NCT02133274

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

May 6, 2014

Last Update Submit

February 12, 2017

Conditions

Neoplasms

Keywords

NeoplasmsEarly Palliative CarePsychosocial InterventionSymptomsQuality of lifeDepression

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90.

    Baseline, Day 90.

  • Change from baseline in satisfaction with care on the FAMCARE-patient scale at days Days 45, 90, 120 and 180.

    Evaluation of the satisfaction perceived by the patients regarding health care.

    Baseline, Days 45, 90, 120 and 180.

  • Descriptive results about feasibility of the study.

    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 Outcomes (5)

  • Change from baseline in depressive symptoms on the HADS-D and PHQ-9 at days 45,120 and 180.

    Baseline, Days 45, 120, 180.

  • Change from baseline in anxiety symptoms on the HADS-A at days 45,90, 120 and 180.

    Baseline, Days 45, 90, 120, 180.

  • Proportion of patients answering that their cancer is curable as measured using an adapted instrument to evaluate Cancer Understanding.

    At 90, 120 and 180 days.

  • Change from baseline in cancer symptoms on the ESAS at days 45,90, 120 and 180.

    Baseline, Days 45, 90, 120, 180.

  • Change from baseline in quality of life on the EORTC QLQ-C15-Pal at days 45,90, 120 and 180.

    Baseline, Days 45, 90, 120, 180.

Study Arms (3)

Standard oncologic care

NO INTERVENTION

Standard oncologic care

Early Palliative Care

EXPERIMENTAL

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

Psychosocial plus early Palliative Care

EXPERIMENTAL

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 InterventionOther: Early Palliative Care

Interventions

Brief Psychosocial InterventionBEHAVIORAL

Five weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy designed specifically for the present study.

Psychosocial plus early Palliative Care
Early Palliative CareOTHER

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.

Early Palliative CarePsychosocial plus early Palliative Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784-400, Brazil

Location

Related Publications (2)

  • do Carmo TM, Paiva BSR, de Oliveira CZ, Nascimento MSA, Paiva CE. 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. 2017 Aug 23;17(1):564. doi: 10.1186/s12885-017-3560-6.

    PMID: 28836960DERIVED

  • do Carmo TM, Paiva BS, de Siqueira MR, da Rosa Lde T, de Oliveira CZ, Nascimento MS, Paiva CE. 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. 2015 Apr 12;16:160. doi: 10.1186/s13063-015-0655-8.

    PMID: 25872950DERIVED

MeSH Terms

Conditions

NeoplasmsDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Carlos E Paiva, MD, PHD

    Barretos Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

BR(1)