Identifying and Measuring Depression in Older Cancer Patients

Older Cancer Patients Clinical Trial

Official title:

Identifying and Measuring Depression in Older Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02174055
• Other study ID #: 14-101
• Status: Active, not recruiting
• Start date: June 20, 2014
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Older Cancer Patients

Intervention

Behavioral:
• Patient Interviews
participate in a brief interview
• newly 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.
• Pilot 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Fordham University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	develope psychometric assessment of a self report measure of depression	This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.	2 years
Primary	identify differences in item endorsement between younger and older cancer patients on existing depression measures.	These participants will be asked to complete several existing depression measures.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center