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NCT Number: NCT04452825

A New Psychotherapy Intervention for Older Cancer Patients

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.

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Key information

Conditions

Cancer Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Rebecca Saracino, PhD

CONTACT

646-888-0263

William Breitbart, MD

CONTACT

646-888-0030

Who can participate

Healthy volunteers accepted: No

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

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:
  • 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)
  • What is your preferred language for healthcare? (must respond English)

Treatment and study plan

Cancer and Aging: Reflections for Elders (CARE) Intervention

Behavioral

For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).

Social Work and Supportive Counseling (SWSC) Intervention

Behavioral

The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months). Training case participants will follow a slightly condensed schedule.

Primary outcomes

  1. Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS)

    Time frame: 9 months

    This 14-item scale, which has been well tested in cancer populations including elderly patients with cancer, has depression and anxiety subscales of seven items each. It is considered particularly useful for patients with chronic disease because of the absence of somatic items that often confound the determination of psychiatric problems among the medically ill.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Saracino, PhD

CONTACT

[email protected]

646-888-0263

William Breitbart, MD

CONTACT

[email protected]

646-888-0020

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Cancer and Aging Reflections for Elders (CARE): A Geriatric-Specific Psychotherapy for Older Adults With Cancer

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Apr 17, 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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