A New Psychotherapy Intervention for Older Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

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


Participation Criteria
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Eligibility 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: 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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is designed to test CARE delivered by telephone to improve cancer care for the population of older adults in a larger two-arm Randomized Controlled Trial (RCT).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer and Aging: Reflections for Elders (CARE) Intervention<br>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). | Behavioral: Cancer and Aging: Reflections for Elders (CARE) Intervention<br>* 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).<br>|
| Experimental: Social Work and Supportive Counseling (SWSC)<br>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). | Behavioral: Social Work and Supportive Counseling (SWSC) Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and Anxiety: Hospital Anxiety and Depression Scale (HADS) | 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. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric cancer, geriatric specific, older adults with cancer, Psychotherapy, Memorial Sloan Kettering Cancer Center, 20-191