Resilience-Building for Advance Care Planning

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Illinois at Chicago

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ROCKS

    Behavioral

    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.

  • Usual Care

    Behavioral

    An advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: ROCKSExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Completion of advance directives

Completion of Five Wishes

Time frame
Week 8

Secondary outcomes

1

Resilience

Assessed using the Connor-Davidson Resilience Scale (Range: 0-100; higher scores indicate a greater level of resilience)

Time frame
Week 8
2

Optimism

Assessed using the Revised Compound Psychological Capital Scale (Range: 3-18; higher scores indicate a greater level of optimism)

Time frame
Week 8
3

Dyadic communication and coping

Assessed using the Dyadic Coping Inventory (Range: 35-175; higher scores indicate greater perceived communication and dyadic coping)

Time frame
Week 8
4

Knowledge

Assessed using the Advance Care Planning Engagement Survey (Range: 2-10; Higher scores indicate a greater knowledge of advance care planning)

Time frame
Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator