A Phase II randomized trial to evaluate the feasibility, acceptability and potential effectiveness of a brief psychosocial intervention in combination with early palliative care in reducing depressive symptoms of patients with advanced cancers

• Grant number: 14/22052-5
• Support type: Regular Research Grants
• Duration: March 01, 2015 - February 28, 2017
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal researcher: Carlos Eduardo Paiva
• Grantee: Carlos Eduardo Paiva
• Home Institution: Hospital do Câncer de Barretos. Fundação Pio XII (FP). Barretos , SP, Brazil

Abstract

Patients with advanced cancer report physical, emotional, social and existential problems that may be due to the cancer itself or its treatment. Previous studies have demonstrated the benefit of early inclusion of palliative care (PC) in combination with standard oncologic care in reducing depressive symptoms, improving quality of life, increasing survival and also decreasing unnecessary invasive procedures. However, patients continue to arrive late at PC, even in large comprehensive cancer centers. One of the barriers is the stigma of PC perceived by patients and health professionals as "a place to die." The primaries objectives are to evaluate the feasibility and acceptance / satisfaction of patients with advanced cancer submitted to a brief psychosocial intervention based on Cognitive Behavioral Therapy (CBT) in addition to early PC and to evaluate the impact of these interventions on the reduction of depressive symptoms. A randomized, open-label, phase II trial, with two intervention arms and a control group. It will be included 150 patients with advanced cancer initiating palliative chemotherapy who meet the selection criteria. Participants will be recruited from the outpatient oncology clinics from the Barretos Cancer Hospital and will be randomized (1:1:1) in one of the three treatment arms: arm A, five weekly sessions of brief psychosocial interventions based on CBT in combination with early PC; arm B, early PC only; arm C, standard oncologic care. The HADS, PHQ-9, ESAS-br, FAMCARE-Patient scale, and the Disease Understanding Protocol, will be the instruments used for data collection. Patients will answer these instruments at baseline and after 45, 90, 120 and 180 days after randomization. An interim analysis is planned to occur after the inclusion of 20 participants with complete data in each arm; if the Cohen's effect size between the arms A and B is small (d<<0.2), the study will continue only with arms B and C. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

DO CARMO, THAMIRES MONTEIRO; RIBEIRO PAIVA, BIANCA SAKAMOTO; DE OLIVEIRA, CLEYTON ZANARDO; DE ANGELIS NASCIMENTO, MARIA SALETE; PAIVA, CARLOS EDUARDO. The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial. BMC CANCER, v. 17, AUG 23 2017. Web of Science Citations: 3.

DO CARMO, THAMIRES MONTEIRO; RIBEIRO PAIVA, BIANCA SAKAMOTO; DE SIQUEIRA, MILENA RUAS; BERNARDES DA ROSA, LUCIANA DE TOLEDO; DE OLIVEIRA, CLEYTON ZANARDO; DE ANGELIS NASCIMENTO, MARIA SALETE; PAIVA, CARLOS EDUARDO. A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial. Trials, v. 16, APR 12 2015. Web of Science Citations: 4.