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

Stage IV Lung Cancer Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Tumor
• Stage IV Lung Cancer

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