None listed
Conditions
Brief summary
The overall aim of this study is to assess the acceptability, feasibility and potential impact of CALM in people with advanced NSCLC treated with novel therapies. The specific objectives of this project are to: Assess the feasibility of the CALM intervention, outcome measures, and study design to guide the development of a Phase 3 RCT; Explore the acceptability of CALM to patients with advanced NSCLC treated with novel therapies and to CALM therapists; Provide preliminary evaluation of the potential impact of CALM in this population. Study Design: A mixed methods design will be used for this pilot study.
Interventions
CALM is a semi-structured, manualized, individual psychotherapy designed for patients with advanced cancer and their loved ones. It shares features with manualized supportive-expressive, cognitive-existential, and meaning-centered group psychotherapies applied to patients with advanced and terminal disease. It was developed based on empirical data, clinical observations, and the theoretical foundations of relational, attachment and existential theory. It is informed by the founding team’s Canadian Institute of Health Research (CIHR)-funded longitudinal research aimed at identifying the antecedents and course of psychosocial morbidity in individuals with metastatic cancer. CALM includes 3-6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3-6 months. Session frequency is according to participant preference and participant / therapist availability. Additional sessions may be offered if clinically indicated. The sessions cover 4 domains: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) sense of meaning and purpose; and 4) the future and mortality. All modules will be addressed with each patient, but the sequencing and time devoted to each domain will vary, based on the concerns that are most relevant to each patient. The patient’s caregiver (e.g., spouse, adult son/daughter, family member), or other persons accompanying the patient are encouraged to participate in one or more of the therapy sessions, as deemed appropriate by the patient and therapist. CALM can be delivered by specially trained therapists from a wide range of disciplines, including social work, nursing, psychiatry, psychology, and medicine. CALM will be delivered in person, via telehealth (video-call), or phone call if no alternative is available. CALM therapists have been previously specifically trained in CALM completing a minimum of two days of CALM training unrelated to this study available to any practitioner delivered in person by CALM psychiatry developers Prof Gary Rodin and Prof Sarah Hales of Princess Margaret Cancer Centre. Therapists had also regularly attended CALM group supervision with Prof Rodin via video call at approximately monthly intervals. Therapists will include two clinical psychologists and one clinical nurse consultants. The patient’s CALM therapists will be provided with a copy of their measures completed at each timepoint whilst the therapist is still treating the patient including Patient Health Questionnaire (PHQ-9), Death and Dying Distress Scale (DADDS) and Functional Assessment of Cancer Therapy General (FACT-G). These are provided to inform clinical treatment and for therapists to discuss with patient as applicable. Therapists will present each case a minimum of one occasion at supervision with Professor Gary Rodin, and optimally at the start and end of therapy, during which they will present a small segment of audio recording of a therapy session where available. Treatment fidelity will be assessed by 1) a review of supervisor-rated treatment fidelity using the CALM Treatment Integrity Measure (CTIM) completed after each supervisory session, 2) audio recording all sessions and then reviewing sections of therapy sessions during supervision to check compliance with protocols using the CTIM.
Sponsors
Study design
Eligibility
Inclusion criteria
at least 18 years old; diagnosis of locally advanced NSCLC or metastatic NSCLC; currently or previously receiving immunotherapy or targeted therapy and at least 6 months post initiation of IT (such as pembrolizumab, atezolizumab, nivolumab) or TT (such as TT directed at EGFR, ALK, ROS1, BRAF, MEK or RET) or combination chemotherapy/immunotherapy; expected prognosis of at least 6 months (to allow for completion of therapy); able to read and write in English. able to commit to 3-6 sessions.
Exclusion criteria
major communication difficulties; cognitive impairment on the basis of a Short Orientation-Memory-Concentration Test (SOMCT) of 7 or more or indicated by the clinical team or medical file patients currently receiving formal psychological therapy.