Predictive Value of the Distress Thermometer as a Predictive Screening Instrument to Detect Cancer-related Cognitive Impairment in Cancer Patients

NCT ID: NCT01846260

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed Description

Design: Prospective, observational study. All cancer patients of the above mentioned cancer types receiving an anticancer treatment with curative intent will be asked to participate to this study. Consenting patients will undergo serial assessment at baseline, and 6 months after inclusion. Patient will be screened by the Distress Thermometer and 38-item Problem List followed by a neuropsychological assessment and self-assessment tools.

Conditions

Cancer Patients Eligible for a Treatment With Curative Intent; Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital Groeninge

OTHER

Sponsor Role: lead

Responsible Party

Dr. Philip Debruyne

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip R Debruyne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Groeninge

Locations

General Hospital Groeninge

Kortrijk, , Belgium

Countries

Belgium

References

Lycke 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.

Reference Type: RESULT

PMID: 27338029 (View on PubMed)

Lycke 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.

Reference Type: RESULT

PMID: 28816636 (View on PubMed)

Other Identifiers

AZGS2013021

Identifier Type: -

Identifier Source: org_study_id