Psycho-OncologyOptiScreenNCT04638699
Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm
A study testing OptiScreen training in people with Psycho-Oncology and Visceral Cancer, run by Hannover Medical School at 1 site in Germany.
Trial summary
Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their relatives and to improving the quality of life. There is still a need for clarification regarding the need and the determination of psychosocial needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psycho-Oncology, Visceral Cancer, Screening
- What is being tested?
- OptiScreen training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-patients of the visceral oncology centers at the three locations
Who cannot join
- severe physical, cognitive and/or language limitations
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover
Tanja Zimmermann
About this study
Official title: Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm: From Screening to Intervention
Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their relatives and to improving the quality of life. There is still a need for clarification regarding the need and the determination of psychosocial needs. This multi-center study (3 centers: Hanover, Leipzig and Dresden) aims at a professionalization of psychosocial screening, in order to enable thus an exact and need-based allocation to psycho-oncological support. The optimization and professionalization of the psychosocial screening process shall be achieved by a training of oncological nursing and development of an interdisciplinary care algorithm. The aim is to examine whether "OptiScreen" increases the targeted and needs-based allocation to psycho-oncology.
Read the detailed description
Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their families and to improving the quality of life of all those affected. In order to ensure patient-oriented psycho-oncological care, it is necessary to allocate psychologically burdened patients and patients in need of care to psycho-oncology by means of screening.
Within the framework of this multicenter study (Hannover, Leipzig and Dresden), a newly designed training of nursing staff ("OptiScreen training") on mental stress and psycho-oncological care is intended to increase the precise identification of mentally stressed patients in need of treatment, to increase the allocation of these patients to psycho-oncology and to improve interdisciplinary cooperation.
Aims of the study:
- targeted, needs-based allocation to psycho-oncology
- increasing the acceptance of psycho-oncological screening by patients* and treatment team
- increase of patient competence and satisfaction
- increasing the acceptance of psycho-oncological treatment by patients and treatment team In summary, the findings of this multi-center study should contribute to the improvement of interdisciplinary cooperation, improve the demand-oriented and targeted allocation of psychologically burdened patients to psycho-oncological care and thus develop a "best practice model" of an interdisciplinary care algorithm.
Methodology
The study will include inpatients from the visceral oncology centers at the three sites who have the necessary cognitive, physical and linguistic abilities. The study is divided into 2 phases:
Phase 1: Survey of the current status For this purpose, N = 300 patients* in the visceral oncology centers are interviewed with a questionnaire during the inpatient stay (t0) and three months later (t1).
The data collected will include psychological stress, disease management/treatment, quality of life and treatment satisfaction of persons with oncological diseases. In addition, the needs for information and support, the practicability as well as the allocation to psycho-oncological care and its utilization will be surveyed.
Execution of the "OptiScreen training": special psycho-oncological training of the nursing staff for basic knowledge about the experience of psychological stress as well as diagnostics of psychosocial stress will take place after the completion of phase 1.
Phase 2: survey after the OptiScreen training Analogous to phase 1, N = 600 patients* in the visceral oncology centers are interviewed during the inpatient stay (t0) and three months later (t1).
- Conditions
- Psycho-Oncology, Visceral Cancer, Screening, Psychosocial Stressor
- Being tested
- OptiScreen training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiScreen trainingOther
Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Survey of the actual state | No intervention | Not described |
| Phase 2 Survey after the OptiScreen training | Other | Not described Receives: Other: OptiScreen training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time
Distress Thermometer (NCCN Distress Thermometer)
Measured: T0 (at hospital stay) and T1 (3 months later)
Secondary outcomes (12)
Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time
Patient Health Questionnaire (PHQ-9)
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time
Generalized Anxiety Disorder 7 (GAD-7)
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time
Supportive Care Needs Survey Short Form German (SCNS-SF34-G)
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time
Progredienangstfragebogen (PA-F; Fear of Progression Questionnaire)
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time
Short Form-8 Health Survey SF-8
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time
Quality of Marriage Index (QMI)
Measured: T0 (at hospital stay) and T1 (3 months later)
Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time
REPERES-G: Assessment of care
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of health competence (Access to information, understanding, evaluating and applying of information) in cancer patients (CG vs. IG) and changes over time
European Health Literacy Questionnaire
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time
Patient Activation Measure (PAM 13D; German version of the Patient Measure
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time
Body-Image-Scale
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time
