Clinical trial · Interventional
A Psychosocial Intervention Plus Early Palliative Care in the Reduction of Depression of Advanced Cancer Patients
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
NCT02133274CI-TRIAL-00025962PREPArEterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planned interim analysis did not show the expected benefit of intervention A over B (effect size \<0.2).
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief Psychosocial Intervention | Behavioral | — | UNRESOLVED |
| Early Palliative Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Standard oncologic care
- description
- Standard oncologic care
- type
- EXPERIMENTAL
- label
- Early Palliative Care
- description
- 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.
- interventionNames
- Other: Early Palliative Care
- type
- EXPERIMENTAL
- label
- Psychosocial plus early Palliative Care
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDdo 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 28836960
- DERIVEDdo 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 25872950