A Randomized Trial of Acceptability and Effects of Values-Based Advance Care Planning in Outpatient Oncology: Person-Centered Oncologic Care and Choices.

CONTEXT: No standard advance care planning (ACP) process exists in oncology. We previously developed and validated the values questions for Person-Centered Oncologic Care and Choices (P-COCC), a novel ACP intervention combining a patient values interview with an informational care goals video.
OBJECTIVES: To pilot-study acceptability and, using randomization, explore potential utility of P-COCC.
METHODS: Eligibility included patients with advanced gastrointestinal cancer cared for at a comprehensive cancer center. Participants were randomized 2:2:1 to P-COCC vs. video alone vs. usual care, respectively. Validated assessments of well-being and decisional conflict were completed. Participants in the P-COCC arm also completed three Likert scales (was the intervention helpful, comfortable, and recommended to others); a positive score of at least 1 of 3 indicated acceptability.
RESULTS: Patients were screened from 9/2014 to 11/2016; 151 were consented and randomized, 99 whom completed study measures (most common attrition reason: disease progression or death). The primary aim was met: Among 33 participants, P-COCC was acceptable to 32 (97%, 95% CI: 0.84-0.99, P < 0.001). Mean distress scores (0-10) increased (0.43) in the P-COCC arm but decreased in the video-alone (-0.04) and usual-care (-0.21) arms (P = 0.03 and 0.04, P-COCC vs. video-alone and usual-care arms, respectively). There were no significant pre-post change scores on other measures of well-being (e.g., anxiety, depression, stress) or intergroup differences in decisional conflict.
CONCLUSION: Our values-based ACP paradigm is acceptable but may increase distress in cancer outpatients. Further studies are investigating the underpinnings of these effects and ways to best support cancer patients in ACP.

RCT Entities:   Population Interventions Outcomes