Identifying and Measuring Depression in Older Cancer Patients

NCT ID: NCT02174055

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 329 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-20
• Study Completion Date: 2026-06-30

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.

Conditions

Older Cancer Patients

Study Design

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

Study Groups

Cancer Patients

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.

Patient Interviews

Intervention Type: BEHAVIORAL

participate in a brief interview

newly developed questionnaire

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

Patient Interviews

participate in a brief interview

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fordham University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

14-101

Identifier Type: -

Identifier Source: org_study_id