a web-based resilience-building intervention called ROCKS on enhancing the completion of advance directives, as well as improving resilience, coping, anxiety, and depression among patients with advanced cancer and their family caregivers.
Study Type
Interventional
Enrollment (Estimated)
152
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li-Ting Longcoy
- Phone Number: 312-996-3024
- Email: liting@uic.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.
- Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.
Exclusion Criteria:
- Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score < 8; or (2) have completed any form of advance directive.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ROCKS
Participants assigned to this arm will receive a web-based resilience-building intervention.
|
The intervention will be provided to participants to strengthen optimism, communication skills, knowledge, and self-efficacy to support patients and family caregivers in engaging in advance care planning discussions.
|
|
Active Comparator: Usual Care
Participants assigned to this arm will receive an advance directive called Five Wishes.
|
An advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of advance directives
Time Frame: Week 8
|
Completion of Five Wishes
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: Week 8
|
Assessed using the Connor-Davidson Resilience Scale
|
Week 8
|
|
Optimism
Time Frame: Week 8
|
Assessed using the Revised Compound PsyCap Scale
|
Week 8
|
|
Dyadic communication and coping
Time Frame: Week 8
|
Assessed using the Dyadic Coping Inventory
|
Week 8
|
|
Knowledge
Time Frame: Week 8
|
Assessed using the Advance Care Planning Engagement Survey
|
Week 8
|
|
Self-efficacy
Time Frame: Week 8
|
Assessed using the Advance Care Planning Engagement Survey
|
Week 8
|
|
Anxiety
Time Frame: Week 8
|
Assessed using the Generalized Anxiety Disorder-7
|
Week 8
|
|
Depression
Time Frame: Week 8
|
Assessed using the Patient Health Questionnaire-9
|
Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 20, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
July 31, 2028
Study Registration Dates
First Submitted
February 16, 2026
First Submitted That Met QC Criteria
February 16, 2026
First Posted (Actual)
February 23, 2026
Study Record Updates
Last Update Posted (Actual)
February 23, 2026
Last Update Submitted That Met QC Criteria
February 16, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0430: Aim 4-6
- R00NR020358 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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