Breast CancerNCT07218250
A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Cancer
A study testing Single Counseling Session and American Cancer Society booklet in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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 cancer who are waiting to receive ongoing counseling services (outpatient psychotherapy services). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single Counseling Session and American Cancer Society booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesUnited States
- Study dates
- 4 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have pathologically confirmed 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)
- Age ≥ 18 (per EMR)
- English fluency - Per self-report: How well do you speak English?
Show all 11Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Francesca Gany, MD, MS contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
Commack, New York, 11725
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Devika Jutagir, PhD, 646-888-8361
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Devika Jutagir, PhD, 646-888-8361
About this study
Official title: Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Cancer Patients
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 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.
- Conditions
- Breast Cancer
- Being tested
- Single Counseling Session, American Cancer Society booklet
- Keywords
- Counseling Session, Reduce Depression, Reduce Anxiety, Reduce Distress, 25-281
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Counseling SessionBehavioural
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
American Cancer Society bookletOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SSC-C - Single Session Consultation for Cancer | Experimental | will receive the study counseling Receives: Behavioral: Single Counseling Session |
| PPSB - Psychosocial Patient Support Booklet | Active comparator | will receive an American Cancer Society booklet for review (and no counseling) Receives: Other: American Cancer Society booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability (SSC-C participants)
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.
Measured: up to 3 months
Acceptability (PPSB participants)
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.
Measured: up to 3 months
Secondary outcomes (1)
Psychosocial distress
The Hospital Anxiety and Depression Scale (HADS) will assess symptoms of anxiety (7 items, range 0-21) and depression (7 items, range 0-21).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start4 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Sponsor
- Investigators
- Devika Jutagir, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218250
- Sponsor's protocol ID
- 25-281
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Single Session Consultation for Cancer (SSC-C) to Alleviate Distress Among Cancer Patients
- ClinicalTrials.gov ID
- NCT07218250
- Acronym / sponsor ID
- 25-281
- Conditions
- Breast Cancer
- Keywords
- Counseling Session, Reduce Depression, Reduce Anxiety, Reduce Distress, 25-281
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSC-C - Single Session Consultation for Cancer | Experimental | Behavioral: Single Counseling Sessionwill receive the study counseling |
| PPSB - Psychosocial Patient Support Booklet | Active comparator | Other: American Cancer Society bookletwill receive an American Cancer Society booklet for review (and no counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient must have pathologically confirmed 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)
- Age ≥ 18 (per EMR)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Counseling SessionThe 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 | Behavioural | SSC-C - Single Session Consultation for Cancer |
| American Cancer Society bookletcalled "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. | Other | PPSB - Psychosocial Patient Support Booklet |
Primary outcome
Acceptability (SSC-C participants)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Psychosocial distress
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Gany, MD, MS contact
Devika Jutagir, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Counseling Session and American Cancer Society booklet in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devika Jutagir, PhD (646-888-8361, jutagird@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (SSC-C participants) (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.