NCT04452825 A New Psychotherapy Intervention for Older Cancer Patients
| NCT ID | NCT04452825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 459 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 459 participants in total. It began in 2021-02-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to see if a new psychotherapy intervention called Cancer and Aging: Reflections for Elders (CARE) can effectively treat depression and distress in older cancer patients. CARE is a 5-session intervention that takes place over the phone. This study will compare CARE with the Social Work and Supportive Counseling (SWSC) intervention, which also takes place over the phone. SWSC is a standard psychotherapeutic intervention that has been shown to be a supportive and effective form of treatment for distress for patients with cancer. The researchers will look at which intervention is more effective in treating depression and distress in participants.
Eligibility Criteria
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)
Contact & Investigator
William Breitbart, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04452825 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04452825 currently recruiting?
Yes, NCT04452825 is actively recruiting participants. Contact the research team at breitbaw@mskcc.org for enrollment information.
Where is the NCT04452825 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04452825 clinical trial?
NCT04452825 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is William Breitbart, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 459 participants.
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