Scales for social support during illness (SSUK Skalen zur sozialen Unterstützung bei Krankheit) zur sozialen Unterstützung bei Krankheit-8 (SSUK-8; llness-specific Social Support Scale)
Measured: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of resources (Health promoting activities, active participation, emotional stress, self-monitoring etc.in cancer patients (CG vs. IG) and changes over time
Health Education Impact Questionnaire
Measured: T0 (at hospital stay) and T1 (3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psycho-OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, UniversitätsKrebsCentrum Dresden
- Responsible party
- Principal investigator, Zimmermann, Tanja Prof. Dr., Hannover Medical School
- Investigators
- Tanja Zimmermann, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638699
- Sponsor's protocol ID
- 70113550
- Acronym
- OptiScreen
- Status last verified
- Feb 2023
- First submitted
- 2 Nov 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm: From Screening to Intervention
- ClinicalTrials.gov ID
- NCT04638699
- Acronym / sponsor ID
- OptiScreen / 70113550
- Conditions
- Psycho-Oncology, Visceral Cancer, Screening, Psychosocial Stressor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, UniversitätsKrebsCentrum Dresden
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their relatives and to improving the quality of life. There is still a need for clarification regarding the need and the determination of psychosocial needs. This multi-center study (3 centers: Hanover, Leipzig and Dresden) aims at a professionalization of psychosocial screening, in order to enable thus an exact and need-based allocation to psycho-oncological support. The optimization and professionalization of the psychosocial screening process shall be achieved by a training of oncological nursing and development of an interdisciplinary care algorithm. The aim is to examine whether "OptiScreen" increases the targeted and needs-based allocation to psycho-oncology.
Detailed description
Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their families and to improving the quality of life of all those affected. In order to ensure patient-oriented psycho-oncological care, it is necessary to allocate psychologically burdened patients and patients in need of care to psycho-oncology by means of screening.
Within the framework of this multicenter study (Hannover, Leipzig and Dresden), a newly designed training of nursing staff ("OptiScreen training") on mental stress and psycho-oncological care is intended to increase the precise identification of mentally stressed patients in need of treatment, to increase the allocation of these patients to psycho-oncology and to improve interdisciplinary cooperation.
Aims of the study:
- targeted, needs-based allocation to psycho-oncology
- increasing the acceptance of psycho-oncological screening by patients* and treatment team
- increase of patient competence and satisfaction
- increasing the acceptance of psycho-oncological treatment by patients and treatment team In summary, the findings of this multi-center study should contribute to the improvement of interdisciplinary cooperation, improve the demand-oriented and targeted allocation of psychologically burdened patients to psycho-oncological care and thus develop a "best practice model" of an interdisciplinary care algorithm.
Methodology
The study will include inpatients from the visceral oncology centers at the three sites who have the necessary cognitive, physical and linguistic abilities. The study is divided into 2 phases:
Phase 1: Survey of the current status For this purpose, N = 300 patients* in the visceral oncology centers are interviewed with a questionnaire during the inpatient stay (t0) and three months later (t1).
The data collected will include psychological stress, disease management/treatment, quality of life and treatment satisfaction of persons with oncological diseases. In addition, the needs for information and support, the practicability as well as the allocation to psycho-oncological care and its utilization will be surveyed.
Execution of the "OptiScreen training": special psycho-oncological training of the nursing staff for basic knowledge about the experience of psychological stress as well as diagnostics of psychosocial stress will take place after the completion of phase 1.
Phase 2: survey after the OptiScreen training Analogous to phase 1, N = 600 patients* in the visceral oncology centers are interviewed during the inpatient stay (t0) and three months later (t1).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Survey of the actual state | No intervention | – |
| Phase 2 Survey after the OptiScreen training | Other | Other: OptiScreen training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-patients of the visceral oncology centers at the three locations
Key exclusion criteria (1 listed)
- severe physical, cognitive and/or language limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptiScreen trainingSpecial psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress | Other | Phase 2 Survey after the OptiScreen training |
Primary outcome
Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Distress Thermometer (NCCN Distress Thermometer)
12 secondary outcomes
Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of health competence (Access to information, understanding, evaluating and applying of information) in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Frequency and extent of resources (Health promoting activities, active participation, emotional stress, self-monitoring etc.in cancer patients (CG vs. IG) and changes over time
Time frame: T0 (at hospital stay) and T1 (3 months later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Zimmermann principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OptiScreen training in people with Psycho-Oncology and Visceral Cancer, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanja Zimmermann, Prof. (+49511532 ext. 3133, zimmermann.tanja@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time (time frame: T0 (at hospital stay) and T1 (3 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.