Clinical trial · Observational
Identifying and Measuring Depression in Older Cancer Patients
NCT02174055CI-TRIAL-00107536active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to develop an accurate and useful way of measuring older patients' moods and reactions to the combined issue of cancer treatment and aging. Also, the purpose of this study is to test a new self-report measure of depressive symptoms tailored to the needs of older adults with cancer. Findings from this research will help us develop improved methods of diagnosis and treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Older Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| newly developed questionnaire | Behavioral | — | UNRESOLVED |
| Patient Interviews | Behavioral | — | UNRESOLVED |
| Pilot Testing the Draft Measure | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer Patients
- description
- This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients. The study is divided in three phases. In Phase 1, approximately 15 depressed patients (as determined clinically) and approximately 15 non-depressed patients will undergo individual interviews. In Phase 2, the team will use the themes and subthemes obtained in Phase 1 to write a set of indicators into questionnaire form. In Phase 3, the newly developed questionnaire will be given to a sample of approximately 150 cancer patients who meet the eligibility criteria. Survey results obtained from this sample of 150 patients will be used to assess internal consistency, conduct item analysis, and determine the unique content of the proposed instrument.
- interventionNames
- Behavioral: Patient Interviews
- Behavioral: newly developed questionnaire
- Behavioral: Pilot Testing the Draft Measure
Primary outcomes (2)
- measure
- develope psychometric assessment of a self report measure of depression
- timeFrame
- 2 years
- description
- This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: For Patients in Phases 1- 3: * Current or previous cancer diagnosis and treatment (any site and any stage) * All Phases 1,2,3- 70 years of age or older * For Phase 1b only; 50 participants ages 50-69 will also be recruited * For Phase 2 only: As per medical record or self report, history of Depression, Dysthymia, or Adjustment Disorder with Depressed Mood * For Phase 3 depressive subset: As per medical record or self report, a history of depressive symptoms such as * Adjustment Disorder with depressed mood * Adjustment Disorder with mixed depressed mood and anxiety * Mood disorder (i.e., due to general medical condition, Not Otherwise Specified) * Depressive Disorder (i.e., Major Depressive Disorder (MDD) single episode, MDD recurrent, Depressive disorder not otherwise specified, Dysthymia) * In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English Exclusion Criteria: For Patients in Parts 1- 3: * In the judgment of the consenting professional and/or as per medical record, severe psychopathology or cognitive impairment likely to interfere with the participation or completion of the protocol or ability to provide meaningful information. * For Phase 1\&2 only: Score of \> 11 on the Blessed Orientation-Memory-Concentration Scale (BOMC) * For Part 2 only: As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, current substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, Attenuated Psychotic Disorder, and Adjustment Disorder (except for Adjustment Disorder with Depressed Mood).
References
Publications (0)
Data not yet available
No reference posted for this study.