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An Intervention to Help Patients and Caregivers Manage Stress and Improve Communication Skills When Talking About Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794635
Recruitment Status : Active, not recruiting
First Posted : January 7, 2019
Last Update Posted : August 22, 2022
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Locally Advanced Cancer Thoracic Cancer Gynecologic Cancer Genitourinary Cancer Lymphoma Behavioral: Weekly 45 minute Sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Communication-Based Intervention for Cancer Patient-Caregiver Dyads to Increase Engagement Treatment Planning and Reduce Caregiver Burden
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Patients
Latino/a advanced cancer patients
Behavioral: Weekly 45 minute Sessions

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:

  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.


Experimental: Caregivers
Caregivers of Latino/a advanced cancer patients
Behavioral: Weekly 45 minute Sessions

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:

  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.





Primary Outcome Measures :
  1. Feasibility of patient-caregiver communication-based intervention defined by participant enrollment [ Time Frame: 3 months ]
  2. Feasibility of patient-caregiver communication-based intervention defined by participant retention [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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."

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794635


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Kelly Trevino, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03794635    
Other Study ID Numbers: 18-530
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Latina
Latino
Spanish
Caregiver
18-530
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Urogenital Neoplasms
Neoplasms
Neoplasms by Site