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

ClinicalTrials.gov ID

NCT07544446

Lead Sponsor

Lindenhofgruppe AGINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

148Estimated

Last Update Posted

Sep 2, 2026Actual

Start Date

Aug 25, 2026Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

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)

Brief 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.

• Cancer
• Psycho-Oncology

• initial psycho-oncological contact
• Standard

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Lindenhofgruppe AGINDUSTRY

Collaborators

Insel Gruppe AG, University Hospital BernOTHER

St. Claraspital AGOTHER

Klinik Hirslanden, ZurichOTHER

janine.antonov@lindenhofgruppe.ch+41 79 359 29 99

michael.kiessling@see-spital.ch+41 44 728 17 40

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