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

NCT07544446 | Not Yet Recruiting

• 1 other identifier: Schobinger_24-02_PIP_PICS
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

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.

Conditions

Psycho-Oncology; Cancer

Keywords

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

Outcome Measures

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

  6 months follow-up

Secondary Outcomes (6)

• Change in anxiety and depression components

  6 months follow-up

• Change in quality of life

  6 months follow-up

• Change in quality-of-life components

  6 months follow-up

• Change in patient's global distress

  6 months follow-up

• Use of psycho-oncological support

  6 months follow-up

Study Arms (2)

Initial psycho-oncological contact

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

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

Other: Standard

Interventions

initial psycho-oncological contact OTHER

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

Initial psycho-oncological contact

Standard OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindenhofgruppe AG: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• St. Claraspital AG: collaborator
• Klinik Hirslanden, Zurich: collaborator

Study Sites (5)

St. Claraspital

Basel, 4058, Switzerland

Location

University Hospital Insel Gruppe AG

Bern, 3010, Switzerland

Location

Lindenhofgruppe

Bern, 3012, Switzerland

Location

See-Spital

Horgen, 8810, Switzerland

Location

Klinik für Hämatologie und Onkologie Hirs landen Zürich AG

Zurich, 8032, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 28558713 BACKGROUND

• 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.

  PMID: 31138239 BACKGROUND

• 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.

  PMID: 37999127 BACKGROUND

• 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.

  PMID: 38231700 BACKGROUND

• 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.

  PMID: 30512208 BACKGROUND

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

  PMID: 1251875 BACKGROUND

• 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.

  PMID: 25287821 BACKGROUND

Related Links

• Swiss Guidelines on psycho-oncological care for adult cancer patients and their families

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Janine Antonov, PhD, eMBA

  Forschungszentrum Lindenhofgruppe

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a patient-initiated, prospective, randomised, controlled, non blinded, multicentric study

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)