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Trial record 1 of 1 for:    NCT02133274
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A Psychosocial Intervention Plus Early Palliative Care in the Reduction of Depression of Advanced Cancer Patients (PREPArE)

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ClinicalTrials.gov Identifier: NCT02133274
Recruitment Status : Terminated (Planned interim analysis did not show the expected benefit of intervention A over B (effect size <0.2).)
First Posted : May 8, 2014
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Eduardo Paiva, Barretos Cancer Hospital

Brief Summary:
The purpose of this study is to determine whether a brief psychosocial intervention together with early palliative care are feasible, acceptable and effective in the reduction of depressive symptoms of patients with advanced cancers starting first line palliative chemotherapy.

Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Brief Psychosocial Intervention Other: Early Palliative Care Not Applicable

Detailed Description:
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 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 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 Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9 (PHQ-9), Brazilian version of the Edmonton Symptom Assessment System (ESAS-br), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 PAL (EORTC QLQ-C15-Pal), 13-item measure of patient satisfaction (FAMCARE-P13), 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Phase II Randomized Controlled Trial to Evaluate a Brief Psychosocial Intervention Together With Early Palliative Care in Reducing Depressive Symptoms of Patients With Advanced Cancer Starting First Line Palliative Chemotherapy
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
No Intervention: Standard oncologic care
Standard oncologic care
Experimental: Early Palliative Care
A first medical consult at the Palliative Care Service will be scheduled after 2 to 3 weeks from the study inclusion and every 3 to 4 weeks thereafter.
Other: Early Palliative Care
Early integration of Palliative Care into the standard oncologic care. Patients starting first line chemotherapy will receive immediately evaluation by the board-certified palliative care physicians.

Experimental: Psychosocial plus early Palliative Care
Five weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy plus early palliative care. Regarding the early Palliative Care, a first medical consult at the Palliative Care Service will be scheduled after 2 to 3 weeks from the study inclusion and every 3 to 4 weeks thereafter.
Behavioral: Brief Psychosocial Intervention
Five weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy designed specifically for the present study.

Other: Early Palliative Care
Early integration of Palliative Care into the standard oncologic care. Patients starting first line chemotherapy will receive immediately evaluation by the board-certified palliative care physicians.




Primary Outcome Measures :
  1. Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90. [ Time Frame: Baseline, Day 90. ]
  2. Change from baseline in satisfaction with care on the FAMCARE-patient scale at days Days 45, 90, 120 and 180. [ Time Frame: Baseline, Days 45, 90, 120 and 180. ]
    Evaluation of the satisfaction perceived by the patients regarding health care.

  3. Descriptive results about feasibility of the study. [ Time Frame: Average duration in minutes of each intervention session (both regarding Palliative Care consultation and Psychological session); number of non-attendance to the interventions (absences); reasons reported by patients for missing. ]

Secondary Outcome Measures :
  1. Change from baseline in depressive symptoms on the HADS-D and PHQ-9 at days 45,120 and 180. [ Time Frame: Baseline, Days 45, 120, 180. ]
  2. Change from baseline in anxiety symptoms on the HADS-A at days 45,90, 120 and 180. [ Time Frame: Baseline, Days 45, 90, 120, 180. ]
  3. Proportion of patients answering that their cancer is curable as measured using an adapted instrument to evaluate Cancer Understanding. [ Time Frame: At 90, 120 and 180 days. ]
    Considering that all patients included will have incurable advanced cancers, those answering that their disease is curable will be interpreted as not adequately aware of their prognosis.

  4. Change from baseline in cancer symptoms on the ESAS at days 45,90, 120 and 180. [ Time Frame: Baseline, Days 45, 90, 120, 180. ]
  5. Change from baseline in quality of life on the EORTC QLQ-C15-Pal at days 45,90, 120 and 180. [ Time Frame: Baseline, Days 45, 90, 120, 180. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and <75 years;
  • Adequate knowledge about the cancer diagnosis;
  • Starting first line palliative antineoplastic treatment;
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤ 2;
  • Life expectancy> 6 months and <24 months (as per the medical oncologist);
  • Must have on the following diagnoses:

Metastatic or unresectable recurrent breast cancer; Stage IIIC or IV recurrent platinum-resistant ovarian cancer; Metastatic or unresectable recurrent cervix cancer; Metastatic or unresectable recurrent endometrial cancer; Metastatic or unresectable recurrent head and neck cancer (after previous radiotherapy); Hormone-refractory metastatic or unresectable recurrent prostate cancer; Metastatic or unresectable recurrent genitourinary cancer; Metastatic or unresectable recurrent non-small cell lung cancer; Extensive-stage or recurrent small cell lung cancer; Metastatic or unresectable recurrent gastrointestinal cancer;

Exclusion Criteria:

  • Currently undergoing any psychological treatment due to a psychological disorder;
  • Currently using antidepressants to treat depressive disorders and / or anxiety;
  • Any cognitive deficit or attention problem that could interfere in the ability to answer questionnaires or understand the study aims (as per investigator);
  • Current or previous established diagnosis of any of the following psychological conditions: Substance-Related Disorders; Schizophrenia and Other Psychotic Disorders; Mood Disorders (Depressive Disorders, Bipolar Disorders); Anxiety Disorders; Dissociative Disorders; Personality Disorders; and / or a history of suicide attempt;
  • Patients with single resected metastasis;
  • Any co-morbid condition, which, in the opinion of the investigator, could interfere with the safety, the compliance with the study or with the interpretation of the results.
  • Patients unable to go to the hospital for the study visits, regardless of the reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133274


Locations
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Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784-400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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Principal Investigator: Carlos E Paiva, MD, PHD Barretos Cancer Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carlos Eduardo Paiva, MD, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02133274    
Other Study ID Numbers: GPQual-001
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Keywords provided by Carlos Eduardo Paiva, Barretos Cancer Hospital:
Neoplasms
Early Palliative Care
Psychosocial Intervention
Symptoms
Quality of life
Depression
Additional relevant MeSH terms:
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Neoplasms