Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden

August 9, 2018 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: This web-based CCC Workshop
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.
Other: webcasts
Behavioral: Assessments
Active Comparator: Waitlist Control
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.
Other: Usual care
Behavioral: Assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of this novel approach
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

American Cancer Society, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-208

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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