Clinical Trials Directory

Trials / Terminated

TerminatedNCT02128373

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUsual careHealth care provided by physician, physician's nurse, and social worker
OTHERcomputer-assisted interventionCaregiver will virtually attend visit using the CLOSER intervention
OTHERDistress ThermometerAverage score of a one item scale (range 0-10) where higher scores indicate more distress
OTHERProfile of Mood States (POMS-B)average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
OTHERQuality of Life: Functional Assessment in Cancer Therapy - (FACT)Average score of FACT which quantitatively assesses brain cancer patient's physiological functional and quality of life. FACT questions are scored 0-4 with higher numbers indicating more functionality
OTHERTension-Anxiety Subscalesix item scale which asks to qualitatively describe which areas in you life are causing stress

Timeline

Start date
2011-11-01
Primary completion
2014-11-01
Completion
2014-12-01
First posted
2014-05-01
Last updated
2015-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02128373. Inclusion in this directory is not an endorsement.