NCT02250911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

September 24, 2014

Last Update Submit

August 9, 2018

Conditions

Caregivers

Keywords

Caregivers of patientsCCC = Care for the Cancer CaregiversMCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers14-208

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

This web-based CCC Workshop

EXPERIMENTAL

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: webcastsBehavioral: Assessments

Waitlist Control

ACTIVE COMPARATOR

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.

Behavioral: AssessmentsOther: Usual care

Interventions

webcastsOTHER
This web-based CCC Workshop
AssessmentsBEHAVIORAL
This web-based CCC WorkshopWaitlist Control
Usual careOTHER
Waitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Study Officials

  • Allison Applebaum, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

September 26, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)