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A New Psychotherapy Intervention for Older Cancer Patients

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Cancer

Treatments

Behavioral: Social Work and Supportive Counseling (SWSC) Intervention
Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

335 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

335 participants in 2 patient groups

Cancer and Aging: Reflections for Elders (CARE) Intervention
Experimental group
Description:
Session content and timing was developed and confirmed in our qualitative work (Expert Panel) and the CARE pilot study. 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).
Treatment:
Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention
Social Work and Supportive Counseling (SWSC)
Experimental group
Description:
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. 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).
Treatment:
Behavioral: Social Work and Supportive Counseling (SWSC) Intervention

Trial contacts and locations

1

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Central trial contact

Rebecca Saracino, PhD; Christian Nelson, PhD

Data sourced from clinicaltrials.gov

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