Identifying and Measuring Depression in Older Cancer Patients

Active, not recruiting

• Conditions: Older Cancer Patients
• Interventions: Behavioral: Patient Interviews; Behavioral: newly developed questionnaire; Behavioral: Pilot Testing the Draft Measure

• Registration Number: NCT02174055
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-20
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 329

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Patients	newly developed questionnaire	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.
Cancer Patients	Pilot Testing the Draft Measure	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.
Cancer Patients	Patient Interviews	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.

Primary Outcome Measures

Name	Time	Method
develope psychometric assessment of a self report measure of depression	2 years	This 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 year	These participants will be asked to complete several existing depression measures.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States