Online Information and Support for Distance Caregivers

February 1, 2022 updated by: Case Comprehensive Cancer Center
This study seeks to test the effectiveness of two arms of an intervention that use videoconference technology for distance caregivers of patients with advanced cancer. The study is significant because the intervention will promote involvement of caregivers of patients with cancer and makes a compelling case for significance based on changing demographics and lifestyles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary goal of this randomized clinical trial is to compare outcomes (anxiety, distress, depression, health status) for distant care givers (DCGs) of patients with advanced cancer who are randomly assigned to either the full intervention arm (Closer), the video-only intervention arm (Video-C Only) or the control group (Web-Only). the goal is to determine which is most efficacious in improving outcomes over time for these caregivers. In addition, this study will examine the indirect effects of each arm of the intervention on DCG outcomes over time as well as explore the nature of relationships between patient and DCG distress, anxiety and depression over time.

The specific research questions include:

  1. Is there a difference in DCG outcomes (anxiety, distress, depression, health status) over time between caregivers in the Closer, Video-C Only, and Web-Only groups, controlling for DCG demographic variables?
  2. Are there significant indirect effects of Closer, Video-C Only, and Web-Only on DCG outcomes (anxiety, distress, depression, health status) over time, controlling for DCG demographic variables?
  3. Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Study Type

Interventional

Enrollment (Actual)

397

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive 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

Yes

Genders Eligible for Study

All

Description

Patient Inclusion Criteria:

  • a new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage
  • receives ongoing care from a medical oncologist at the Seidman Cancer Center
  • Has English as the primary language
  • Has a life expectancy of >6 months
  • Provides consent for his/her own treatment and procedures
  • Identifies a distant care giver (DCG) involved in his/her care, support or planning

Patient Exclusion Criteria:

  • The patient sample is limited to patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist because the full intervention is tailored to meet the needs of DCGs of patients with advanced cancer and/or patients receiving ongoing care from a medical oncologist

Caregiver Inclusion Criteria

  • Is an adult family member (at least 18 years old) of a patient with an advanced-stage cancer
  • Identifies himself/herself as a DCG for the patient
  • Lives >1 hour travel time away from the patient
  • Has English as his/her primary language
  • Is capable of providing informed consent
  • Will be able to access the internet (phone, computer, etc.)

Caregiver Exclusion Criteria

  • Cognitive Impairment

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Closer
The full intervention (Closer) is a tested intervention that uses videoconferencing technology (WebEx) for delivery and delivers the highest dose of the intervention. This arm of the intervention will deliver personalized information to the DCG (aimed at enhancing self-efficacy) and emotional support via nurse coaching as well as the opportunity for the DCG to talk with the oncologist and patient in "real time" during a minimum of four patient-oncologist office visits over a 4-month period (at least once/month). For patients who have more than one oncologist-patient meeting/month, the study will use the videoconference technology to allow the DCG to join as many of the join in as many of the oncologist-patient office visits as desired.
Behavioral: Video-C
use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Other Names:
  • Video Conferencing
Behavioral: Nurse Coaching
structured conversations with registered nurses aimed at providing emotional support
Active Comparator: Video-C Only
This arm will involve the delivery of information solely via the use of videoconference technology during the patient-oncologist-DCG visit. There is always the possibility that the DCG will receive emotional support from the oncologist during the office visit (as would potentially occur during a face-to-face meeting) - but this will not be "delivered" systematically as in the Closer intervention. As with the Closer intervention, the DCG will be able to participate in the patient-oncologist visit in "real time" during a minimum of four office visits over the 4-month study period (total dose ~5 hours). The procedure for these meetings will be the same as outlined for Closer but will not involve having the nurse involved in the videoconference sessions with the oncologist, patient, and DCG.
Behavioral: Video-C
use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
Other Names:
  • Video Conferencing
Active Comparator: Web-Only
This group will be provided access to a website that will provide the following major links: a) Caregiving Resources (links to National Family Caregiver Association," etc.), b)Resources for DCGs (links to the Caregiving from a Distance," etc.), c) Cancer Information (links to National Cancer Institute, etc.). DCGs will be told that the study team will track usage of the website in order to assess which areas of the website are used most frequently. Any questions or concerns regarding use of the website can be sent online to the study's technical site, and the support staff will respond within 24 hours. As is current practice, DCGs can call an oncology nurse or oncologist to ask specific questions. Web-Only will deliver the lowest dose of the intervention.
Behavioral: Web-Only
Access to a website with caregiving resources, resources for distant care givers, and cancer information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety T-scores
Time Frame: At enrollment to end of intervention period (4 months)

Compare the direct effects of Closer, Video-C Only, and Web-Only on anxiety over time, controlling for DCG demographic variables. Anxiety will be measured using the 4-item tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety.

The PROMIS Item Bank v1.0-Emotional Distress-Anxiety - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 37.1 to 83.1 with higher t-scores representing more anxiety.

The mean and standard deviation are as follows: M=50 (SD=10).

T-scores from 55-60 represent mild anxiety, 61-70 moderate anxiety and > 70 represent severe anxiety.
At enrollment to end of intervention period (4 months)
Change in Distress Scores
Time Frame: At enrollment to end of intervention period (4 months)

Compare the direct effects of Closer, Video-C Only, and Web-Only on distress over time, controlling for DCG demographic variables. Distress is conceptually defined as a negative state in which coping and adaptation processes fail to return the individual to physiological and/or psychological homeostasis. It will be measured using the National Comprehensive Cancer Network (NCCN) distress thermometer - a clinical tool currently utilized with the cancer population.

The National Comprehensive Cancer Network Distress Thermometer is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.

Scores range from 0 to 10 with higher scores representing higher levels of distress.

Scores >4 indicate distress requiring further evaluation.
At enrollment to end of intervention period (4 months)
Change in Depression T-scores
Time Frame: At enrollment to end of intervention period (4 months)

Compare the direct effects of Closer, Video-C Only, and Web-Only on depression over time, controlling for DCG demographic variables. Depression will be measured using the 4 item PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a.

The PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, a 4 item instrument, is reported as a t-score and can range from 38.2 to 81.3 with higher t-scores representing worse depression.

T-scores from 55-60 represent mild depression, 61-70 moderate depression and > 70 represent severe depression.
At enrollment to end of intervention period (4 months)

Collaborators and Investigators

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

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Sara Douglas, RN, PhD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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.

General Publications

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 (Actual)

April 6, 2016

Primary Completion (Actual)

April 16, 2020

Study Completion (Actual)

April 16, 2020

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CASE6Y15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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