A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Single Counseling Session; Other: American Cancer Society booklet

Study type: Interventional

Funder types: Other

Identifiers

NCT07218250

25-281

Details and patient eligibility

About

The purpose of this study is to see if a Single Counseling Session for Cancer can help reduce psychosocial distress and improve quality of life in people with breast cancer who are waiting to receive ongoing counseling services (outpatient psychotherapy services). The Single Counseling Session for Cancer-which I will refer to as the "study counseling" during this call-is a one-session, 60-minute counseling program designed to reduce anxiety and depression symptoms in people with cancer who are waiting to receive outpatient psychotherapy services. The researchers will look at whether the study counseling is effective in participants and practical (feasible) for them to complete.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient must have pathologically confirmed breast cancer (per EMR).
• Patient with localized or advanced cancer (per EMR).
• Patient is on a waitlist of at least 2 weeks or more for MSK Counseling Center intake and will not complete a Counseling Center intake prior to intervention (these patients will be replaced) (per EMR, patient's care team, or self-report).
• Has no current active or passive suicidal ideation (per self-report of PHQ-9, Item 9: Thoughts that you would be better off dead, or of hurting yourself).
• Female (per EMR)
• Age ≥ 18 (per EMR)
• English fluency - Per self-report: How well do you speak English?
• Agrees to be audio-recorded (per self-report) NOTE: Participants who report Very well are considered fluent.
• Lives in New York, New Jersey, or Connecticut (per self-report).
• Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require urgent or extended individual treatment) (per EMR, patient's care team, or study team).
• Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, or per self-report of BOMC cognitive test).
• Has no current active or passive suicidal ideation (per item 9 of the PHQ-9 and the CSSRS).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SSC-C - Single Session Consultation for Cancer

Experimental group

Description:

will receive the study counseling

Treatment:

Behavioral: Single Counseling Session

PPSB - Psychosocial Patient Support Booklet

Active Comparator group

Description:

will receive an American Cancer Society booklet for review (and no counseling)

Treatment:

Other: American Cancer Society booklet