Stage IV Lung Cancer Clinical Trial
Official title:
A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | December 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary stressors (type and stage/grade of cancer, and patient QOL) | Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress). | Baseline | No |
Primary | effect of CLOSER intervention on caregiver anxiety | 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 | Up to 96 hours after week 5 visit | No |
Primary | Frequency of technological errors | Will be used to determine the feasibility of using Adobe's computer-based web communication system. | Up to 96 hours after week 5 visit | No |
Primary | Length of time of physician office visit | Will be used to determine the feasibility of using Adobe's computer-based web communication system. | Up to 96 hours after week 5 visit | No |
Primary | Perceived ease of use | Will be used to determine the feasibility of using Adobe's computer-based web communication system. | Up to 96 hours after week 5 visit | No |
Primary | effect of CLOSER intervention on caregiver distress | 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 | Up to 96 hours after week 5 visit | No |
Primary | effect of CLOSER intervention on patient distress | 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 | Up to 96 hours after week 5 visit | No |
Primary | effect of CLOSER intervention on patient anxiety | 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 | Up to 96 hours after week 5 visit | No |
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