Clinical trial NCT02174055: Identifying and Measuring Depression in Older Cancer Patients
Official title: Identifying and Measuring Depression in Older Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Older Cancer Patients
Keywords: Depression
14-101
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Fordham University
First posted: 2014-06-25
Enrollment: 329
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For all Phases, patients who are identified as eligible will be approached in-person in the outpatient clinics or the MSK Counseling Center by members of the research staff, or by letter (physical or electronic).

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.


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).

Primary outcomes:
measure: develope psychometric assessment of a self report measure of depression
timeFrame: 2 years
measure: identify differences in item endorsement between younger and older cancer patients on existing depression measures.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: