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Clinical Trials/NCT02128373
NCT02128373
Terminated
Not Applicable

A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer

Case Comprehensive Cancer Center1 site in 1 country7 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stage IV Lung Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
7
Locations
1
Primary Endpoint
effect of CLOSER intervention on caregiver anxiety
Status
Terminated
Last Updated
11 years ago

Overview

Brief Summary

This pilot clinical trial studies the feasibility and effectiveness of a new computer-based communication intervention in supporting distance caregivers of patients with advanced lung or brain cancer. Unlike local caregivers, distance caregivers often receive little, if any, professional support and have limited communication with the oncology team. Using a computer-based communication intervention to allow distance caregivers the opportunity to participate in a physician visit, have questions and concerns addressed, and meet members of the oncology team may help reduce stress.

Detailed Description

PRIMARY OBJECTIVES: I. What is the relationship of primary stressors (type and stage/grade of cancer, and patient quality of life \[QOL\]) and structural factors/stressors (age, gender, race, and education) with patient and caregiver psychological outcomes at baseline? II. What are the effects of the Communication with Long Distance Caregivers Offering a Supportive Electronic Resource (CLOSER) intervention on distance caregiver psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? III. What are the effects of the CLOSER intervention on patient psychological outcomes (anxiety and distress), controlling for primary stressors (type and stage/grade of cancer, and patient quality of life), distance caregiver structural factors/stressors (caregiver age, gender, race, and employment), and baseline anxiety and distress? IV. What is the feasibility (time, cost, resources and acceptability to patients, caregivers and clinicians) of using Adobe Connect, a computer-based web communication system, with the distance caregiver, the parent with advanced cancer, and the health care providers together in a routine follow-up oncology office visit? V. What is the experience of being a distance caregiver participating in the CLOSER intervention? OUTLINE: Participants are assigned to 1 of 2 arms. ARM I: Participants receive usual care for 5 weeks. During the week 5 office visit, distance caregivers are not present. ARM II: Participants receive usual care for 5 weeks. During the week 5 visit, distance caregivers virtually attend using the CLOSER intervention with computer video and audio connection. After completion of study, participants are followed up within 48-96 hours.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • INCLUSION CRITERIA FOR PATIENTS:
  • Having a diagnosis of advanced lung cancer or malignant brain tumor for two to six months
  • Receiving on-going care from the medical oncologist at the Seidman Cancer Center
  • Having a primary and distance caregiver involved in their care, support, and/or care planning
  • English as a primary language
  • Capacity to provide informed consent, as validated by the oncologist
  • INCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
  • Family caregiver of a patient with advanced lung cancer or malignant brain tumor
  • Patient and distance caregiver perception that this caregiver's geographic location is such that precludes routine participation in medical appointments
  • English as primary language

Exclusion Criteria

  • EXCLUSION CRITERIA FOR PATIENTS:
  • No primary caregiver
  • Enrolled in hospice
  • EXCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
  • Those who routinely participate in most of the patient's medical appointments (once or more per month)

Outcomes

Primary Outcomes

effect of CLOSER intervention on caregiver anxiety

Time Frame: Up to 96 hours after week 5 visit

A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention caregiver groups

Frequency of technological errors

Time Frame: Up to 96 hours after week 5 visit

Will be used to determine the feasibility of using Adobe's computer-based web communication system.

Length of time of physician office visit

Time Frame: Up to 96 hours after week 5 visit

Will be used to determine the feasibility of using Adobe's computer-based web communication system.

effect of CLOSER intervention on patient distress

Time Frame: Up to 96 hours after week 5 visit

A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention patient groups

Primary stressors (type and stage/grade of cancer, and patient QOL)

Time Frame: Baseline

Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).

effect of CLOSER intervention on patient anxiety

Time Frame: Up to 96 hours after week 5 visit

A two sample t-test will be conducted to compare differences in baseline to post-treatment POMS-B scores between the usual care and intervention patient groups

Perceived ease of use

Time Frame: Up to 96 hours after week 5 visit

Will be used to determine the feasibility of using Adobe's computer-based web communication system.

effect of CLOSER intervention on caregiver distress

Time Frame: Up to 96 hours after week 5 visit

A two sample t-test will be conducted to compare differences in baseline to post-treatment Distress Thermometer scores between the usual care and intervention caregiver groups

Study Sites (1)

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