What Impact Does an Initial Psycho-oncological Contact Have on People With Cancer? (PICS)

April 15, 2026 updated by: Lindenhofgruppe AG

The Impact of a Standardised Initial Contact by a Psycho-oncological Counsellor on Anxiety and Depression, Quality of Life and the Use of Psycho-oncological Support in Cancer Patients: A Patient-initiated Multicentre Randomised Controlled Study - the Psycho-oncological Initial Contact Study (PICS)

When diagnosed with cancer, patients or their relatives may, if they wish, on the recommendation of the treatment team and/or in cases of high stress, seek psycho-oncological support.

This study investigates whether an initial consultation with a psycho-oncological specialist reduces anxiety and depression, improves quality of life, and whether patients subsequently make greater use of support services.

Participants will be randomised, meaning they will be assigned to groups at random to ensure that the results are comparable. In the intervention group, participants will receive a detailed initial consultation with a psycho-oncology specialist and standard treatment. In the control group, participants receive standard treatment. To gather results, questionnaires are administered at regular intervals (at the start, after 3 and 6 months). The study lasts a total of 6 months.

The study was developed by patients. It is being conducted simultaneously at several hospitals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4058
        • St. Claraspital
        • Contact:
        • Principal Investigator:
          • Arnoud Templeton, Prof. Dr. med.
      • Bern, Switzerland, 3010
        • University Hospital Insel Gruppe AG
        • Contact:
        • Principal Investigator:
          • Alexander Wünsch, Prof. Dr. phil.
      • Bern, Switzerland, 3012
        • Lindenhofgruppe
        • Contact:
        • Principal Investigator:
          • Janine Antonov, PhD, eMBA
      • Horgen, Switzerland, 8810
        • See-Spital
        • Contact:
        • Principal Investigator:
          • Michael Kiessling, Dr. med. Dr. rer. nat.
      • Zurich, Switzerland, 8032
        • Klinik für Hämatologie und Onkologie Hirs landen Zürich AG
        • Contact:
        • Principal Investigator:
          • Karin Hohloch, PD Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with an oncological disease diagnosed within the last 3 months with planned or ongoing systemic oncologic treatment (e.g. chemotherapy, immunotherapy, hormone therapy) or a planned or ongoing radiotherapy
  • Patient is ≥18 years of age and legally competent
  • Patients must have understood and signed the study information and the informed consent form
  • Patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the informed consent
  • No previous contact with psycho-oncological services

Exclusion Criteria:

  • Documented severe functional impairment according to the ECOG Performance Status (ECOG 3-4)
  • Patients receiving or planned to receive treatments associated with a severe risk of toxicity (e.g., CAR-T cell therapy, myeloablative therapy)
  • Insufficient language skills in German
  • Inability to give informed consent
  • Refusal to participate in the study, unsigned informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Initial psycho-oncological contact
Participants in the Intervention Arm will be contacted by a psycho-oncological counsellor. The study intervention is a 45 minutes psycho-oncological counselling and a 3 months follow-up contact.
Other: initial psycho-oncological contact
initial psycho-oncological contact and a 3 months follow-up contact
Active Comparator: Standard
Participants in the Control Arm will receive actual standard of care psycho- oncological support according to local processes.
Other: Standard
actual standard of care psycho-oncological support according to local processes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in anxiety and depression
Time Frame: 6 months follow-up
Change in anxiety and depression from study entry to the 6 months follow-up survey, measured using a summary measure of the entire HADS
6 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in anxiety and depression components
Time Frame: 6 months follow-up
Change in anxiety and depression components, from study entry to the 6 months follow-up survey, measured using the HADS subscales anxiety / depression
6 months follow-up
Change in quality of life
Time Frame: 6 months follow-up
Change in quality of life, from study entry to the 6 months follow-up survey, measured using a summary measure of the entire EORTC QLQ C30
6 months follow-up
Change in quality-of-life components
Time Frame: 6 months follow-up
Change in quality-of-life components, from study entry to the 6 months follow-up survey, measured using the EORTC QLQ C30 subscales global / functional / symptoms
6 months follow-up
Change in patient's global distress
Time Frame: 6 months follow-up
Change in patient's global distress, from study entry to the 6 months follow-up survey, measured using the distress thermometer
6 months follow-up
Use of psycho-oncological support
Time Frame: 6 months follow-up
Use of psycho-oncological support, measured as quantity of psycho oncological support from study entry to 6 months follow-up
6 months follow-up
Reasons for seeking or not seeking psycho-oncological support
Time Frame: 6 months follow-up
Reasons for seeking or not seeking psycho-oncological support
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lindenhofgruppe AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Klinik Hirslanden, Zurich
St. Claraspital AG
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Janine Antonov, PhD, eMBA, Forschungszentrum Lindenhofgruppe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Schobinger_24-02_PIP_PICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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