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NCT Number: NCT07544446

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

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.

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Key information

Conditions

Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neoplasms Psycho-Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Claraspital, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

initial psycho-oncological contact

Other

initial psycho-oncological contact and a 3 months follow-up contact

standard

Other

actual standard of care psycho-oncological support according to local processes

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. Reasons for seeking or not seeking psycho-oncological support

    Time frame: 6 months follow-up

    Reasons for seeking or not seeking psycho-oncological support

Study contacts

Contact information is provided by the study sponsor or research team.

Forschungszentrum Lindenhofgruppe

CONTACT

[email protected]

+41 31 366 36 66

Janine Antonov, PhD, eMBA

CONTACT

[email protected]

+41 79 359 29 99

Sponsors and collaborators

Lead sponsor

Lindenhofgruppe AG

Industry

Collaborators

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

Registry information

Official study title

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)

Acronym: PICS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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