Clinical trial · Observational
Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cognitive impairment associated with chemotherapy is an important reported post-treatment side-effect among breast and other cancer survivors. As some patients report cognitive complaints before the administration of their therapy, some authors suggest an association with psychological risk factors such as distress. Distress, a multifactorial unpleasant emotional experience of a psychological (cognitive, behavioral and emotional), social and/or spiritual nature that may interfere with the ability to cope with cancer effectively, its physical symptoms and its treatment, can easily be assessed by the Distress Thermometer. In this trial we aim to determine if the Distress Thermometer, accompanied by the 38-item Problem List, could predict cancer-related cognitive impairment in patients with hematologic malignancies, and in patients with gynecological, urological, breast, lung or gastro-intestinal cancer receiving curative radiotherapy, chemotherapy, radiochemotherapy, anti-hormonal or targeted therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients Eligible for a Treatment With Curative Intent | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validation of the Distress Thermometer, accompanied by the 38-item Problem List, as a screening tool to predict cancer-related cognitive impairment, measured through standard neuropsychological testing
- timeFrame
- 6 months
- description
- The primary objective of this observational study is to validate the Distress Thermometer, accompanied by the 38-item Problem List, as a screening tool to predict cancer-related cognitive impairment, measured through standard neuropsychological testing in cancer patients receiving curative (adjuvant) radiotherapy, chemotherapy, radiochemotherapy, radiobiotherapy, or targeted therapy.
Secondary outcomes (5)
- measure
- Prevalence of cognitive impairments and distress in all cancer patients included in this study and per cohort in a general hospital in Belgium by use of the Distress Thermometer and neuropsychological assessment
- timeFrame
- 6 months
- measure
- Comparison of subjective patient reported symptoms through self-reported measurements with objective neurocognitive test results and to examine the feasibility of these self-report assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients should have reached a minimum age of 18 years at the time of enrolment * Newly detected histologically confirmed diagnosis of a solid (lung, gastro-intestinal, GIST, urological, prostate, breast, sarcoma or gynecological cancer) or hematologic malignancy * Patients should receive a treatment with curative intent based on the investigator's judgment or have an expected median overall survival of at least 5 years * Patients scheduled to receive (adjuvant) radiotherapy, chemotherapy, radiobiotherapy, radiochemotherapy, anti-hormonal or targeted therapy with curative intent * Patients should be able to adequately communicate in Dutch * Patients should present with a sufficient mental and physical functional status (according to investigator's judgment and first baseline assessment) for completing the questionnaires and neuropsychological assessment Exclusion Criteria: * Patients younger than 18 at the time of enrollment * Patients who present with a cognitive impairment * Patient receiving a treatment with palliative intent * Patients who had surgery in the three weeks preceding the baseline assessment * Patients diagnosed with primary or secondary brain tumors * Patients with a prior history of cancer during the last 5 years, with or without chemotherapy or radiotherapy * Patients suffering from organic brain disease * Patients with an untreated or unstable major medical condition * Patients who are alcohol or drug dependent * Patients showing signs of mental deterioration * Patients with dementia (DSM-IV criteria) * Patients with a major psychiatric or neurologic disorder that could potentially invalidate assessment; a prior or current diagnosis of a depressive or anxiety disorder is allowed * Patients presenting with a condition other than cancer in which fatigue is a prominent symptom (such as chronic fatigue symptom)
References
Publications (2)
- RESULTLycke M, Pottel L, Pottel H, Ketelaars L, Stellamans K, Van Eygen K, Vergauwe P, Werbrouck P, Goethals L, Schofield P, Boterberg T, Debruyne PR. Predictors of baseline cancer-related cognitive impairment in cancer patients scheduled for a curative treatment. Psychooncology. 2017 May;26(5):632-639. doi: 10.1002/pon.4200. Epub 2016 Aug 1. PMID 27338029
- RESULTLycke M, Lefebvre T, Pottel L, Pottel H, Ketelaars L, Stellamans K, Eygen KV, Vergauwe P, Werbrouck P, Goethals L, Schofield P, Boterberg T, Debruyne PR. The distress thermometer predicts subjective, but not objective, cognitive complaints six months after treatment initiation in cancer patients. J Psychosoc Oncol. 2017 Nov-Dec;35(6):741-757. doi: 10.1080/07347332.2017.1365798. Epub 2017 Aug 17. PMID 28816636