Electronic Psycho-oncological Adaptive Screening Program

NCT04749056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2021-02-10

No results posted yet for this study

Summary

Background: Psychological burden in cancer patients may worsen quality of life and even medical outcomes such as mortality. Nevertheless, many distressed patients are not recognized by the treating clinicians and left untreated even though effective psychosocial interventions exist. Existing screenings programs have multiple limitations such as the necessity of time consuming training and involvement of clincial staff, conventional screening instruments with limited diagnostic accuracy and the focusing on objective measures of distress, thereby neglecting subjective supportive care needs.

Aims: To address some of the limitations outlined above, we developed an electronic psycho-oncological adaptive screening program (EPAS) which separately assesses distress and psychosocial care needs and provides immediate patient feedback with individualized recommendations about psychosocial care services.

Design: Patients of the intervention are compared to a control condition. All participants are assessed at three measurement points (baseline, and at 3-months and 6-months follow-up).

Outcomes: Outcomes assess aspects related to psychosocial care services, well-being and satisfaction.

Recruitment: Patients are recruited within suitable health care facilities within the University Cancer Center Hamburg (UCCH) and other facilities in the competence network of the UCCH. Patients are checked for eligibility via review of the medical chart and consecutively recruited by research assistants.

Duration of the study: From start of recruitment, 2 years are planned until data analysis. 1 year is planned for recruitment.

Analyses: We conduct group comparisons in the study outcomes, both unconditional and condcitional (controlled for care relevant co-variates).

Conditions

Interventions

BEHAVIORAL

EPAS (electronic psycho-oncological adapative screening program)

Adaptive tests assess depression, anxiety and distress. Only items with highest information value are selected. Furthermore, patients fill in a checklist to report supportive care needs. The results page contains (i) the extent of distress and additional information to interpret these levels, (ii) a summary of the reported supportive care needs and (iii) individualized recommendations for the use of psychosocial services at the institution based on the care needs. The supportive care needs are transformed into concrete recommendations to use the adequate psychosocial service at the institution. Highly distressed patients are recommended to use psycho-oncological service irrespective of whether they have reported such a need in the check list. Physicians of highly distressed patients are recommended on their results page to talk with the patient about his/her psychosocial condition and further issues within such an appointment are suggested.

Sponsors & Collaborators

  • Federal Ministry of Health, Germany

    collaborator OTHER_GOV
  • University of Leipzig

    collaborator OTHER
  • University of Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Anja Mehnert-Theuerkauf, Prof. · University of Leipzig

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-01
Primary Completion
2015-07-01
Completion
2015-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749056 on ClinicalTrials.gov