Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm

NCT04638699 | Unknown

• 1 other identifier: 70113550
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psycho-Oncology; Visceral Cancer; Screening; Psychosocial Stressor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time

  T0 (at hospital stay) and T1 (3 months later)

• Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time

  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

  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

  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

  T0 (at hospital stay) and T1 (3 months later)

Study Arms (2)

Phase 1 Survey of the actual state

NO INTERVENTION

Phase 2 Survey after the OptiScreen training

OTHER

Other: OptiScreen training

Interventions

OptiScreen training OTHER

Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress

Phase 2 Survey after the OptiScreen training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe physical, cognitive and/or language limitations

Sponsors & Collaborators

• Hannover Medical School: lead
• Universitätsklinikum Leipzig: collaborator
• UniversitätsKrebsCentrum Dresden: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Germany

RECRUITING

Study Officials

• Tanja Zimmermann

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Zimmermann, Prof.

CONTACT

+49511532; zimmermann.tanja@mh-hannover.de

Tanja Zimmermann

CONTACT

05115323133; zimmermann.tanja@mh-hannover.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Tanja Zimmermann

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 20, 2020
• Study Start: April 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

DE (1)