ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    distance caregiver

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128373
Recruitment Status : Terminated (Slow Accrual)
First Posted : May 1, 2014
Last Update Posted : February 18, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Stage IV Lung Cancer Malignant Brain Tumor 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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Computer-Based Intervention for Distance Caregivers of Parents With Advanced Cancer
Study Start Date : November 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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: computer-assisted intervention
Caregiver will virtually attend visit using the CLOSER intervention

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




Primary Outcome Measures :
  1. Primary stressors (type and stage/grade of cancer, and patient QOL) [ Time Frame: Baseline ]
    Regression analysis will be run to explore the influence of primary stressors and structural factors on patient and caregiver outcomes (anxiety and distress).

  2. effect of CLOSER intervention on caregiver anxiety [ Time Frame: Up to 96 hours after week 5 visit ]
    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

  3. Frequency of technological errors [ Time Frame: Up to 96 hours after week 5 visit ]
    Will be used to determine the feasibility of using Adobe's computer-based web communication system.

  4. Length of time of physician office visit [ Time Frame: Up to 96 hours after week 5 visit ]
    Will be used to determine the feasibility of using Adobe's computer-based web communication system.

  5. Perceived ease of use [ Time Frame: Up to 96 hours after week 5 visit ]
    Will be used to determine the feasibility of using Adobe's computer-based web communication system.

  6. effect of CLOSER intervention on caregiver distress [ Time Frame: Up to 96 hours after week 5 visit ]
    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

  7. effect of CLOSER intervention on patient distress [ Time Frame: Up to 96 hours after week 5 visit ]
    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

  8. effect of CLOSER intervention on patient anxiety [ Time Frame: Up to 96 hours after week 5 visit ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128373


Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sara Douglas, RN, PhD Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02128373     History of Changes
Other Study ID Numbers: CASE3Z11
NCI-2014-00812 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE3Z11
CASE 3Z11 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases