title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial was registered on 6 May 2014 with ClinicalTrials.gov (identifier: NCT02133274).
authors: Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. thamires.ipc@gmail.com.
authors: Thamires Monteiro
authors: TM
authors: do Carmo
authors: Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. bsrpaiva@gmail.com.|Center for Research Support - NAP, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. bsrpaiva@gmail.com.
authors: Bianca Sakamoto Ribeiro
authors: BS
authors: Paiva
authors: Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. miruas@uol.com.br.
authors: Milena Ruas
authors: MR
authors: de Siqueira
authors: Human Sciences Institute - Psychologist Course, Universidade Paulista (UNIP), São José do Rio Preto, São Paulo, Brazil. lutbrosa@terra.com.br.
authors: Luciana de Toledo Bernardes
authors: Lde T
authors: da Rosa
authors: Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. bioestatistica@hcancerbarretos.com.br.|Center for Research Support - NAP, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. bioestatistica@hcancerbarretos.com.br.
authors: Cleyton Zanardo
authors: CZ
authors: de Oliveira
authors: Palliative Care Department, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. saletenascimento@uol.com.br.
authors: Maria Salete de Angelis
authors: MS
authors: Nascimento
authors: Palliative Care and Health-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. caredupai@gmail.com.|Center for Research Support - NAP, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. caredupai@gmail.com.|Palliative Care Department, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. caredupai@gmail.com.|Department of Clinical Oncology, Barretos Cancer Hospital, Pio XII Foundation, Barretos, São Paulo, Brazil. caredupai@gmail.com.|Departamento de Oncologia Clínica, Divisão de Mama e Ginecologia, Rua Antenor Duarte Vilella, Bairro Dr Paulo Prata, 1331, Barretos, SP, Brazil. caredupai@gmail.com.
authors: Carlos Eduardo
authors: CE
authors: Paiva
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D000368:Aged; D001938:Brazil; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000473:pathology / Q000523:psychology / Q000628:therapy*; D010166:Palliative Care / Q000379:methods*; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D011788:Quality of Life; D012017:Referral and Consultation; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D000069341:Transitional Care; D016896:Treatment Outcome; D055815:Young Adult