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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07218250
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-15
• Study First Submitted: 2025-10-15
• Study First Submitted QC: 2025-10-15
• Last Update Submitted: 2025-10-15
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability (SSC-C participants)	up to 3 months	Participants will complete a satisfaction survey after completing the SSC-C intervention. A 5-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participant found SSC-C helpful in developing an action plan to address their concerns, their perceived utility of the action plan, the degree with which they believe they will use the action plan, their motivation to do so, and the extent to which they will recommend SSC-C to other patients.
Acceptability (PPSB participants)	up to 3 months	Participants will complete a satisfaction survey after receiving PPSB intervention materials. A 6-item, investigator- initiated, face-valid satisfaction survey will assess the degree with which participants found PPSB intervention helpful in developing an action plan to address their concerns, their perceived utility of the booklet, the degree with which they believe they will use the booklet, their motivation to do so, and the extent to which they will recommend the booklet materials to other patients.

Secondary Outcome Measures

Name	Time	Method
Psychosocial distress	up to 3 months	The Hospital Anxiety and Depression Scale (HADS) will assess symptoms of anxiety (7 items, range 0-21) and depression (7 items, range 0-21).

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only); 🇺🇸 Uniondale, New York, United States