What Impact Does an Initial Psycho-oncological Contact Have on People With Cancer?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLindenhofgruppe AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
initial psycho-oncological contact
Other interventioninitial psycho-oncological contact and 3 months follow-up contact
Standard
Other interventioncurrent standard of care psycho-oncological support according to local processes
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Initial psycho-oncological contactExperimental treatment 1 intervention
Group B: StandardActive comparator 1 intervention
Trial outcomes
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
Time frame
6 months follow-upSecondary outcomes
1
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
Time frame
6 months follow-up2
Change in quality of life
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
Time frame
6 months follow-up3
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
Time frame
6 months follow-up4
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
Time frame
6 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lindenhofgruppe AG
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
St. Claraspital AG
Collaborator
Klinik Hirslanden, Zurich
Collaborator
Source ClinicalTrials.gov