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CancerPICSNCT07544446

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

A study testing initial psycho-oncological contact and Standard in people with Cancer and Psycho-Oncology, run by Lindenhofgruppe AG at 5 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Psycho-Oncology
What is being tested?
initial psycho-oncological contact and Standard
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
5 sitesSwitzerland
Study dates
25 Aug 2026to 31 Dec 2028
Phase
Interventional
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janine Antonov, PhD, eMBA contact

+41 79 359 29 99

janine.antonov@lindenhofgruppe.ch

Forschungszentrum Lindenhofgruppe contact

+41 31 366 36 66

forschungszentrum@lindenhofgruppe.ch

5 sites in 1 country

Switzerland5 sites, 5 recruiting

  • St. Claraspital

    Basel, 4058

    Arnoud Templeton, Prof. Dr. med., +41 61 685 84 39, arnoud.templeton@claraspital.ch

    Arnoud Templeton, Prof. Dr. med.

    Not yet recruiting

  • University Hospital Insel Gruppe AG

    Bern, 3010

    Alexander Wünsch, Prof. Dr. phil., +41 31 632 27 05, alexander.wuensch@insel.ch

    Alexander Wünsch, Prof. Dr. phil.

    Not yet recruiting

  • Lindenhofgruppe

    Bern, 3012

    Janine Antonov, PhD, eMBA, +41 79 359 29 99, janine.antonov@lindenhofgruppe.ch

    Janine Antonov, PhD, eMBA

    Recruiting

  • See-Spital

    Horgen, 8810

    Michael Kiessling, Dr. med. Dr. rer. nat., +41 44 728 17 40, michael.kiessling@see-spital.ch

    Michael Kiessling, Dr. med. Dr. rer. nat.

    Not yet recruiting

  • Klinik für Hämatologie und Onkologie Hirs landen Zürich AG

    Zurich, 8032

    Karin Hohloch, PD Dr., + 41 44 387 37 92, karin.hohloch@kho.ch

    Karin Hohloch, PD Dr.

    Not yet recruiting

Other trials in Switzerland

About this study

Official 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)

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.

Read more

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.

Being tested
initial psycho-oncological contact, Standard
Keywords
cancer, Psycho-Oncology, Adults, anxiety and depression, quality of life, distress thermometer, systemic oncologic treatment, radiotherapy
Medical subject headings
Neoplasms, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • initial psycho-oncological contactOther

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

  • StandardOther

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

Study groups in NCT07544446
Study groupRoleWhat they receive
Initial psycho-oncological contactExperimentalParticipants in the Intervention Arm will be contacted by a psycho-oncological counsellor. The study intervention is a 45 minutes initial psycho-oncological counselling and 3 months follow-up contact.
Receives: Other: initial psycho-oncological contact
StandardActive comparatorParticipants in the Control Arm will receive current standard of care psycho- oncological support according to local processes.
Receives: Other: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in anxiety and depression

    Change in anxiety and depression from study entry to the 6 months follow-up survey, measured using a summary measure of the entire HADS

    Measured: 6 months follow-up

Secondary outcomes (6)

  1. Change in anxiety and depression components

    Change in anxiety and depression components, from study entry to the 6 months follow-up survey, measured using the HADS subscales anxiety / depression

    Measured: 6 months follow-up

  2. Change in quality of life

    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

    Measured: 6 months follow-up

  3. Change in quality-of-life components

    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

    Measured: 6 months follow-up

  4. Change in patient's global distress

    Change in patient's global distress, from study entry to the 6 months follow-up survey, measured using the distress thermometer

    Measured: 6 months follow-up

  5. Use of psycho-oncological support

    Use of psycho-oncological support, measured as quantity of psycho oncological support from study entry to 6 months follow-up

    Measured: 6 months follow-up

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

    Reasons for seeking or not seeking psycho-oncological support

    Measured: 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start25 Aug 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Parallel groups
Model description
This study is a patient-initiated, prospective, randomised, controlled, non blinded, multicentric study
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07544446
Sponsor's protocol ID
Schobinger_24-02_PIP_PICS
Acronym
PICS
Status last verified
Aug 2026
First submitted
15 Apr 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zwahlen D, Tondorf T, Rothschild S, Koller MT, Rochlitz C, Kiss A. Understanding why cancer patients accept or turn down psycho-oncological support: a prospective observational study including patients' and clinicians' perspectives on communication about distress. BMC Cancer. 2017 May 30;17(1):385. doi: 10.1186/s12885-017-3362-x.

    PubMed 28558713

  • Fang L, Chuang DM, Al-Raes M. Social support, mental health needs, and HIV risk behaviors: a gender-specific, correlation study. BMC Public Health. 2019 May 28;19(1):651. doi: 10.1186/s12889-019-6985-9.

    PubMed 31138239

  • Hecht K, Gunther MP, Kirchebner J, Gotz A, von Kanel R, Schulze JB, Euler S. Predictive Factors Associated with Declining Psycho-Oncological Support in Patients with Cancer. Curr Oncol. 2023 Nov 4;30(11):9746-9759. doi: 10.3390/curroncol30110707.

    PubMed 37999127

  • Singer S, Wunsch A, Ihrig A, Bruns G, Holz F, Jakob J, Besseler M, Engesser D, Blettner M, Konig J, Bayer O. Men's Access to Outpatient Psychosocial Cancer Counseling-a Cluster-Randomized Trial. Dtsch Arztebl Int. 2024 Feb 23;121(4):121-127. doi: 10.3238/arztebl.m2024.0005.

    PubMed 38231700

  • Senf B, Fettel J, Demmerle C, Maiwurm P. Physicians' attitudes towards psycho-oncology, perceived barriers, and psychosocial competencies: Indicators of successful implementation of adjunctive psycho-oncological care? Psychooncology. 2019 Feb;28(2):415-422. doi: 10.1002/pon.4962. Epub 2018 Dec 21.

    PubMed 30512208

  • Mizuno K, Watanabe T. Sarcoid granulomatous cyclitis. Am J Ophthalmol. 1976 Jan;81(1):82-5. doi: 10.1016/0002-9394(76)90195-1.

    PubMed 1251875

  • Mehnert A, Brahler E, Faller H, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Boehncke A, Hund B, Reuter K, Richard M, Sehner S, Sommerfeldt S, Szalai C, Wittchen HU, Koch U. Four-week prevalence of mental disorders in patients with cancer across major tumor entities. J Clin Oncol. 2014 Nov 1;32(31):3540-6. doi: 10.1200/JCO.2014.56.0086. Epub 2014 Oct 6.

    PubMed 25287821

Questions about this trial

What is this clinical trial studying?

A study testing initial psycho-oncological contact and Standard in people with Cancer and Psycho-Oncology, run by Lindenhofgruppe AG at 5 sites in Switzerland.

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 5 inclusion and 5 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. 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 Janine Antonov, PhD, eMBA (+41 79 359 29 99, janine.antonov@lindenhofgruppe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anxiety and depression (time frame: 6 months follow-up). 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 NCT07544446, which also lists 7 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 2 Sep 2026.

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