A New Psychotherapy Intervention for Older Cancer Patients

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

NCT04452825

20-191

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)

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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