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

NCT ID: NCT07218250

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-10-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SSC-C - Single Session Consultation for Cancer

will receive the study counseling

Group Type EXPERIMENTAL

Single Counseling Session

Intervention Type BEHAVIORAL

The one-time counseling session will be a problem-solving focused program that will try to strengthen the belief in the ability to manage the challenges of the cancer diagnosis and treatment

PPSB - Psychosocial Patient Support Booklet

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

Group Type ACTIVE_COMPARATOR

American Cancer Society booklet

Intervention Type OTHER

called "After Diagnosis: A Guide for Patients and Families" for review. Again, this booklet includes information about cancer, living with cancer, making treatment decisions, talking to others about cancer, cancer treatment, and questions for the cancer care team. It will be given in person or by email.

Interventions

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Single Counseling Session

The one-time counseling session will be a problem-solving focused program that will try to strengthen the belief in the ability to manage the challenges of the cancer diagnosis and treatment

Intervention Type BEHAVIORAL

American Cancer Society booklet

called "After Diagnosis: A Guide for Patients and Families" for review. Again, this booklet includes information about cancer, living with cancer, making treatment decisions, talking to others about cancer, cancer treatment, and questions for the cancer care team. It will be given in person or by email.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The City College of New York

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devika Jutagir, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Devika Jutagir, PhD

Role: CONTACT

646-888-8361

Francesca Gany, MD, MS

Role: CONTACT

646-888-8054

Facility Contacts

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Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Devika Jutagir, PhD

Role: primary

646-888-8361

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-281

Identifier Type: -

Identifier Source: org_study_id

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