Leitlinienprogramm OnkologiePsycho-oncology

7. Diagnostics – Psycho-oncology

Version 2.0 · May 2023 · AWMF 032-051OL
Leitlinienprogramm Onkologie · Deutsche Krebsgesellschaft · Deutsche Krebshilfe · AWMF

7.1 Tasks and Special Features

Psycho-oncology is based on a biopsychosocial model of disease and health. This means that biological, psychological and social factors determine the development of diseases and that diseases can in turn affect biological, psychological and social factors [459].

In this context, the overlapping of physical symptoms of mental disorders with disease- or therapy-related symptoms is distinctive for the diagnosis of mental disorders in cancer patients, and thus makes a careful differential diagnosis necessary.

Primary tasks of diagnosis in cancer patients include the identification of psychosocial stress, mental disorders and other problems with the aim of describing existing problems and disorders as well as changes in symptoms; the classification of existing problems and disorders into diagnostic categories of a classification system (ICD-10); the provision of diagnostic information for the indication of psycho-oncological interventions and the evaluation of psycho-oncological interventions.

The diagnosis of a clinically relevant comorbid disorder requires differentiation from somatic complaints or an appropriate psychological response to cancer, as well as an appropriate consideration of biological-organic sequelae of the cancer or treatment [243], [390],[460], [461].

The diagnosis of specific problems such as unipolar depression, post-traumatic stress disorder, and trauma sequelae is explained in detail in the relevant guidelines (Table 9).

7.1.1 The Objective of Psycho-oncological Diagnostics

7.1 · Consensus-based Recommendation · checked 2023

The assessment of psychosocial distress and individual psycho-oncological support and treatment needs should occur as early as possible and then repeatedly during the course of the disease.

Consensus
Strong consensus (96%)

The primary objective of psycho-oncological diagnostics is the early recognition of psychological, family, and social distress; psychological and psychosomatic symptoms; and the processing of the disease, especially with regard to the effects of the cancer and treatment measures. In addition to the type of stress, the psycho-oncological diagnosis also determines its severity, the time of occurrence as well as the course of the distress. It also aims to assess individual and social resources and the quality of life as well as the subjective need for treatment and the motivation for treatment.

A diagnosis of mental health disorders and the assessment of psychopathological findings are generally useful, but, in addition to the internationally recognized criteria of the ICD/DSM classification, should always be based on the stage of the disease, the prognosis and the physical health of the cancer patient, and the available local care and treatment options.

The psycho-oncological diagnosis is the basis for the recommendation of psycho-oncological support measures. It takes place in a staged process beginning with distress screening and a more in-depth clarification depending on the results of the screening (see Chapter 7.4). Psycho-oncological diagnostics should be carried out as early as possible in the course of the disease, so that existing stressors can be identified early and a worsening of the symptoms can be prevented.

7.2 Screening

7.2 · Consensus-based Recommendation · modified 2023

All cancer patients shall be screened for psychosocial stress.

Consensus
Strong consensus (96%)
Change noteAll patients should be screened for psychosocial stress. Psycho-oncological screening should be performed as early as possible, at appropriate intervals, if clinically indicated, or repeatedly during the course of the disease if a patient's disease status changes (e.g., recurrence or progression of the disease).
7.3 · Consensus-based Recommendation · modified 2023

Psycho-oncological screening should be performed as early as possible, at appropriate intervals, during the course of the disease, when clinically indicated or if a patient's disease status changes (e.g., recurrence or progression of the disease).

Consensus
Strong consensus (96%)
Change noteAll patients should receive screening for psychosocial distress. Psycho-oncological screening should be performed as early as possible at appropriate intervals, when clinically indicated, or repeatedly during the course of the disease if there is a change in a patient's disease status (e.g., recurrence or progression of the disease).

A screening instrument (e.g., screening questionnaire) is defined as a means to identify a specific feature (e.g., psychological distress) in a large group of individuals. A screening for psychosocial distress and mental disorders indicates with a specific probability the absence or presence of distress, which should be further clarified through a clinical interview. Methods may include either self-description questionnaires or clinical screening questions.  

Most screening instruments for psychosocial stress and mental disorders are self-description questionnaires that gather psychological symptoms in an easy to understand language. The scoring of such a questionnaire is based on a certain limit or threshold value (cut-off value) which defines whether the sum of the given positive answers makes the presence of a mental disorder or psychosocial distress likely or not.

