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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02128373
Other study ID # CASE3Z11
Secondary ID NCI-2014-00812CA
Status Terminated
Phase N/A
First received April 29, 2014
Last updated February 16, 2015
Start date November 2011
Est. completion date December 2014

Study information

Verified date February 2015
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Procedure:
Usual care
Health care provided by physician, physician's nurse, and social worker
Other:
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

Locations

Country Name City State
United States Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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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