Metastatic CancerNCT03794635
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
A study testing Weekly 45 minute Sessions in people with Metastatic Cancer and Locally Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Cancer, Locally Advanced Cancer, Thoracic Cancer
- What is being tested?
- Weekly 45 minute Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Patients:
- Self-identifies as Latino/a
- Diagnosis of poor prognosis advanced cancer defined as: (1) locally advanced or metastatic cancer (i.e., thoracic, gynecological, genitourinary cancer, pancreatic or lymphoma) or (2) disease progression following at least first line treatment
- Fluent in English or Spanish
- Age 18 or older
- Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study
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- Score of </= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- To assess whether a prognostic discussion occurred, the oncologist must answer "Yes" to the following: "Have you discussed the any of the following with Mr./Mrs./Ms. [INSERT PATIENT"S NAME]: If his/her cancer is curable, if his/her cancer is terminal, or his/her life expectancy: Yes/No Note: This question will be included in the email in which study staff request permission to contact the patient.
- As per self-report, residency in New York or ability to complete sessions in New York to ensure that provision of TAC is covered by the professional licenses of TAC interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3 ONLY
- Able to communicate over the phone for sessions
- Willingness to be audio-recorded for assessments and study sessions
- For Caregivers:
- Is a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for a MSK patient
- Fluent in English or Spanish
- Age 18 or older
- Score of </= 10 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- As per self-report, residency in New York or ability to complete sessions in New York to ensure that provision of TAC is covered by the professional licenses of TAC interventionists (i.e., social workers licensed in New York State) - AIMS 2 and 3 ONLY
- Able to communicate over the phone for sessions
- Willingness to be audio-recorded for assessments and study sessions
- Psychosocial expert eligibility requirements:
- Current clinical practice and/or research with advanced cancer patients
- A history of 5+ years working with advanced cancer patients. Experts across disciplines (e.g., social work, psychology) may be enrolled.
- Fluent in English as self-reported by a fluency of "Very well"
Who cannot join
- For Patients
- As judged by the consenting professional, treating physician or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
- Receiving hospice at the time of enrollment
- Deemed inappropriate for the study by their treating physician
- As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- For Caregivers:
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- As judged by the consenting professional, treating physician or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
- As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
- Patient-Caregiver Dyads:
- Both dyad members respond "b" or "d" on the item in Appendix K, "How would you describe your/the patient"s health status: a) Relatively healthy, b) Relatively healthy and terminally ill, c) Seriously ill but not terminally ill, or d) Seriously and terminally ill" and respond "months" on the item "When you think about your/the patient's life expectancy, do you think in terms of months or years."
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden
This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this study, and a version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. We will use the culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants. This culturally sensitive intervention has the potential to reduce Latino/a patient and caregiver distress and improve patient and caregiver quality of life, shared understanding of the patient's illness, and patients' and caregivers' ability to discuss, identify, and document patients' treatment preferences. The intervention is designed to minimize burden to patients, caregivers, and healthcare institutions to allow for easy integration into clinical practice.
- Conditions
- Metastatic Cancer, Locally Advanced Cancer, Thoracic Cancer, Gynecologic Cancer, Genitourinary Cancer, Lymphoma
- Being tested
- Weekly 45 minute Sessions
- Keywords
- Latina, Latino, Spanish, Caregiver, 18-530, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Neoplasm Metastasis, Urogenital Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly 45 minute SessionsBehavioural
The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study:
- A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish)
- A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window.
Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Latino/a advanced cancer patients Receives: Behavioral: Weekly 45 minute Sessions |
| Caregivers | Experimental | Caregivers of Latino/a advanced cancer patients Receives: Behavioral: Weekly 45 minute Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Measured: 3 months
Feasibility of patient-caregiver communication-based intervention defined by participant retention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start20 Dec 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Kelly Trevino, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794635
- Sponsor's protocol ID
- 18-530
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden
- ClinicalTrials.gov ID
- NCT03794635
- Acronym / sponsor ID
- 18-530
- Conditions
- Metastatic Cancer, Locally Advanced Cancer, Thoracic Cancer, Gynecologic Cancer, Genitourinary Cancer, Lymphoma
- Keywords
- Latina, Latino, Spanish, Caregiver, 18-530, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2019 (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.
This study will test an intervention to improve patients' and their caregivers' ability to manage difficult emotions and communicate about the patient's illness. There will be two versions of the intervention used for this study: a culturally tailored version for Latinx participants refined during Phase 1 of this study, and a version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. We will use the culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants. This culturally sensitive intervention has the potential to reduce Latino/a patient and caregiver distress and improve patient and caregiver quality of life, shared understanding of the patient's illness, and patients' and caregivers' ability to discuss, identify, and document patients' treatment preferences. The intervention is designed to minimize burden to patients, caregivers, and healthcare institutions to allow for easy integration into clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Behavioral: Weekly 45 minute SessionsLatino/a advanced cancer patients |
| Caregivers | Experimental | Behavioral: Weekly 45 minute SessionsCaregivers of Latino/a advanced cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Self-identifies as Latino/a
- Diagnosis of poor prognosis advanced cancer defined as: (1) locally advanced or metastatic cancer (i.e., thoracic, gynecological, genitourinary cancer, pancreatic or lymphoma) or (2) disease progression following at least first line treatment
- Fluent in English or Spanish
- Age 18 or older
- Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study
Key exclusion criteria (10 listed)
- For Patients
- As judged by the consenting professional, treating physician or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments
- Receiving hospice at the time of enrollment
- Deemed inappropriate for the study by their treating physician
- As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
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 |
|---|---|---|
| Weekly 45 minute SessionsThe current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study: 1. A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish) 2. A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window. Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention. | Behavioural | Caregivers, Patients |
Primary outcome
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Time frame: 3 months
Feasibility of patient-caregiver communication-based intervention defined by participant retention
Time frame: 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 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Kelly Trevino, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly 45 minute Sessions in people with Metastatic Cancer and Locally Advanced Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 23 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment (time frame: 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 7 Jan 2026.