Clinical trial NCT02666183: Online Information and Support for Distance Caregivers
Official title: Online Information and Support for Distance Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: cancer
caregiver
videoconferencing
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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?

Eligibility 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

Primary outcomes:
measure: Change in Anxiety T-scores
timeFrame: At enrollment to end of intervention period (4 months)
measure: Change in Distress Scores
timeFrame: At enrollment to end of intervention period (4 months)
measure: Change in Depression T-scores
timeFrame: At enrollment to end of intervention period (4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Sara Douglas, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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: 10.1200/OP.20.00576.
citation: Blackstone E, Douglas SL, Lipson AR. Videoconferencing Empowers Distance Caregivers to Be More Involved in Care. Oncol Nurs News. 2019 Jan-Feb;13(1):https://www.oncnursingnews.com/view/videoconferencing-empowers-distance-caregivers-to-be-more-involved-in-care. Epub 2019 Feb 8.
citation: 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 (supplement); 12123.