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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 November 2023 |
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Main ID: |
NCT04452825 |
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Date of registration:
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26/06/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A New Psychotherapy Intervention for Older Cancer Patients
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Scientific title:
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Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer |
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Date of first enrolment:
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February 1, 2021 |
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Target sample size:
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296 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04452825 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Christian Nelson, PhD |
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Address:
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Telephone:
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646-888-0030 |
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Email:
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Affiliation:
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Name:
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Christian Nelson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan Kettering Cancer Center |
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Name:
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Christian Nelson, PhD |
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Address:
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Telephone:
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646-888-0030 |
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Email:
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nelsonc@mskcc.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- As per self-report or medical record, = 70 years of age
- As per self-report or medical record, has a diagnosis of cancer
- As per self-report or medical record, receiving active treatment (e.g., radiation,
chemotherapy, hormone); OR received active treatment in the past 6 months (N/A for
training case participants); OR are currently on active surveillance with follow-ups
at least approximately every 6 months
- Received a HADS-D score of = 6 or HADS-A score of = 6 or a score of = 4 on the
distress thermometer. (N/A for training case participants)
- Received a Karnofsky Performance Rating Scale (KPRS) score of = 60 (N/A for training
case participants)
- Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of = 11 (N/A
for training case participants)
- Fluent in English, as per self-reported fluency of "well" or "very well"*
Exclusion Criteria:
- As per self-report, currently taking antidepressant medication for < 3 months
- As per self-report, currently receiving hospice care
- In the judgment of the consenting professional is unable to provide informed consent
and complete study sessions and assessment
- As per self-report or as documented in the medical record, current untreated (e.g., no
medication, no therapy) major psychotic disorder (schizotypal personality disorder,
schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major
psychiatric disorder will be reviewed by the study PI to determine eligibility prior
to consent.
- Language verification: Prior to enrollment, patients will be asked the following
two questions by research staff to verify English fluency necessary for
participation in the study:
1. How well do you speak English? (must respond "Well" or "Very well" when
given the choices of Very well, Well, Not well, Not at all, Don't know, or
Refused)
2. What is your preferred language for healthcare? (must respond English)
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Behavioral: Social Work and Supportive Counseling (SWSC) Intervention
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Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention
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Primary Outcome(s)
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Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)
[Time Frame: 9 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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