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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
ROCKS
BehavioralThe 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
BehavioralAn advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.
Treatment groups
Trial outcomes
Primary outcomes
Completion of advance directives
Completion of Five Wishes
Secondary outcomes
Resilience
Assessed using the Connor-Davidson Resilience Scale (Range: 0-100; higher scores indicate a greater level of resilience)
Optimism
Assessed using the Revised Compound Psychological Capital Scale (Range: 3-18; higher scores indicate a greater level of optimism)
Dyadic communication and coping
Assessed using the Dyadic Coping Inventory (Range: 35-175; higher scores indicate greater perceived communication and dyadic coping)
Knowledge
Assessed using the Advance Care Planning Engagement Survey (Range: 2-10; Higher scores indicate a greater knowledge of advance care planning)
Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator