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.