Trial Title:
A Study of Meaning-Centered Psychotherapy for Caregivers to People With Cancer
NCT ID:
NCT06307535
Condition:
Caregiver Burden
Caregiver Burnout
Caregiver Stress Syndrome
Conditions: Official terms:
Burnout, Psychological
Caregiver Burden
Conditions: Keywords:
Caregiver
Caregiver Stress Syndrome
Caregiver Burden
Caregiver Burnout
Memorial Sloan Kettering Cancer Center
23-376
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Meaning-Centered Psychotherapy for Caregivers
Description:
MCP-C is a stakeholder-informed, innovative, manualized intervention designed to assist
caregivers to connect to a sense of meaning and purpose in life, despite the challenges
of caregiving.
Arm group label:
Meaning-Centered Psychotherapy for Caregivers
Other name:
MCP-C
Intervention type:
Behavioral
Intervention name:
Supportive Psychotherapy for Caregivers
Description:
Standard of care supportive psychotherapy
Arm group label:
Supportive Psychotherapy for Caregivers
Other name:
SP-C
Summary:
Participants will complete 1 set of questionnaires about 2 weeks before beginning their
Meaning-Centered Psychotherapy for Caregivers/MCP-C or standard Supportive Psychotherapy
for Caregivers/SP-C sessions. These questionnaires will ask about participants' sense of
meaning and purpose in life, spiritual well-being, depression and/or anxiety, and social
support. Participants will then be assigned to receive either MCP-C or SP-C for 7
sessions. Participants will complete additional sets of questionnaires about 2 weeks, 6
months, and 12 months after their last session of MCP-C or SP-C. It will take between 35
and 50 minutes to complete each set of questionnaires.
After participants complete the MCP-C or SP-C sessions and all 4 sets of questionnaires,
their participation in this study will end. If participants decide not to complete all 7
sessions, they may still choose to complete the questionnaires.
Participants may remain in the study and continue to receive all 7 sessions of MCP-C or
SP-C even if their loved one passes away.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 or over;
- As per self-report, a current caregiver to a patient with Stage III or IV solid
tumor cancer currently receiving medical care of any kind (e.g., curative,
palliative);
- Experiences distress as evidenced by a score of 4 or greater on the Distress
Thermometer (DT) and an indication that this distress is associated with caregiving;
- As per self-report, can read and understand English;
- As per self-report, residing in New York, New Jersey, or Florida, or have the
ability to complete sessions while complying with current telehealth regulations.
Exclusion Criteria:
- Participant does not have a reasonable understanding of the study activities by the
judgment of the consenting professional;
- Engagement in regular individual psychotherapeutic support that the participant is
unable or unwilling to put on hold for the course of treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Miami (Data Collection AND Data Analysis)
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Wendy Lichtenthal, PhD
Phone:
305-243-8983
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent only)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talia Zaider, PhD
Phone:
646-888-0162
Email:
zaidert@mskcc.org
Start date:
February 29, 2024
Completion date:
March 1, 2029
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307535
http://www.mskcc.org