Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm (OptiScreen)

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.

Study Overview

• Status: Recruiting
• Conditions: Screening; Psycho-Oncology; Visceral Cancer; Psychosocial Stressor
• Intervention / Treatment: Other: OptiScreen training

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:

1. targeted, needs-based allocation to psycho-oncology
2. increasing the acceptance of psycho-oncological screening by patients* and treatment team
3. increase of patient competence and satisfaction
4. 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 Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanja Zimmermann, Prof.; Phone Number: 3133 +49511532; Email: zimmermann.tanja@mh-hannover.de
• Study Contact Backup: Name: Tanja Zimmermann; Phone Number: 05115323133; Email: zimmermann.tanja@mh-hannover.de

Study Locations

• Germany
  • Hanover, Germany
    • Recruiting
    • Hannover Medical School
    • Contact: Tanja Zimmermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• In-patients of the visceral oncology centers at the three locations

Exclusion Criteria:

• severe physical, cognitive and/or language limitations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Phase 1 Survey of the actual state
Other: Phase 2 Survey after the OptiScreen training	Other: OptiScreen training; Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time	Distress Thermometer (NCCN Distress Thermometer)	T0 (at hospital stay) and T1 (3 months later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time	Patient Health Questionnaire (PHQ-9)	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)	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)	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)	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	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)	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	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	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	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	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)	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	T0 (at hospital stay) and T1 (3 months later)

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Universitätsklinikum Leipzig; UniversitätsKrebsCentrum Dresden
• Investigators: Principal Investigator: Tanja Zimmermann, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 70113550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No