In any screening, individuals may be misclassified. In the context of psycho-oncology, this means that individuals are falsely identified as having a high level of psychosocial distress even though they do not present with a problem requiring treatment upon further assessment (false positives), or, individuals are highly distressed but are not detected by screening (false negatives). Sensitivity refers to the proportion of impacted individuals who are correctly identified by screening. High sensitivity means that only a few mentally distressed individuals are missed by the screening instrument (i.e., few false negatives). Specificity means the proportion of marginally or not at all distressed individuals who are correctly identified as marginally or not at all distressed by the screening. High specificity means that only a few healthy individuals are incorrectly classified as ill by the screening instrument (i.e., few false positives). The quality of a screening instrument is determined by the balance of sensitivity and specificity. A screening is more accurate the higher the percentage of individuals correctly classified by the screening instrument.

For the psycho-oncological diagnosis, there are a number of questionnaires available that screen to identify low-threshold patients with specific disorders or problems. Specific recommendations for suitable questionnaires are given in Chapter 7.3.1.

A psycho-oncological screening questionnaire can be implemented in all care settings, i.e. inpatient as well as outpatient care. A psycho-oncological screening questionnaire can be incorporated into the medical or nursing history alongside the psychosocial history [462], [463], [464], [465].

Clinical screening questions include „How distressed have you felt in the past week?“, „How much did you feel affected by nervousness, anxiety, or tension in the past two weeks?“ or „How much did you feel affected by feeling down and/or depressiveness in the past two weeks?“.

Screening for psychosocial distress can be performed by any member of the treatment team involved in the care of cancer patients after appropriate training, depending on the situation at the site. The professional groups involved in the treatment of cancer patients should be able to recognize the type and extent of psychosocial distress and, if necessary, initiate a specific diagnostic clarification by a specialist or psychotherapist. This also applies to the assessment of suicidal tendencies or other forms of danger to self or others by the patient.

The clinical diagnostic process includes the assessment of complaints and symptoms, findings and classification diagnostics, trait diagnostics, the analysis of living conditions (including the role of caregivers) as well as the planning and discussion of intervention services, patient information and, if necessary, clarification with respect to the patients’ motivation to change [466].

 

According to expert consensus, screening implemented as early as possible can prevent the chronification of psychological distress and is therefore of great importance in the diagnosis process. Empirical evidence is still lacking and should be supported by appropriate studies. It should therefore be carried out as part of the first contact with an outpatient or inpatient care facility. However, it must be taken into account that the screening should not be stressful for the patient. In rare cases, patients refuse screening due to the fear of being stigmatized.

Screening for psychosocial distress and determination of support needs should be voluntary. Information and support options based on the criteria of participatory decision-making should be discussed with the patient.

7.3 Diagnostic Procedures

7.3.1 Appropriate Screening Methods for Assessing the Need for Psycho-oncological Intervention

7.4 · Evidence-based Recommendation · modified 2023

Validated and standardized screening instruments shall be used to assess psychosocial distress.

The screening instruments that shall be used are the Distress Thermometer (DT), the Hospital Anxiety and Depression Scale (HADS), the Questionnaire on Distress in Cancer Patients (FBK), the Depression Module of the Patient Health Questionnaire (PHQ-9), or the Generalizied Anxiety Disorder Scale-7 (GAD-7).

Recommendation grade
A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
Level of evidence
1b
Consensus
Consent (87%)
References
[467] [468] [469] [470] [471] [472] [473] [474] [475] [476] [477] [478] [479] [480] [336] [481] [482] [339] [483] [484] [485] [486]
Change noteEC: Validated and standardized screening instruments should be used to assess psychosocial stress. The distress thermometer or the HADS-D are recommended as screening instruments. In addition, individual psychosocial support needs should be assessed.
7.5 · Consensus-based Recommendation · new 2023

In addition to the distress screening, the subjective need for psychosocial support shall also be asked.

Consensus
Consent (92%)
7.6 · Consensus-based Recommendation · checked 2023

If the screening is positive and/or there is a subjective need for support identified, a diagnostic interview shall be offered to clarify psychosocial distress, psychiatric comorbidity, as well as the need for support and treatment.

Consensus
Consent (90%)
7.7 · Consensus-based Recommendation · checked 2023

Further diagnostic clarification should be carried out according to individual psychological/social/somatic problems identified during the interview.

Consensus
Strong consensus (100%)

In the context of psycho-oncological diagnostics, only diagnostic procedures that fulfill the psychometric quality criteria (objectivity, reliability and validity) should be implemented. Practicability, even for patients with severe cancer, as well as cost-effectiveness are further important prerequisites. In addition to the aforementioned quality criteria, there should be empirically determined limits or threshold values (cut-off values) established for screening procedures, that also ensure satisfactory sensitivity and specificity.

The following criteria were defined for the selection of a screening instrument:

It measures psychosocial distress. Based on the definition of the NCCN (National Comprehensive Cancer Network), psychosocial distress is defined as „a broad spectrum of unpleasant emotional experiences of a psychological, social, or spiritual nature that can range from normal feelings of vulnerability, sadness, and anxiety to severely limiting problems such as depressiveness, anxiety disorders, panic, social isolation, and spiritual crises.“

Psychosocial distress is assessed across all types of cancers, meaning that the instrument can be implemented for all tumor entities in adult patients.

The psychometric quality criteria of practicability, objectivity, reliability and validity, which have been demonstrated in validation studies of cancer patients in Germany, are fulfilled.

There are empirically determined threshold values (cut-off values) for the identification of patients with significant psychological distress, thus ensuring satisfactory sensitivity and specificity [465].

On the basis of these selection criteria, the psychometric parameters for the following screening methods were tested (see table Psychometric Criteria of the Screening Instruments):

Based on a systematic literature review (see guideline report), the psychometric quality criteria and evidence levels for the screening questionnaires were determined. As part of the update of this guideline, the publications pertaining to German patients (n=22) were subjected to a systematic analysis. The results of this analysis are the basis of recommendation 7.4. The corresponding  evidence table can be found in the Guideline Report.

Table 4: Psychometric Criteria of the Screening Instruments

Instrument

Reliability

 

Validity

 

 

Sensitivity/Specificity

 

Cut-off Score(s)

To be filled in by the patient

Cut-off value must be calculated  

 

Evidence level**

 
 

DE*

INT†

DE*

INT

DE*

INT

      

DE 

INT

HADS-D

+

+

+ 

+

+

+

yes
0-7: normal

8-10: borderline

11-21:  moderate to severe

yes

yes

1b 

1b 

HSI‡

+

-

+

-

+

-

yes
(determined by discriminant function
) 

yes

yes

2b

-

DT

+

+ 

+ 

+

+

+

yes
0-4: normal
5-10: high

yes

no

1b

1b

FBK

+

-

+

-

+

-

yes
at least 2 x 5 or
at least 1 x 5 plus
at least 4 x 4 or
at least 5 x 4 or
at least 1 x 5 plus 
at least 3 x 4 plus item 22 ≥ 1

yes

 

yes

 

1b

 

-

 

PO-Bado

+

-

+

-

+

-

yes
at least 1 x 4 or
at least 2 x 3 or

2 additional items or at least 1 x 3 plus 1 additional item

no

yes

2b

-

PHQ

+

+

+

+

+

+

yes
0-4: low
5-9: mild expression
10-14: moderate expression 
15-27: severe expression 

yes

yes

1b

1b

GAD-7

+

+

+

+

+

+

yes 
0-4: low
5-9: mild expression 
10-14: moderate expression 
15-21: severe expression 

yes

yes

1b

1b

HADS-D: Hospital Anxiety and Depression Scale, HSI: Hornheider Screening Instrument, DT: Distress Thermometer, FBK: Questionnaire on Distress in Cancer Patients (FBK-23 and FBK-10), PO-Bado: Basic psycho-oncology Documentation (PO-Bado, PO-Bado KF and PO-Bado breast cancer), PHQ: Health Questionnaire for Patients – Depression Module (PHQ-4 and PHQ-9), GAD-7: Health Questionnaire for Patients – Generalized Anxiety Disorder Module, * Studies conducted in Germany, ** Determination of evidence level according to Centre for Evidence Based Medicine (CEBM) (Oxford), † International studies, ‡ Interview version available, + proven, - not proven

The best evidence is available nationally and internationally regarding cancer patients is provided by the Hospital Anxiety and Depression Scale (HADS-D), the Distress Thermometer (DT), the Depression Module of the Patient Health Questionnaire (PHQ-9), and the Generalized Anxiety Disorder (GAD-7) Module. In German-speaking regions, the Questionnaire on Distress in Cancer Patients (FBK-23 and FBK-10) continues to be well validated.

