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

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)

Overview

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.

Interventions

• Other initial psycho-oncological contact
  initial psycho-oncological contact and a 3 months follow-up contact
• Other Standard
  actual standard of care psycho-oncological support according to local processes

Primary outcome measures

• Change in anxiety and depression [Time frame: 6 months follow-up]

Secondary outcome measures (6)

• Change in anxiety and depression components [Time frame: 6 months follow-up]
• Change in quality of life [Time frame: 6 months follow-up]
• Change in quality-of-life components [Time frame: 6 months follow-up]
• Change in patient's global distress [Time frame: 6 months follow-up]
• Use of psycho-oncological support [Time frame: 6 months follow-up]
• Reasons for seeking or not seeking psycho-oncological support [Time frame: 6 months follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Switzerland · 5 centers

• St. Claraspital — Basel
• University Hospital Insel Gruppe AG — Bern
• Lindenhofgruppe — Bern
• See-Spital — Horgen
• Klinik für Hämatologie und Onkologie Hirs landen Zürich AG — Zurich

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 25287821

Identifiers

NCT: NCT07544446 · Schobinger_24-02_PIP_PICS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