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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00812 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE3Z11 | |||
| CASE 3Z11 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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Slow Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers are not present. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer |
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| Arm II (usual care with CLOSER intervention) | Experimental | Participants receive usual care (care from physician, physician nurse, and social worker) for 5 weeks. During the week 5 office visit, distance caregivers will use a computer-assisted intervention to be present electronically with video and audio feed to provide psychosocial support. In the pre-physician interview patients will verbally complete the FACT, POMS-B, Tension-Anxiety subscale, Distress Thermometer. Distance caregivers will verbally complete the POMS-B, Tension-Anxiety subscale, and Distress Thermometer. Up to 96 hours after the week 5 visit, patients and caregivers will be interviewed about their experience during the intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Procedure | Health care provided by physician, physician's nurse, and social worker |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| effect of CLOSER intervention on patient distress |
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Inclusion Criteria:
INCLUSION CRITERIA FOR PATIENTS:
INCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
Exclusion Criteria:
EXCLUSION CRITERIA FOR PATIENTS:
EXCLUSION CRITERIA FOR DISTANCE CAREGIVERS:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Douglas, RN, PhD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| computer-assisted intervention | Other | Caregiver will virtually attend visit using the CLOSER intervention |
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| Distress Thermometer | Other | Average score of a one item scale (range 0-10) where higher scores indicate more distress |
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| Profile of Mood States (POMS-B) | Other | average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort |
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| Quality of Life: Functional Assessment in Cancer Therapy - (FACT) | Other | 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 |
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| Tension-Anxiety Subscale | Other | six item scale which asks to qualitatively describe which areas in you life are causing stress |
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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 |
| 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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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