Assessing Psychosocial and Supportive Care Needs in Patients With Gliomas
Condition: Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      The study is undertaken at three German neurosurgical centers (Ulm, Mainz, Stuttgart) between
      March 2014 and March 2015. Inclusion criteria were age ≥ 18 and ≤ 80, diagnosis of glioma
      WHO° II-IV, absence of aphasia impairing communication or consent. In an outpatient setting
      all eligible patients with gliomas were screened for distress (Distress Thermometer (DT)) and
      their need for psychosocial support (Supportive Care Needs Survey-SF34-G (SCNS)).
      Simultaneously their HRQoL was assessed (EORTC QLQ-C30+BN-20 Vers. 3).

      Patients at different disease stages were asked to fill out the questionnaires. At two study
      centers patients were asked to complete the questionnaires prior to their appointment with
      personal instructions in randomly selected cases. At the third study center, they completed
      the questionnaires after their outpatient appointment with personal aid and instructions. At
      the time of investigation, patients were at different stages of treatment (chemotherapy,
      radiation, re-chemotherapy, re-radiation, none, etc.).
    

Detailed description: 
      Study design

      In three neuro-oncological outpatient departments of the three study centers (two of them are
      university medical centers, one a teaching hospital), glioma patients were assessed between
      March 2014 and March 2015 using three questionnaires. Due to the infrastructure of the
      outpatient departments, assessing ment of supportive care needs, HRQoL, and distress, by the
      questionnaires was performed either with the opportunity of personal support by the study
      members (group A) or by patients alone (group B).

      In group A, a member of the study group (no caregivers) offered help and stayed with the
      patient the whole time while the patient was filling in the questionnaires. Every patient
      received an explanation and was offered additional support. If questions occurred or the
      patient was not able to fill in the questionnaires by him-/herself, the study member helped
      by answering questions, assisting or describing the questionnaires in detail or even reading
      out the questions to the patient and filling in the answers which were chosen by the patient.
      The extent of the assistance by the study members varied depending on the impairment of the
      patient. Occurrence and details of difficulties in completion were assessed by a feedback
      form especially developed for this study which was filled in by the member of the study group
      after completing the instruments. If patients were unable to complete the questionnaires by
      themselves, the reason for this was documented by the interviewer (e.g. neurocognitive
      impairment, physical disability, decreased attention span, etc. based and categorized on
      clinical judgement of the interviewer).

      In group B, patients completed the questionnaires on their own. In one study center,
      Allocation to study groups was randomized in one study center (block randomization
      independently provided by Institute of Medical Biostatistics, Mainz). Patients in the other
      two centers were either always group A or always group B.

      Furthermore, socio-demographic data, tumor stage, Karnofsky Performance Status (KPS), pre-and
      postsurgical clinical characteristics (e.g. postoperative tumor remnant, localization of the
      tumor), and adjuvant therapies were documented.

      The study was undertaken in concordance with national law, institutional ethical standards
      and the Helsinki Declaration, and the ethic commissions of all three study centers approved
      the study.

      Patient population

      Selection criteria for this study were:

        1. a glial cerebral tumor (astrocytoma, oligoastrocytoma, oligodendroglioma, glioblastoma),
           as diagnosed by the local neuro- pathologist in the study center;

        2. patient is affiliated with the neuro-oncological outpatient center in one of the three
           study centers;

        3. patient is able to understand and respond to the questions;

        4. informed consent of the patient.

      PRO Questionnaires

      For the first assessment, the SCNS-SF34-G, Distress Thermometer (DT), EORTC -QLQ- C30 + EORTC
      QLQ-BN20 and were used, for the second assessment after 3-5 months the SCNS-ST9, DT, and
      EORTC-QLQ-C30 + EORTC QLQ-BN-20 were used.

      The SCNS-SF34, a short-form version of the SCNS long-form, is a self-reporting instrument
      measuring patients' needs of supportive care. It consists of five domains: health system and
      information, psychological, physical and daily living, patient care and support, and
      sexuality needs. Lehmann et al. demonstrated adequate psychometric properties in the German
      version. On a 5-point Likert scale, patients indicate if they are in need of support and, if
      so, the extent of their need (1 = no need, not applicable; 2 = no need, satisfied; 3 = low
      need; 4 = moderate need; 5 = high need).

      The SCNS-SF9 is an ultrashort screening instrument developed of the SCNS-SF34 consisting of
      nine questions. The structure of the screening instruments is similar to the SCNS-SF34-G with
      the same 5-point Likert scale as described.

      The EORTC QLQ-C30 is a frequently used questionnaire including 30 items to assess quality of
      life in oncological patients and includes five functional scores (physical, role, emotional,
      social, and cognitive function). The reliability and validity of the instrument have been
      approved in many clinical trials, and it has been translated into 85 languages. The brain
      module (QLQ-BN20) comprises 20 questions developed for brain tumor patients and includes four
      functional scales.

      The Distress Thermometer (DT), a self-reporting instrument, evaluates psychological distress
      using a visual analogue scale along with 40 items assessing financial, physical, emotional
      and spiritual concerns (problem list). Developed by the National Comprehensive Cancer Network
      (NCCN), the German version was adapted in 2007. A score of six or above on the visual
      analogue scale is recommended as a cut-off for a clinically significant level of distress for
      brain tumor patients. The DT is well accepted for in oncological patients.

      Endpoints

      The primary evaluation of feasibility of the questionnaires in clinical routine was analyzed
      by analyzing the occurrence of missing values and the occurrence of errors in the SCNS-SF34-G
      and SCNS-ST9. Missing values were assessed in the categories single missing items (at least
      one item per questionnaire missing) and missing questionnaire (complete questionnaire was not
      filled in). An error was defined as multiple responses for an item where only one response
      per patient would have been correct. For both outcomes comparisons were made to the EORTC
      QLQ-C30+BN20 and DT as well as between groups A and B.

      The study members providing support for the patients of group A gave feasibility feedback
      regarding the difficulties occurred during the assessment after each patient using a 10-item
      feedback form developed for this study with the following items:

        -  Occurrence of difficulties (yes/no)

        -  Time needed for assessment (10-20min, 21-30min, 31-40min, 41-50 min, >51min)

        -  Impairment of the patients (none, cognitive, psychological, physical)

        -  If problems during the assessment occurred (none/rare/moderate/severe; defined by the
           frequency of questions asked by the patients)

        -  Which difficulties occurred (understanding questionnaire/complexity of
           questionnaire/extend of questions/physical problems e.g. paresis)

        -  Which questionnaire caused problems (EORTC/DT/SCNS)

        -  Which questionnaires were filled in with/without assistance

        -  Aid intensity level provided by the study members (assistance in one, two or all three
           questionnaires).

      Where possible these items were also analyzed in comparison to the other PRO instruments.

      Difficulties occurred in the SCNS were compared to the EORTC QLQ-C30+BN20 and DT whenever
      possible.
    

Intervention name(s): Missing items, Errors in Completion, Difficulties
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Selection criteria for this study were 1) a glial cerebral tumor (astrocytoma,
        oligoastrocytoma, oligodendroglioma, glioblastoma), as diagnosed by the local neuro-
        pathologist in the study center; 2) patient is affiliated with the neuro-oncological
        outpatient center in one of the three study centers; 3) patient is able to understand and
        respond to the questions; 4) informed consent of the patient.