A New Psychotherapy Intervention for Older Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04452825
• Other study ID #: 20-191
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Christian Nelson, PhD
• Phone: 646-888-0030
• Email: nelsonc[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Cancer and Aging: Reflections for Elders (CARE) Intervention
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
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center