An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
Primary Purpose
Metastatic Cancer, Locally Advanced Cancer, Thoracic Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly 45 minute Sessions
Sponsored by
About this trial
This is an interventional other trial for Metastatic Cancer focused on measuring Latina, Latino, Spanish, Caregiver, 18-530, Memorial Sloan Kettering Cancer Center
Eligibility Criteria
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."
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients
Caregivers
Arm Description
Latino/a advanced cancer patients
Caregivers of Latino/a advanced cancer patients
Outcomes
Primary Outcome Measures
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Feasibility of patient-caregiver communication-based intervention defined by participant retention
Secondary Outcome Measures
Full Information
NCT ID
NCT03794635
First Posted
December 21, 2018
Last Updated
August 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03794635
Brief Title
An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
Official Title
A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Locally Advanced Cancer, Thoracic Cancer, Gynecologic Cancer, Genitourinary Cancer, Lymphoma
Keywords
Latina, Latino, Spanish, Caregiver, 18-530, Memorial Sloan Kettering Cancer Center
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Latino/a advanced cancer patients
Arm Title
Caregivers
Arm Type
Experimental
Arm Description
Caregivers of Latino/a advanced cancer patients
Intervention Type
Behavioral
Intervention Name(s)
Weekly 45 minute Sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of patient-caregiver communication-based intervention defined by participant enrollment
Time Frame
3 months
Title
Feasibility of patient-caregiver communication-based intervention defined by participant retention
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Trevino, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
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An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer
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