DepressionNCT07168096
Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
An observational study of Depression and Cancer, run by Fundación Sociedad Española de Oncologia Médica at 18 sites in Spain.
Trial summary
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Cancer, Anxiety
- What is being tested?
- Psychosocial and clinical assessment
- How many people
- 540 participants
- Where
- 18 sitesSpain
- Study dates
- 12 Sep 2024to Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult oncology patients diagnosed with solid (non-hematologic) cancer at any stage, aged 18 years or older, who are candidates for perioperative systemic antineoplastic treatment or have advanced disease.
Who may be able to join
- Histologically confirmed diagnosis of solid cancer (non-hematologic) at any stage.
- Adult age (>18 years).
- Candidate for perioperative systemic antineoplastic treatment or for advanced disease.
- Willingness to participate in the study and sign the informed consent form, as appropriate, before initiating any study-specific procedures, in accordance with good clinical practice requirements and local regulations.
Who cannot join
- Presence of a pre-existing psychiatric or neurodegenerative disorder that impairs the patient's ability to participate in the study.
- Presence of reading and writing difficulties that prevent the patient from completing the assessments.
- Receipt of oncological treatment in the past 2 years for another cancer.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Spain18 sites, 18 recruiting
- Recruiting
Hospital General Universitario de Elche
Alicante, Elche, 03203
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario del Sureste
Arganda, Madrid, 28500
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, Ciudad Real, 13005
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Virgen de la Luz
Cuenca, Cuenca, 16002
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo, Madrid, 28046
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Fuenlabrada
Fuenlabrada, Madrid, 28942
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Complejo Hospitalario de Orense
Ourense, Orense, 32005
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de La Princesa
Salamanca, Madrid, 28006
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38320
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Infanta Leonor
Vallecas, Madrid, 28031
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
Dra. Paula Jiménez Fonseca, MD-PhD, 985106121 ext. 36582, palucaji@hotmail.com
About this study
Official title: NEOPSYCO STUDY: Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life, cognitive difficulties, fear of recurrence), and physical activity-and their association with support needs and utilization of psychosocial services.
Read the detailed description
The study population consists of consecutive oncology patients recruited across multiple centers, with data collection occurring at baseline (diagnosis or treatment initiation) and at 3-month and 6-month follow-up time points.
- Conditions
- Depression, Cancer, Anxiety
- Being tested
- Psychosocial and clinical assessment
- Keywords
- anxiety, cancer, depression, quality of life, cognitive difficulties
- Medical subject headings
- Depression, Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial and clinical assessmentOther
Participants complete standardized self-report questionnaires and undergo medical record review at three time points (baseline, 3 months, and 6 months) to assess psychological symptoms (anxiety, depression, somatization), coping strategies, quality of life, cognitive difficulties, physical activity, nutrition, supportive care needs, and informed decision-making in the context of cancer treatment. No experimental treatment or therapy is administered.
| Study group | Role | What they receive |
|---|---|---|
| Patients with baseline symptoms | Patients presenting symptoms of anxiety and/or depression at the time of study inclusion. These patients will be followed to evaluate the evolution of symptoms and the impact of clinical and psychosocial variables over time Receives: Other: Psychosocial and clinical assessment | |
| Patients without baseline symptoms | Patients without symptoms of anxiety or depression at the time of study inclusion. These participants serve as a comparison group to explore predictors of psychological distress trajectories and use of supportive care resources. Receives: Other: Psychosocial and clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression symptoms
The primary outcome of our study is psychological distress, specifically anxiety and depression symptoms, which will be measured using the Brief Symptom Inventory-18 (BSI-18).
BSI-18 provides a single outcome measure for distress. The scoring ranges are as follows: 0-66 (low risk of depression and/or anxiety), 67-71 (intermediate risk), and >71 (clinically significant distress).
