Back to resultsCare For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
Primary Purpose
Caregivers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
webcasts
Assessments
Usual care
Sponsored by
About this trial
This is an interventional other trial for Caregivers focused on measuring Caregivers of patients, CCC = Care for the Cancer Caregivers, MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers, 14-208
Eligibility Criteria
Inclusion Criteria:
- As per self report, a current caregiver to a patient with any site or stage of cancer
- Age 18 or over
- A score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
- In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
- Able to perform informed consent
- Enrollment is open to caregivers with their own current/past cancer histories
Exclusion Criteria:
- Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
- As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
- Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
This web-based CCC Workshop
Waitlist Control
Arm Description
The Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role.
Participants randomized to the waitlist control arm will be offered what is considered "usual care" at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop.
Outcomes
Primary Outcome Measures
feasibility of this novel approach
which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) methods.
Secondary Outcome Measures
Full Information
NCT ID
NCT02250911
First Posted
September 24, 2014
Last Updated
August 9, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02250911
Brief Title
Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
Official Title
Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
American Cancer Society, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Based on the information we obtain, we hope to develop an easily accessible support service for caregivers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers
Keywords
Caregivers of patients, CCC = Care for the Cancer Caregivers, MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers, 14-208
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
This web-based CCC Workshop
Arm Type
Experimental
Arm Description
The Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
Participants randomized to the waitlist control arm will be offered what is considered "usual care" at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop.
Intervention Type
Other
Intervention Name(s)
webcasts
Intervention Type
Behavioral
Intervention Name(s)
Assessments
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
feasibility of this novel approach
Description
which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) methods.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
As per self report, a current caregiver to a patient with any site or stage of cancer
Age 18 or over
A score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
Able to perform informed consent
Enrollment is open to caregivers with their own current/past cancer histories
Exclusion Criteria:
Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Applebaum, 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
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
We'll reach out to this number within 24 hrs