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

Author(s)

do Carmo, Thamires Monteiro ^[1] ; Ribeiro Paiva, Bianca Sakamoto ^{[1, 2]} ; de Siqueira, Milena Ruas ^[1] ; Bernardes da Rosa, Luciana de Toledo ^[3] ; de Oliveira, Cleyton Zanardo ^{[1, 2]} ; de Angelis Nascimento, Maria Salete ^[4] ; Paiva, Carlos Eduardo ^{[1, 2, 4, 5, 6]}

Affiliation

^[1] Pio XII Fdn, Barretos Canc Hosp, Palliat Care & Hlth Related Qual Life Res Grp GPQ, Sao Paulo - Brazil

^[2] Pio XII Fdn, Barretos Canc Hosp, Ctr Res Support NAP, Sao Paulo - Brazil

^[3] Univ Paulista UNIP, Human Sci Inst Psychologist Course, Sao Paulo - Brazil

^[4] Pio XII Fdn, Barretos Canc Hosp, Palliat Care Dept, Sao Paulo - Brazil

^[5] Pio XII Fdn, Barretos Canc Hosp, Dept Clin Oncol, Sao Paulo - Brazil

^[6] Dept Clin Oncol, Div Mama & Ginecol, BR-1331 Barretos, SP - Brazil

• Document type: Journal article
• Source: Trials; v. 16, APR 12 2015.
• Web of Science Citations: 4

Abstract

Background: Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as `a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment. Methods/design: The primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization. Discussion: Despite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced cancer may benefit from a psychosocial and educational strategy that adequately prepares them for initial PC appointments after an early referral to PC. We anticipate that benefits of psychological intervention shall be synergistic to secondary emotional benefits from the early integration of PC. (AU)

• FAPESP's process: 14/22052-5 - 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
• Grantee: Carlos Eduardo Paiva
• Support Opportunities: Regular Research Grants