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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| St. Claraspital AG | OTHER |
| Klinik Hirslanden, Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard | Active Comparator | Participants in the Control Arm will receive actual standard of care psycho- oncological support according to local processes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| initial psycho-oncological contact | Other | initial psycho-oncological contact and a 3 months follow-up contact |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months follow-up |
| Change in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Janine Antonov, PhD, eMBA | Forschungszentrum Lindenhofgruppe | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Claraspital | Basel | 4058 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28558713 | Background | 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. | |
| 31138239 |
| Label | URL |
|---|---|
| Swiss Guidelines on psycho-oncological care for adult cancer patients and their families | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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This study is a patient-initiated, prospective, randomised, controlled, non blinded, multicentric study
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| Standard | Other | actual standard of care psycho-oncological support according to local processes |
|
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
| 6 months follow-up |
| 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 | 6 months follow-up |
| 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 | 6 months follow-up |
| 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 | 6 months follow-up |
| Reasons for seeking or not seeking psycho-oncological support | Reasons for seeking or not seeking psycho-oncological support | 6 months follow-up |
| University Hospital Insel Gruppe AG | Bern | 3010 | Switzerland |
|
| Lindenhofgruppe | Bern | 3012 | Switzerland |
|
| See-Spital | Horgen | 8810 | Switzerland |
|
| Klinik für Hämatologie und Onkologie Hirs landen Zürich AG | Zurich | 8032 | Switzerland |
|
| 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. |
| 37999127 | 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. |
| 38231700 | 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. |
| 30512208 | 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. |
| 1251875 | 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. |
| 25287821 | 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. |