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RecruitingNCT07544446PICSUpdated Sep 2, 2026

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

An interventional study of initial psycho-oncological contact and Standard in Cancer and Psycho-Oncology, sponsored by Lindenhofgruppe AG. Recruiting at 5 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Lindenhofgruppe AG · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Cancer
  • Psycho-Oncology

Keywords

  • cancer
  • Psycho-Oncology
  • Adults
  • anxiety and depression
  • quality of life
  • distress thermometer
  • systemic oncologic treatment
  • radiotherapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • 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 initial psycho-oncological counselling and 3 months follow-up contact.

    Other: initial psycho-oncological contact

  • Active comparator
    Standard

    Participants in the Control Arm will receive current standard of care psycho- oncological support according to local processes.

    Other: Standard

Interventions

  • Otherinitial psycho-oncological contact

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

  • OtherStandard

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

05

What researchers measure

Primary outcomes

  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

    Time frame: 6 months follow-up

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 6 months follow-up

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

    Reasons for seeking or not seeking psycho-oncological support

    Time frame: 6 months follow-up

06

Study locations

1 of 5 sites recruiting
  • St. Claraspital
    Basel, 4058, Switzerland
    • Arnoud Templeton, Prof. Dr. med. · Contact · arnoud.templeton@claraspital.ch · +41 61 685 84 39
    • Arnoud Templeton, Prof. Dr. med. · Principal investigator
    Not yet recruiting
  • University Hospital Insel Gruppe AG
    Bern, 3010, Switzerland
    • Alexander Wünsch, Prof. Dr. phil. · Contact · alexander.wuensch@insel.ch · +41 31 632 27 05
    • Alexander Wünsch, Prof. Dr. phil. · Principal investigator
    Not yet recruiting
  • Lindenhofgruppe
    Bern, 3012, Switzerland
    Recruiting
  • See-Spital
    Horgen, 8810, Switzerland
    • Michael Kiessling, Dr. med. Dr. rer. nat. · Contact · michael.kiessling@see-spital.ch · +41 44 728 17 40
    • Michael Kiessling, Dr. med. Dr. rer. nat. · Principal investigator
    Not yet recruiting
  • Klinik für Hämatologie und Onkologie Hirs landen Zürich AG
    Zurich, 8032, Switzerland
    • Karin Hohloch, PD Dr. · Contact · karin.hohloch@kho.ch · + 41 44 387 37 92
    • Karin Hohloch, PD Dr. · Principal investigator
    Not yet recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07544446
Lead sponsor
Lindenhofgruppe AG
Collaborators
Insel Gruppe AG, University Hospital Bern, St. Claraspital AG, Klinik Hirslanden, Zurich
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Aug 25, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Janine Antonov, PhD, eMBA
Contact
janine.antonov@lindenhofgruppe.ch
+41 79 359 29 99
Forschungszentrum Lindenhofgruppe
Contact
forschungszentrum@lindenhofgruppe.ch
+41 31 366 36 66
Janine Antonov, PhD, eMBA
study chair · Forschungszentrum Lindenhofgruppe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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