Measured: At the time of diagnosis or treatment initiation. Follow-up at 3 months: To assess the early evolution of symptoms. Follow-up at 6 months: To analyze the medium-term evolution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start12 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fundación Sociedad Española de Oncologia Médica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Dra. Jiménez Fonseca, MD-PhD, Principal investigator, Sociedad Española de Oncología Médica (SEOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168096
- Sponsor's protocol ID
- SEOM-NEOpsico-2024-01
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOPSYCO STUDY: Trajectories of Anxiety and Depression in Cancer Patients, Risk and Predictive Factors and Supportive Care; Prognostic Awareness and Shared Decision Making.
- ClinicalTrials.gov ID
- NCT07168096
- Acronym / sponsor ID
- SEOM-NEOpsico-2024-01
- Conditions
- Depression, Cancer, Anxiety
- Keywords
- anxiety, cancer, depression, quality of life, cognitive difficulties
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fundación Sociedad Española de Oncologia MédicaUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- 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.
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life, cognitive difficulties, fear of recurrence), and physical activity-and their association with support needs and utilization of psychosocial services.
Detailed description
The study population consists of consecutive oncology patients recruited across multiple centers, with data collection occurring at baseline (diagnosis or treatment initiation) and at 3-month and 6-month follow-up time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with baseline symptoms | – | Other: Psychosocial and clinical assessmentPatients presenting symptoms of anxiety and/or depression at the time of study inclusion. These patients will be followed to evaluate the evolution of symptoms and the impact of clinical and psychosocial variables over time |
| Patients without baseline symptoms | – | Other: Psychosocial and clinical assessmentPatients without symptoms of anxiety or depression at the time of study inclusion. These participants serve as a comparison group to explore predictors of psychological distress trajectories and use of supportive care resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult oncology patients diagnosed with solid (non-hematologic) cancer at any stage, aged 18 years or older, who are candidates for perioperative systemic antineoplastic treatment or have advanced disease.
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of solid cancer (non-hematologic) at any stage.
- Adult age (>18 years).
- Candidate for perioperative systemic antineoplastic treatment or for advanced disease.
- Willingness to participate in the study and sign the informed consent form, as appropriate, before initiating any study-specific procedures, in accordance with good clinical practice requirements and local regulations.
Key exclusion criteria (3 listed)
- Presence of a pre-existing psychiatric or neurodegenerative disorder that impairs the patient's ability to participate in the study.
- Presence of reading and writing difficulties that prevent the patient from completing the assessments.
- Receipt of oncological treatment in the past 2 years for another cancer.
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 |
|---|---|---|
| Psychosocial and clinical assessmentParticipants complete standardized self-report questionnaires and undergo medical record review at three time points (baseline, 3 months, and 6 months) to assess psychological symptoms (anxiety, depression, somatization), coping strategies, quality of life, cognitive difficulties, physical activity, nutrition, supportive care needs, and informed decision-making in the context of cancer treatment. No experimental treatment or therapy is administered. | Other | Patients with baseline symptoms, Patients without baseline symptoms |
Primary outcome
Anxiety and depression symptoms
Time frame: At the time of diagnosis or treatment initiation. Follow-up at 3 months: To assess the early evolution of symptoms. Follow-up at 6 months: To analyze the medium-term evolution.
The primary outcome of our study is psychological distress, specifically anxiety and depression symptoms, which will be measured using the Brief Symptom Inventory-18 (BSI-18). BSI-18 provides a single outcome measure for distress. The scoring ranges are as follows: 0-66 (low risk of depression and/or anxiety), 67-71 (intermediate risk), and >71 (clinically significant distress).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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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.
Paula Dra. Jiménez Fonseca, MD-PhD principal investigator
Sociedad Española de Oncología Médica (SEOM)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Cancer, run by Fundación Sociedad Española de Oncologia Médica at 18 sites in Spain.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paula Dra. Jiménez Fonseca, MD-PhD (985106121 ext. 36582, palucaji@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression symptoms (time frame: At the time of diagnosis or treatment initiation. Follow-up at 3 months: To assess the early evolution of symptoms. Follow-up at 6 months: To analyze the medium-term evolution.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.