Cancer, Psycho-Oncology
Conditions
Keywords
cancer, Psycho-Oncology, Adults, anxiety and depression, quality of life, distress thermometer, systemic oncologic treatment, radiotherapy
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.
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
Sponsors
Lindenhofgruppe AG
Insel Gruppe AG, University Hospital Bern
St. Claraspital AG
Klinik Hirslanden, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study is a patient-initiated, prospective, randomised, controlled, non blinded, multicentric study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety and depression | 6 months follow-up | Change in anxiety and depression from study entry to the 6 months follow-up survey, measured using a summary measure of the entire HADS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety and depression components | 6 months follow-up | Change in anxiety and depression components, from study entry to the 6 months follow-up survey, measured using the HADS subscales anxiety / depression |
| Change in quality of life | 6 months follow-up | 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 |
| Change in quality-of-life components | 6 months follow-up | 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 |
| Change in patient's global distress | 6 months follow-up | Change in patient's global distress, from study entry to the 6 months follow-up survey, measured using the distress thermometer |
| Use of psycho-oncological support | 6 months follow-up | Use of psycho-oncological support, measured as quantity of psycho oncological support from study entry to 6 months follow-up |
| Reasons for seeking or not seeking psycho-oncological support | 6 months follow-up | Reasons for seeking or not seeking psycho-oncological support |
Countries
Switzerland
Contacts
CONTACTJanine Antonov, PhD, eMBA
CONTACTForschungszentrum Lindenhofgruppe
STUDY_CHAIRJanine Antonov, PhD, eMBA
Forschungszentrum Lindenhofgruppe
Outcome results
None listed