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Online Information and Support for Distance Caregivers

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ClinicalTrials.gov Identifier: NCT02666183
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Video-C Behavioral: Nurse Coaching Behavioral: Web-Only Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Study personnel administering questionnaire and follow-up questions with participants will be blinded to the arm assignment of the participant
Primary Purpose: Supportive Care
Official Title: Online Information and Support for Distance Caregivers
Actual Study Start Date : April 6, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Difference in change in anxiety over time between groups [ Time Frame: At 6 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 8-iten tool from the Patient Reported Outcomes measurement Information System (PROMIS). Higher scores indicate greater anxiety.

  2. Difference in change in distress over time between groups [ Time Frame: At 6 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.

  3. Difference in change in depression over time between groups [ Time Frame: At 6 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 8 item Patient Reported Outcomes Measurement Information System short form V1.0 ED-Depression-SF8a

  4. Difference in change in health status over time between groups [ Time Frame: At 6 months ]
    Compare the direct effects of Closer, Video-C Only, and Web-Only on health status over time, controlling for DCG demographic variables. Health status will be measured using a single item general self-rated health question (GSRH) from the Medical Outcomes Study-Short Form 12.


Secondary Outcome Measures :
  1. Difference in the change of caregiver burden between groups [ Time Frame: At 6 months ]
    Change in DCG outcomes indirectly through effects upon caregiver burden, when Closer arm is compared to Video-C and Web-Only. Care giver burden is conceptually defined as a caregiver's subjective belief that resources are insufficient to meet role demands; it will be operationally defined using Zarit's Burden interview-short form (SF) where higher scores indicate a greater sense of burden.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666183


Contacts
Contact: Sara Douglas, RN, PhD 216-368-0702 sld4@case.edu

Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sara Douglas, RN, PhD    216-368-0702    sld4@case.edu   
Principal Investigator: Sara Douglas, RN, PhD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Sara Douglas, RN, PhD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02666183     History of Changes
Other Study ID Numbers: CASE6Y15
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Case Comprehensive Cancer Center:
cancer
caregiver
videoconferencing