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

Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Breast Cancer Patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07218250
Enrollment
26
Registered
2025-10-20
Start date
2026-06-04
Completion date
2027-06-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Counseling Session, Reduce Depression, Reduce Anxiety, Reduce Distress, 25-281

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.

Interventions

BEHAVIORALSingle 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

OTHERAmerican 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER
The City College of New York
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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 New Visit with a clinical psychologist prior to intervention (these patients will be replaced) (per EMR, patient's care team, or self-report) * Has not had and is not scheduled to have an appointment with an MSK psychiatrist or MSK Counseling Center advanced practice provider (per EMR, patient's care team, or self-report) * 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, Connecticut, or Florida (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, dementia, or traumatic brain injury) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, study team, or per self-report of BOMC cognitive test). * Has no current active or passive suicidal ideation ((per EMR, patient's care team, study team, per item 9 of the PHQ-9, or the CSSRS).

Design outcomes

Primary

MeasureTime frameDescription
Acceptability (SSC-C participants)up to 3 monthsParticipants 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 monthsParticipants 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

MeasureTime frameDescription
Psychosocial distressup to 3 monthsThe Hospital Anxiety and Depression Scale (HADS) will assess symptoms of anxiety (7 items, range 0-21) and depression (7 items, range 0-21).

Countries

United States

Contacts

CONTACTDevika Jutagir, PhD
jutagird@mskcc.org646-888-8361
CONTACTFrancesca Gany, MD, MS
646-888-8054
PRINCIPAL_INVESTIGATORDevika Jutagir, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026