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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Lindenhofgruppe AG

Collaborators

Klinik Hirslanden, Zurich
St. Claraspital AG
Insel Gruppe AG, University Hospital Bern

Investigators

  • 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)

June 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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