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

Primary Purpose

Stage IV Lung Cancer, Malignant Brain Tumor

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
computer-assisted intervention
Distress Thermometer
Profile of Mood States (POMS-B)
Quality of Life: Functional Assessment in Cancer Therapy - (FACT)
Tension-Anxiety Subscale
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (usual care)

Arm II (usual care with CLOSER intervention)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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
Frequency of technological errors
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Length of time of physician office visit
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Perceived ease of use
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2014
Last Updated
February 16, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02128373
Brief Title
A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
Official Title
A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Lung Cancer, Malignant Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (usual care)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm II (usual care with CLOSER intervention)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Health care provided by physician, physician's nurse, and social worker
Intervention Type
Other
Intervention Name(s)
computer-assisted intervention
Intervention Description
Caregiver will virtually attend visit using the CLOSER intervention
Intervention Type
Other
Intervention Name(s)
Distress Thermometer
Intervention Description
Average score of a one item scale (range 0-10) where higher scores indicate more distress
Intervention Type
Other
Intervention Name(s)
Profile of Mood States (POMS-B)
Intervention Description
average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
Intervention Type
Other
Intervention Name(s)
Quality of Life: Functional Assessment in Cancer Therapy - (FACT)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Tension-Anxiety Subscale
Intervention Description
six item scale which asks to qualitatively describe which areas in you life are causing stress
Primary Outcome Measure Information:
Title
Primary stressors (type and stage/grade of cancer, and patient QOL)
Description
Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).
Time Frame
Baseline
Title
effect of CLOSER intervention on caregiver anxiety
Description
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
Time Frame
Up to 96 hours after week 5 visit
Title
Frequency of technological errors
Description
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Time Frame
Up to 96 hours after week 5 visit
Title
Length of time of physician office visit
Description
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Time Frame
Up to 96 hours after week 5 visit
Title
Perceived ease of use
Description
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Time Frame
Up to 96 hours after week 5 visit
Title
effect of CLOSER intervention on caregiver distress
Description
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
Time Frame
Up to 96 hours after week 5 visit
Title
effect of CLOSER intervention on patient distress
Description
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
Time Frame
Up to 96 hours after week 5 visit
Title
effect of CLOSER intervention on patient anxiety
Description
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
Time Frame
Up to 96 hours after week 5 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Douglas, RN, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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