Among the other screening instruments, the PO-Bado (PO-Bado, PO-Bado KF, and PO-Bado Breast Cancer) as an independent assessment tool continues to have good evidence base in cancer patients with regard to the psychometric quality criteria. The Hornheider Screening Instrument (HSI) has good psychometric parameters, but has only been validated in patients with skin cancer.

If psychosocial distress has already been identified through a discussion with the patient, then no additional screening is required, rather, a clinical diagnosis is promptly established (or the recommendation and, if necessary, referral to the relevant psychosocial professional groups).

 

Psycho-oncological diagnostics

A comprehensive psycho-oncological diagnosis may include multiple approaches (self and external assessment) and important reference partners (family members, members of the health care team). Clinical interviews are part of a comprehensive psychosocial diagnosis and the most valid method for assessing a mental disorder. Common clinical interviews include the Structured Clinical Interview for DSM-5 and the Composite International Diagnostic Interview based on ICD-10 and ICD-11, respectively. Most screening instruments are not available for free and must be purchased from the publishers. The PHQ-9 and the GAD-7 are available on the web. The Distress Thermometer can be found in the article on the German version of the NCCN Distress Thermometer by Mehnert and colleagues [477]. A concise compilation of screening methods can be found in the brochure on Screening Methods in Psycho-oncology, published by the German Cancer Society [575].

In the context of the diagnosis, the potential interactions between somatic or treatment-related symptoms and the occurrence of psychosocial distress and psychological disorders should be emphasized. Thus, the management and interpretation of somatic symptoms often poses a difficult problem in the diagnosis of mental disorders in patients with severe physical illness. The diagnostic clarification of physical, cancer-related and treatment-related factors contributing to and perpetuating psychosocial stress and mental disorders is therefore of great importance. Cancer patients may experience individual distress in response to the diagnosis and treatment of cancer (e.g., uncertainty about the course of the disease, family conflicts), due to treatment-related factors (e.g., inadequate pain management), as well as due to specific medications that increase the incidence of psychological distress (e.g., corticosteroids or certain cytostatic drugs), or due to withdrawal symptoms (e.g., opiate, benzodiazepine withdrawal). In addition, psychosocial distress and psychological disorders may already exist prior to the cancer diagnosis and may worsen during the course of treatment [576].

The documentation of disease sequelae should be based on the International Classification of Functioning, Disability and Health (ICF) of the WHO [577] and focus particularly on the limitations of activity in everyday life and social participation. For specific questioning, for example, in the area of cognitive impairments and psychomotorfunction, neuropsychological test procedures (e.g., TAP) can be recommended [462], [464], [578], [579], [580].

7.4 Diagnostic Process Steps

Psycho-oncological diagnosis is the essential basis for the recommendation of psycho-oncological support measures. It should be carried out as early as possible in the course of the disease, so that existing stressors can be identified early on, and a worsening of the symptoms can be prevented. It should be carried out in a stepwise process using a psycho-oncological screening that takes all patients into account and is also based on a clinical care algorithm (see Figure 2). Patients who obtain a significant value (screening cut-off value: positive) by means of a screening instrument (questionnaire or clinical assessment via screening questions) should receive more in-depth diagnostics, information, counseling and support. The need for treatment and the readiness for treatment should be further clarified in an initial interview, usually in the context of an anamnestic interview, if necessary with the aid of various diagnostic procedures. Patients with high psychosocial distress should be given access to psychosocial support services. The extent of which these services are taken advantage of should be evaluated. 

Patients identified by a screening instrument with an under threshold value (screening cut-off value: under threshold) should be informed about psychosocial support services (see Figure 2). Since a screening instrument does not provide one hundred percent detection, it should be possible to identify both false positive and false negative cases according to the clinical care algorithm. In the case of false positive cases, further care is provided in the framework of information and counseling. False negative cases should be identified in the scope of personal counseling and information and then further diagnosed for subsequent treatment planning.

In addition to this initial psycho-oncological diagnosis, a re-evaluation of the diagnosis should be implemented during the course of the illness (at the end of treatment or with changes in the clinical status of the disease, such as recurrence or progression). If there is a change of care setting (inpatient, outpatient, and rehabilitation), the psycho-oncological findings should be updated. An assessment of the diagnosis at the end of a psycho-oncological intervention provides evidence of the success of the intervention [581], [578], [465].

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