Online Information and Support for Distance Caregivers

Advanced Cancer Clinical Trial

Official title:

Online Information and Support for Distance Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666183
• Other study ID #: CASE6Y15
• Status: Completed
• Phase: N/A
• Start date: April 6, 2016
• Est. completion date: April 16, 2020

Study information

• Verified date: February 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: April 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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
• Nurse Coaching
structured conversations with registered nurses aimed at providing emotional support
• Web-Only
Access to a website with caregiving resources, resources for distant care givers, and cancer information

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Blackstone E, Lipson AR, Douglas SL. Closer: A videoconference intervention for distance caregivers of cancer patients. Res Nurs Health. 2019 Aug;42(4):256-263. doi: 10.1002/nur.21952. Epub 2019 May 22. — View Citation

Blackstone EC, Douglas SL, Lipson AR. Videoconferencing empowers distance caregivers to be more involved in care. Oncology Nursing News. 2019; Jan/Feb.

Douglas SL, Mazanec P, Lipson AR, Blackstone E, Day K, Bajor DL, Krishnamurthi SS. Video conference intervention for distance caregivers (DCGs) of patients with cancer: Improving psychological outcomes. Journal of Clinical Oncology. 2020; 38:15 (supplemen

Douglas SL, Mazanec P, Lipson AR, Day K, Blackstone E, Bajor DL, Saltzman J, Krishnamurthi S. Videoconference Intervention for Distance Caregivers of Patients With Cancer: A Randomized Controlled Trial. JCO Oncol Pract. 2021 Jan;17(1):e26-e35. doi: 10.120 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Anxiety T-scores	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)
Primary	Change in Distress Scores	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)
Primary	Change in Depression T-scores	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)