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Completed

NCT Number: NCT02666183

Online Information and Support for Distance Caregivers

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.

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Key information

Conditions

Advanced Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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:

  • 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?
  • 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?
  • Are there significant relationships between DCG distress, anxiety, depression and health status and patient distress, anxiety and depression over time?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video-C

Behavioral

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

Nurse Coaching

Behavioral

structured conversations with registered nurses aimed at providing emotional support

Web-Only

Behavioral

Access to a website with caregiving resources, resources for distant care givers, and cancer information

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2016
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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