Clinical trial NCT04749056: Electronic Psycho-oncological Adaptive Screening Program
Official title: Evaluation of an Electronic Psycho-oncological Adaptive Screening Program to Assess Psychological Burden and Need for Psycho-social Support Among Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
name: University of Leipzig
First posted: 2021-02-10
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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 in turn have multiple limitations: To be effective in reducing distress, screening results need to be adequately interpreted and transformed into individualized support plans. Most of current screening programs expect the clinical staff to undertake this task, which in turn requires extensive and repeated training. Another critical issue is the assessment: To limit the completion time to a minimum, conventional screening instruments contain as few items as possible, which in turn limits their diagnostic accuracy. Finally, most screening programs assume that there is a clear link between reported levels of distress and the individual need for psychosocial care. Accordingly, many current screenings derive the need for psychosocial care exclusively from the level of distress reported by the patients. However, self-reported distress and self-reported supportive care need are not closely related.

Aims of the study: 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.

Sample size: Our study aims to separately test for group differences (screening vs. no screening) at t1 and t2. To detect an expected small to medium group difference in level of information (effect size = 0.3) with a power of 80 %, sample sizes of 176 patients in each group were needed. Given an expected drop-out rate of 30 % from t0 to t2, we initially planned to recruit n = 251 per group (ntotal = 502).

Recruitment: Patients are recruited within suitable health care facilities within the University Cancer Center Hamburg (UCCH) and 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.

Sample: We applied a cross-over design: That is, all clusters received each intervention so that a largely equal number of patients received each intervention in each cluster. Between the changes of the conditions, recruitment was suspended for a certain amount of time to avoid any overlap of patients in the two conditions.

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 separately for t1 and t2. Robustness of the analyses is checked by calculating both unconditional and conditional (controlled for care relevant co-variates) models. In detail, we apply linear and logistic regression analyses for continous and binary outcomes, respectively.

Detailed description of the intervention:

General principle and procedure: The patients in the intervention arm 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 UCCH. 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 (see algorithm section). 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 including the conventional tests that are also assessed by the control group takes about 30 minutes.

Measures within EPAS: Three adaptive tests with varying response options are applied to assess depression (D-CAT, 64 items), anxiety (A-CAT, 50 items) and distress/stress reaction (S-CAT, 38/31 items). From the item pools, only items with highest information value are selected according to both item characteristics and individual response pattern. The presentation of items ends if (i) the standard error was ≤ 0.32 or (ii) a maximum of 10 items is reached. Furthermore, patients fill in an internally developed checklist to report supportive care needs.

Structure and content of the results page: 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 UCCH based on the care needs. As additional information to interpret the levels of distress, categories derived from a psychosomatic population are provided for D-CAT and A-CAT (low/medium/high). No such categories exist for the S-CAT, and thus the mean among a population with burnout-syndrome is provided as a reference value. The patient and physician versions slightly differ: Whereas patients are explicitly referred to the information brochure they receive during the screening, the distress-categories in the physician version are illustrated with colors (low = green; medium = yellow; high = red) and contain specific information in case of highly distressed patients (see algorithm section).

Algorithm for the results page: The supportive care needs reported in the respective list are transformed into concrete recommendations to use the adequate psychosocial service at the UCCH (e.g., a reported need for support to return to work results in a recommendation to use the social service). Highly distressed patients, i.e., those falling in the category "high" in the A-CAT or D-CAT, are recommended to use psycho-oncological service irrespective of whether they have previously 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 (e.g., check for medical reasons for distress, encourage patients to use psycho-oncological service).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Information level about psychosocial services at 3 months-follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Information level about psychosocial services at 6 months-follow-up
timeFrame: The outcome is assessed at T2 (six months follow-up).
measure: Use of the psychosocial services at 3-months follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Use of the psychosocial services at 6-months follow-up
timeFrame: The outcome is assessed at T2 (six months follow-up).
measure: Evaluation of access to psychosocial services
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Depressive symptomatology at 3-months follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Depressive symptomatology at 6-months follow-up
timeFrame: The outcome is assessed at T2 (six months follow-up).
measure: Anxious symptomatology at 3-months follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Anxious symptomatology at 6-months follow-up
timeFrame: The outcome is assessed at T2 (6-months follow-up).
measure: Health-related quality of life at 3-months follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Health-related quality of life at 6-months follow-up
timeFrame: The outcome is assessed at T2 (6-months follow-up).
measure: Treatment satisfaction at 3-months follow-up
timeFrame: The outcome is assessed at T1 (3-months follow-up).
measure: Treatment satisfaction at 6-months follow-up
timeFrame: The outcome is assessed at T2 (6-months follow-up).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Leipzig
name: Anja Mehnert-Theuerkauf, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.