NeoplasmsPREPArENCT02133274
A Psychosocial Intervention Plus Early Palliative Care in the Reduction of Depression of Advanced Cancer Patients
A study testing Brief Psychosocial Intervention and Early Palliative Care in people with Neoplasms, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Brief Psychosocial Intervention and Early Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neoplasms
- Being tested
- Brief Psychosocial Intervention, Early Palliative Care
- Keywords
- Neoplasms, Early Palliative Care, Psychosocial Intervention, Symptoms, Quality of life, Depression
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Psychosocial InterventionBehavioural
Five weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy designed specifically for the present study.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Psychosocial Intervention; Other: Early Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90.
Measured: 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.
Measured: Baseline, Days 45, 90, 120 and 180.
Descriptive results about feasibility of the study.
Measured: 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.
Measured: Baseline, Days 45, 120, 180.
Change from baseline in anxiety symptoms on the HADS-A at days 45,90, 120 and 180.
Measured: 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.
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.
Measured: At 90, 120 and 180 days.
Change from baseline in cancer symptoms on the ESAS at days 45,90, 120 and 180.
Measured: 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.
Measured: Baseline, Days 45, 90, 120, 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2016
- Study completionFeb 2017
Why it stopped: Planned interim analysis did not show the expected benefit of intervention A over B (effect size \<0.2).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Eduardo Paiva, Barretos Cancer Hospital
- Investigators
- Carlos E Paiva, MD, PHD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133274
- Sponsor's protocol ID
- GPQual-001
- Acronym
- PREPArE
- Status last verified
- Feb 2017
- First submitted
- 6 May 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28836960do 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.
PubMed 25872950
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02133274
- Acronym / sponsor ID
- PREPArE / GPQual-001
- Conditions
- Neoplasms
- Keywords
- Neoplasms, Early Palliative Care, Psychosocial Intervention, Symptoms, Quality of life, Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Planned interim analysis did not show the expected benefit of intervention A over B (effect size \<0.2).
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard oncologic care | No intervention | –Standard oncologic care |
| Early Palliative Care | Experimental | Other: Early Palliative CareA 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. |
| Psychosocial plus early Palliative Care | Experimental | Behavioral: Brief Psychosocial Intervention, Other: Early Palliative CareFive 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Psychosocial InterventionFive weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy designed specifically for the present study. | Behavioural | Psychosocial plus early Palliative Care |
| Early Palliative CareEarly 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. | Other | Early Palliative Care, Psychosocial plus early Palliative Care |
Primary outcome
Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90.
Time frame: Baseline, Day 90.
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.
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.
5 secondary outcomes
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.
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.
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.
Change from baseline in cancer symptoms on the ESAS at days 45,90, 120 and 180.
Time frame: 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.
Time frame: Baseline, Days 45, 90, 120, 180.
Results and safety
The study was stopped early (reason given: Planned interim analysis did not show the expected benefit of intervention A over B (effect size \<0.2).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 28836960do 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.
- Derived from this study: PubMed 25872950do 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos E Paiva, MD, PHD principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Psychosocial Intervention and Early Palliative Care in people with Neoplasms, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Planned interim analysis did not show the expected benefit of intervention A over B (effect size \<0.2).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in depression symptoms on the HADS-D and PHQ-9 at day 90. (time frame: Baseline, Day 90.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133274, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.