An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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"
Exclusion Criteria:
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:
- 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."
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Patients
Latino/a advanced cancer patients
|
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:
Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention. |
|
Experimental: Caregivers
Caregivers of Latino/a advanced cancer patients
|
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:
Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Time Frame: 3 months
|
3 months
|
|
Feasibility of patient-caregiver communication-based intervention defined by participant retention
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Kelly Trevino, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplastic Processes
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Lymphoma
- Neoplasm Metastasis
- Urogenital Neoplasms
Other Study ID Numbers
Other Study ID Numbers
- 18-530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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