Electronic Psycho-oncological Adaptive Screening Program

NCT04749056 | Completed

• 1 other identifier: EPAS_Intervention
• Study Type: interventional
• Target: 660
• Locations: 0 countries
• Sites: N/A

Brief 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

Cancer

Outcome Measures

Primary Outcomes (13)

• Information level about psychosocial services at 3 months-follow-up

  On 10 items, patients rate their level of information for each of the 10 available psychosocial services on a scale from 0 to 4, with higher values indicating a higher level of information. Items are evaluated as single scales.

  The outcome is assessed at T1 (3-months follow-up).

• Information level about psychosocial services at 6 months-follow-up

  On 10 items, patients rate their level of information for each of the 10 available psychosocial services on a scale from 0 to 4, with higher values indicating a higher level of information. Items are evaluated as single scales.

  The outcome is assessed at T2 (six months follow-up).

• Use of the psychosocial services at 3-months follow-up

  On an internally developed questionnaire, patients rate on 10 binary items (yes/no) whether they have used each of the 10 psychosocial services available at the study center. The items are analysed as single scales.

  The outcome is assessed at T1 (3-months follow-up).

• Use of the psychosocial services at 6-months follow-up

  On an internally developed questionnaire, patients rate on 10 binary items (yes/no) whether they have used each of the 10 psychosocial services available at the study center. The items are analysed as single scales.

  The outcome is assessed at T2 (six months follow-up).

• Evaluation of access to psychosocial services

  On 4 nominal items (yes/no/do not know), we assess whether any i) communication with the physicians about supportive/complementary care needs, ii) recommendations by the physicians for psychosocial services, iii) concrete offers by the physicians to use a psychosocial service or iv) request by the physicians for a consultation service have taken place.

  The outcome is assessed at T1 (3-months follow-up).

• Depressive symptomatology at 3-months follow-up

  PHQ-9: On 9 items, patients rate the frequency of depressive symptoms on a scale from 0 to 3, with higher scores indicating a higher symptomatology (range of sum score: 0 - 27).

  The outcome is assessed at T1 (3-months follow-up).

• Depressive symptomatology at 6-months follow-up

  PHQ-9: On 9 items, patients rate the frequency of depressive symptoms on a scale from 0 to 3, with higher scores indicating a higher symptomatology (range of sum score: 0 - 27).

  The outcome is assessed at T2 (six months follow-up).

• Anxious symptomatology at 3-months follow-up

  GAD-7: On 7 items, patients rate the frequency of anxious symptoms on a scale from 0 to 3, with higher values indicating higher level of anxiety (range of sum score: 0 - 21).

  The outcome is assessed at T1 (3-months follow-up).

• Anxious symptomatology at 6-months follow-up

  GAD-7: On 7 items, patients rate the frequency of anxious symptoms on a scale from 0 to 3, with higher values indicating higher level of anxiety (range of sum score: 0 - 21).

  The outcome is assessed at T2 (6-months follow-up).

• Health-related quality of life at 3-months follow-up

  SF-8: On 8 items, patients rate their impairments of health-related quality of life across different areas on items ranging from 0 to 5/6. Items are later transformed on a scale from 0 to 100, with higher values indicating a higher level of quality of life.

  The outcome is assessed at T1 (3-months follow-up).

• Health-related quality of life at 6-months follow-up

  SF-8: On 8 items, patients rate their impairments of health-related quality of life across different areas on items ranging from 0 to 5/6. Items are later transformed on a scale from 0 to 100, with higher values indicating a higher level of quality of life.

  The outcome is assessed at T2 (6-months follow-up).

• Treatment satisfaction at 3-months follow-up

  On 32 items, patients rate their satisfaction with medical and psychosocial cancer care on a scale ranging from 1 to 5/6, with higher scores indicating higher level of satisfaction. The questionnaire is analysed by sum scores across specific subscales (Competence, Information, Access, Support, Overall medical treatment, Overall psychosocial treatment).

  The outcome is assessed at T1 (3-months follow-up).

• Treatment satisfaction at 6-months follow-up

  On 32 items, patients rate their satisfaction with medical and psychosocial cancer care on a scale ranging from 1 to 5/6, with higher scores indicating higher level of satisfaction. The questionnaire is analysed by sum scores across specific subscales (Competence, Information, Access, Support, Overall medical treatment, Overall psychosocial treatment).

  The outcome is assessed at T2 (6-months follow-up).

Study Arms (2)

EPAS screening (intervention)

EXPERIMENTAL

Patients undergo EPAS (electronic psycho-oncological adaptive screening), a tablet-based screening application consisting of three adaptive tests and one supportive care checklist. EPAS provides immediate feedback via a printed results page, which presents and interprets the level of distress and contains individualized recommendations for psychosocial services. The results pages are printed by research assistants immediately after the screening on a mobile printer and given to the participants together with a brochure containing information about all psychosocial services available at the health care institution. The treating physicians also receive a slightly modified results page, but are not expected to discuss these with the patient unless they are highly distressed. Before and during the screening, patients are explained how to use the program by the research assistance and supported if needed. The whole screening process takes about 30 minutes.

Behavioral: EPAS (electronic psycho-oncological adapative screening program)

Care as usual (control)

NO INTERVENTION

Patients complete the assessment paper pencil. The same instruments as in the intervention condition are used except for the 3 adaptive tests (i.e., the supportive care checklist and the outcomes). Neither patients nor physicians receive any feedback of the results. Psychosocial services are recommended by the physicians on their own discretion only, and patients are not handed out the information brochure.

Interventions

EPAS (electronic psycho-oncological adapative screening program) BEHAVIORAL

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.

EPAS screening (intervention)

Eligibility Criteria

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

You may qualify if:

• minimum age of 18 years
• diagnosed with any malignancy according to ICD-10 (first diagnosis or relapse)

You may not qualify if:

• Patients with any impairments interfering with the ability to give informed consent

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead
• Federal Ministry of Health, Germany: collaborator
• University of Leipzig: collaborator

Related Publications (2)

• Springer F, Sautier L, Schilling G, Koch-Gromus U, Bokemeyer C, Friedrich M, Mehnert-Theuerkauf A, Esser P. Effect of depression, anxiety, and distress screeners on the need, intention, and utilization of psychosocial support services among cancer patients. Support Care Cancer. 2023 Jan 16;31(2):117. doi: 10.1007/s00520-023-07580-2.

  PMID: 36645499 DERIVED

• Esser P, Sautier L, Sarkar S, Schilling G, Bokemeyer C, Koch U, Rose M, Friedrich M, Nolte S, Walter O, Mehnert-Theuerkauf A. Evaluation of an electronic psycho-oncological adaptive screening program (EPAS) with immediate patient feedback: findings from a German cluster intervention study. J Cancer Surviv. 2022 Dec;16(6):1401-1413. doi: 10.1007/s11764-021-01121-8. Epub 2021 Nov 4.

  PMID: 34735695 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Anja Mehnert-Theuerkauf, Prof.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Anja Mehnert-Theuerkauf

Model Details: Non-randomized controlled evaluation study (cluster crossover design) to test a screening program to assess psychological burden and supportive care needs among cancer patients. Patients undergoing the screening (intervention group) will be compared to patients without the screeninig (control group). The study has three measurement points: T0 (before the intervention), T1 (3 months after the intervention) and T2 (6 months after the intervention). Care relevant outcomes which are not yet relevant at T0 (information level, use of psychosocial services, treatment satisfaction) will be assessed at T1 and T2.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 10, 2021
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 10, 2021

Record last verified: 2021-02