Resilience, PsychologicalNCT06061965
Facilitating Advance Care Planning Discussions for People With Advanced Cancer
A study testing Web-based resilience-building intervention in people with Resilience, Psychological and Advance Care Planning, run by University of Illinois Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resilience, Psychological, Advance Care Planning
- What is being tested?
- Web-based resilience-building intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for the study if they (1) are ≥ 18 years of age; (2) have a 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.
Who cannot join
- Patients who have cognitive impairment per a Short Portable Mental Status Questionnaire score < 8.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60607
About this study
Official title: Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention
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.
Read the 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.
- Conditions
- Resilience, Psychological, Advance Care Planning
- Being tested
- Web-based resilience-building intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based resilience-building interventionBehavioural
There are 6 modules on the website. Participants will be encouraged to verbalize their impressions of the website prototype.
| Study group | Role | What they receive |
|---|---|---|
| Web-based resilience-building | Experimental | 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. Receives: Behavioral: Web-based resilience-building intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Quantitative feedback from participants about the impressions of the website prototype. The System Usability Scale was used to measure the usability of the intervention among participants in the Aim 2 study. The instrument is rated on a scale of 1 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 100. A score of 68 or above will be used as a cut-off to assess participants' perceptions of their interactions with the intervention. Higher scores represent greater usability.
Measured: Immediately at the end of the usability testing on the day of the one-time interview
Secondary outcomes (1)
Acceptability
Participants' quantitative feedback on the acceptability of the website prototype. The Acceptability E-Scale was used to measure the acceptability of the intervention among participants in the Aim 2 study. The instrument is rated on a scale of 1 to 5, with a total score ranging from 6 to 30 and higher scores indicating higher degrees of acceptability. A score of 24 or above will be used as a cut-off to assess the acceptability of the intervention. Higher scores indicate greater acceptability.
Measured: Immediately at the end of the usability testing, on the day of the one-time interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start9 Jul 2024
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061965
- Sponsor's protocol ID
- 2023-0430
- Other IDs
- K99NR020358-01A1
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2023
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Advance Care Planning Discussions Between Patients With Advanced Cancer and Their Family Caregivers Using a Resilience-Building Intervention
- ClinicalTrials.gov ID
- NCT06061965
- Acronym / sponsor ID
- 2023-0430
- Conditions
- Resilience, Psychological, Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based resilience-building | Experimental | Behavioral: Web-based resilience-building interventionThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients will be eligible for the study if they (1) are ≥ 18 years of age; (2) have a 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.
Key exclusion criteria (1 listed)
- Patients who have cognitive impairment per a Short Portable Mental Status Questionnaire score < 8.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based resilience-building interventionThere are 6 modules on the website. Participants will be encouraged to verbalize their impressions of the website prototype. | Behavioural | Web-based resilience-building |
Primary outcome
Usability
Time frame: Immediately at the end of the usability testing on the day of the one-time interview
Quantitative feedback from participants about the impressions of the website prototype. The System Usability Scale was used to measure the usability of the intervention among participants in the Aim 2 study. The instrument is rated on a scale of 1 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 100. A score of 68 or above will be used as a cut-off to assess participants' perceptions of their interactions with the intervention. Higher scores represent greater usability.
1 secondary outcome
Acceptability
Time frame: Immediately at the end of the usability testing, on the day of the one-time interview
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based resilience-building intervention in people with Resilience, Psychological and Advance Care Planning, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: Immediately at the end of the usability testing on the day of the one-time interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.