Evidence map›Paper›PMID 28836960›Full record

Trial reportBMC cancer2017

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.

Thamires Monteiro do Carmo, Bianca Sakamoto Ribeiro Paiva, Cleyton Zanardo de Oliveira, Maria Salete de Angelis Nascimento, Carlos Eduardo Paiva

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02133274 (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), which is not on this map. Cited by 19 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 7 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02133274 naterminatednot on this map

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

TypeinterventionalSponsorBarretos Cancer HospitalRan2014 to 2017Enrolled63ConditionsNeoplasmsArmsBrief Psychosocial Intervention, Early Palliative Care
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 7 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
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  6. Quality of life of cancer patients at palliative care units in developing countries: systematic review of the published literature.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
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  15. Models of Palliative Care Delivery for Patients With Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Thamires Monteiro do CarmoHealth-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos, SP, Brazil.
Bianca Sakamoto Ribeiro PaivaHealth-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos, SP, Brazil.
Cleyton Zanardo de OliveiraCenter for Research Support (NAP), Barretos Cancer Hospital, Barretos, SP, Brazil.
Maria Salete de Angelis NascimentoPalliative Care Department, Barretos Cancer Hospital, Barretos, SP, Brazil.
Carlos Eduardo PaivaHealth-Related Quality of Life Research Group (GPQual), Barretos Cancer Hospital, Barretos, SP, Brazil. caredupai@gmail.com.
Hospital de Câncer de Barretos · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer.

methodsAn open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization.

resultsFrom the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74).

conclusionsFuture studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression.

trial registrationClinical Trials identifier NCT02133274 . Registered May 6, 2014.

Indexed as

Psychiatric RehabilitationAdultAgedDepressionFemaleHumansMaleMiddle AgedNeoplasmsNeoplasm StagingOutcome Assessment, Health CarePalliative CarePilot ProjectsTime FactorsAnxietyCognitive therapyDepressionNeoplasmsPalliative care

Identifiers

PMID28836960
PMCPMC5569457
OpenAlexW2746649528

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.