Psychological Screening and Support for Patients Enrolled in Early‐Phase Cancer Clinical Trials and the Possible Barriers: A Real‐World Tertiary Center Implementation Study

INTRODUCTION: One in three patients with cancer suffers from clinically significant depression and/or anxiety. Early-phase cancer clinical trials (EPCCTs) frequently include patients with advanced disease with limited treatment options. However, screening for psychological symptoms is not routinely performed in this setting. Here, we describe a mixed-methods implementation study exploring the feasibility of improving access to psychological screening in EPCCTs and assessing how electronic patient-reported outcome measures (ePROMs) can be utilized to identify those requiring intervention. METHODS: Perceived benefits and challenges associated with psychological screening in EPCCTs were explored from the clinician, psycho-oncology team, and patient and carer's perspectives, via clinician surveys and a patient and carer focus group. A standard workflow was created to enable routine psychological screening, alongside a stepped-care model for providing support. An ePROM, consisting of PHQ-2 and GAD-7 questionnaires, was distributed to patients enrolling on EPCCTs. RESULTS: Of the 17 clinicians who responded, 88% felt that routine psychological assessments were important, and 100% were willing to complete assessments with patients. Perceived barriers were identified relating to 4 main themes: resources, support services, training and staff misconceptions. Invitations to ePROMs were sent to 92 patients over 12 months and 59 (64.1%) have responded at baseline; of these, 13 (22.0%) patients have received intervention based on PHQ-2/GAD-7 score. Initial challenges associated with ePROM completion related to technological difficulties, missed notifications and form expiration. CONCLUSION: Our findings suggest that routine psychological assessments in EPCCTs may help identify previously undiagnosed psychological burden in patients, and facilitate their access to appropriate, timely support. This implementation study indicates this approach can be feasibly delivered through the use of ePROMs.