A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
NCT ID: NCT02128373
Last Updated: 2015-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2011-11-30
2014-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (usual care)
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
Usual care
Health care provided by physician, physician's nurse, and social worker
Distress Thermometer
Average score of a one item scale (range 0-10) where higher scores indicate more distress
Profile of Mood States (POMS-B)
average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
Quality 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
Tension-Anxiety Subscale
six item scale which asks to qualitatively describe which areas in you life are causing stress
Arm II (usual care with CLOSER intervention)
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
Usual care
Health care provided by physician, physician's nurse, and social worker
computer-assisted intervention
Caregiver will virtually attend visit using the CLOSER intervention
Distress Thermometer
Average score of a one item scale (range 0-10) where higher scores indicate more distress
Profile of Mood States (POMS-B)
average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
Quality 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
Tension-Anxiety Subscale
six item scale which asks to qualitatively describe which areas in you life are causing stress
Interventions
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Usual care
Health care provided by physician, physician's nurse, and social worker
computer-assisted intervention
Caregiver will virtually attend visit using the CLOSER intervention
Distress Thermometer
Average score of a one item scale (range 0-10) where higher scores indicate more distress
Profile of Mood States (POMS-B)
average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
Quality 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
Tension-Anxiety Subscale
six item scale which asks to qualitatively describe which areas in you life are causing stress
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Enrolled in hospice
* Those who routinely participate in most of the patient's medical appointments (once or more per month)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sara Douglas, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2014-00812
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE3Z11
Identifier Type: -
Identifier Source: secondary_id
CASE 3Z11
Identifier Type: OTHER
Identifier Source: secondary_id
CASE3Z11
Identifier Type: -
Identifier Source: org_study_id
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