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NCT Number: NCT02174055

Identifying and Measuring Depression in Older Cancer Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

patient interviews

Behavioral

participate in a brief interview

newly developed questionnaire

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

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.

Primary outcomes

  1. develope psychometric assessment of a self report measure of depression

    Time frame: 2 years

    This protocol aims to design, develop and pilot test a psychometric assessment for depression in older cancer patients.

  2. identify differences in item endorsement between younger and older cancer patients on existing depression measures.

    Time frame: 1 year

    These participants will be asked to complete several existing depression measures.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Fordham University

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2014
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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