Stage IV Lung Cancer, Malignant Brain Tumor
Conditions
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.
Interventions
PROCEDUREUsual care
Health care provided by physician, physician's nurse, and social worker
Caregiver will virtually attend visit using the CLOSER intervention
OTHERDistress Thermometer
Average 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 Subscale
six item scale which asks to qualitatively describe which areas in you life are causing stress
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary stressors (type and stage/grade of cancer, and patient QOL) | 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 caregiver anxiety | 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 | 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 | Up to 96 hours after week 5 visit | Will be used to determine the feasibility of using Adobe's computer-based web communication system. |
| Perceived ease of use | 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 | 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 |
| effect of CLOSER intervention on patient distress | 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 |
| effect of CLOSER intervention on patient anxiety | 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 |
Countries
United States
Outcome results
None listed