Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer

Traumatic stress symptoms are measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a validated 30-item self-report instrument specifically designed to assess traumatic stress symptoms based on DSM-5 criteria. The SASRQ-II provides a total score range of 0-150, where higher scores reflect increasing symptom severity and cut-off scores of >40 indicate clinically significant traumatic stress symptoms.

Attachment security is measured by the ECR-M-16, a validated 16-item measure adapted to measure close relationships in patients with advanced cancer. Two 8-item subscales are derived from this measure, reflecting levels of anxious attachment and avoidant attachment, which can be helpful to understand and address attachment issues in patients with advanced cancer. Items are rated from 1 (agree) to 7 (disagree), with higher scores reflecting greater attachment insecurity.

Physical symptoms commonly experienced by cancer patients are measured by the Condensed Memorial Symptom Assessment Scale (CMSAS), a validated 14-item instrument that assesses distress related to symptoms including pain, fatigue, nausea, and drowsiness. Serves as an important covariate to control for physical symptom burden that may influence psychological outcomes. Symptoms are rated as present or not, with the level of distress associated with physical symptoms rated from 0 (not at all) to 4 (very much), and the frequency of psychological symptoms (worry, feeling sad, feeling nervous) rated 1 (rarely) to 4 (almost constantly). Higher scores reflect increasing symptom burden.

Depression severity is measured by the Patient Health Questionnaire (PHQ-9), a validated 9-item instrument assessing depression severity that has demonstrated reliability and validity in cancer populations. Scores may range from 0-27, with higher scores reflecting increasing severity of depressive symptoms. A cut-off score of 10 is used to reflect moderate depressive symptoms.

Distress related to thoughts on death and dying are measured by the Death and Dying Distress Scale (DADDS), a validated 15-item questionnaire evaluating distress caused by a patient's thoughts on death and dying. Factor analysis demonstrates distress related to two factors: Finitude and Dying. Total scores may range from 0-75, with higher scores indicating greater death-related distress.

Health-related quality of life is measured by the EQ-5D-5L Health Questionnaire, a validated instrument that measures quality of life across five dimensions (mobility, self-care, activities, pain, and anxiety) using a 5-level scale. It provides both a health state profile and a single utility index value. Dimension scores are rated from 1 (no problems) to 5 (extreme problems), with higher scores reflecting worse health status. The single utility index score is rated from 0 (worst imaginable health) to 100 (best imaginable health).

Health-related quality of life is measured by the SF-6D Health Survey, derived from the Short Form-36 health questionnaire. It evaluates six health dimensions (physical functioning, role limitations, social functioning, pain, mental health, and vitality), each rated from 0 (worst health state, e.g. death) to 1.0 (best health state, e.g., full health). This measure also allows for the calculation of quality adjusted life years (QALYs), which can be used to evaluate cost-effectiveness of health care interventions.

Perceived benefit of interactions with healthcare providers are measured by the Clinical Evaluation Questionnaire (CEQ), a validated 7-item patient-reported experience questionnaire that assesses perceived benefit in domains relevant to advanced cancer, including patient-provider communication and perceived quality of care. Items are rated on perceived helpfulness of the interactions, ranging from 0 (not at all) to 4 (very much), with an option to answer 'not applicable'. A total score is calculated by summing the item scores; 'not applicable' responses are considered missing data. Higher scores reflect greater perceived benefit of the interactions with healthcare providers.