Clinical trial NCT02128373: A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
Official title: A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage IV Lung Cancer
Malignant Brain Tumor
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-01
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* Capable of providing informed consent
* Computer ownership with internet access

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)

Primary outcomes:
measure: Primary stressors (type and stage/grade of cancer, and patient QOL)
timeFrame: Baseline
measure: effect of CLOSER intervention on caregiver anxiety
timeFrame: Up to 96 hours after week 5 visit
measure: Frequency of technological errors
timeFrame: Up to 96 hours after week 5 visit
measure: Length of time of physician office visit
timeFrame: Up to 96 hours after week 5 visit
measure: Perceived ease of use
timeFrame: Up to 96 hours after week 5 visit
measure: effect of CLOSER intervention on caregiver distress
timeFrame: Up to 96 hours after week 5 visit
measure: effect of CLOSER intervention on patient distress
timeFrame: Up to 96 hours after week 5 visit
measure: effect of CLOSER intervention on patient anxiety
timeFrame: Up to 96 hours after week 5 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Sara Douglas, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: