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Identifying and Measuring Depression in Older Cancer Patients

Identifying and Measuring Depression in Older Cancer Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02174055
Enrollment
329
Registered
2014-06-25
Start date
2014-06-20
Completion date
2027-06-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Older Cancer Patients

Keywords

Depression, 14-101

Brief summary

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.

Interventions

participate in a brief interview

BEHAVIORALnewly developed questionnaire

10-16 patients will review draft items and participate in a cognitive interview. 15 older patients will complete the draft measure in order to generate preliminary psychometric data. All interviews will be audio recorded and transcribed by Ubiqus Transcription Company. The audio recordings are uploaded through Ubiqus's secure server and the transcribed audio is returned to the research staff within 48 hours.

BEHAVIORALPilot Testing the Draft Measure

The draft measure (approximately 35 items, described above) will be administered to a large sample of older cancer patients (n=150) to generate data to evaluate preliminary psychometric properties (item properties including measures of central tendency, skewness/kurtosis, internal consistency, test/re-test reliability, and construct validity (i.e, convergent and discriminant).and known group differences) to further winnow the measure to include approximately 20 items.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
Fordham University
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
develope psychometric assessment of a self report measure of depression2 yearsThis protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.
identify differences in item endorsement between younger and older cancer patients on existing depression measures.1 yearThese participants will be asked to complete several existing depression measures.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRebecca Saracino, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026