A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer

Conditions
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Stage IV Lung Cancer, Malignant Brain Tumor

Intervention / Treatment
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* Procedure: Usual care
* Other: computer-assisted intervention
* Other: Distress Thermometer
* Other: Profile of Mood States (POMS-B)
* Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT)
* Other: Tension-Anxiety Subscale


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>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 | Procedure: Usual care<br>* Health care provided by physician, physician's nurse, and social worker<br>Other: Distress Thermometer<br>* Average score of a one item scale (range 0-10) where higher scores indicate more distress<br>Other: Profile of Mood States (POMS-B)<br>* average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort<br>Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT)<br>* 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<br>Other: Tension-Anxiety Subscale<br>* six item scale which asks to qualitatively describe which areas in you life are causing stress<br>|
| Experimental: Arm II (usual care with CLOSER intervention)<br>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 | Procedure: Usual care<br>* Health care provided by physician, physician's nurse, and social worker<br>Other: computer-assisted intervention<br>* Caregiver will virtually attend visit using the CLOSER intervention<br>Other: Distress Thermometer<br>* Average score of a one item scale (range 0-10) where higher scores indicate more distress<br>Other: Profile of Mood States (POMS-B)<br>* average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort<br>Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT)<br>* 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<br>Other: Tension-Anxiety Subscale<br>* six item scale which asks to qualitatively describe which areas in you life are causing stress<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |