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

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.

Study Overview

• Status: Terminated
• Conditions: Stage IV Lung Cancer; Malignant Brain Tumor
• Intervention / Treatment: Procedure: Usual care; Other: Distress Thermometer; Other: Profile of Mood States (POMS-B); Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT); Other: Tension-Anxiety Subscale; Other: computer-assisted intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Usual care; Health care provided by physician, physician's nurse, and social worker; Other: Distress Thermometer; Average score of a one item scale (range 0-10) where higher scores indicate more distress; Other: 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; Other: 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; Other: Tension-Anxiety Subscale; six item scale which asks to qualitatively describe which areas in you life are causing stress
Experimental: 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	Procedure: Usual care; Health care provided by physician, physician's nurse, and social worker; Other: Distress Thermometer; Average score of a one item scale (range 0-10) where higher scores indicate more distress; Other: 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; Other: 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; Other: Tension-Anxiety Subscale; six item scale which asks to qualitatively describe which areas in you life are causing stress; Other: computer-assisted intervention; Caregiver will virtually attend visit using the CLOSER intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sara Douglas, RN, PhD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: CASE3Z11; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00812 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 3Z11 (Other Identifier: Case Comprehensive Cancer Center)