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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02128373

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

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	N/A

Detailed Description

PRIMARY OBJECTIVES:

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 Design

Study Type:

Interventional

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 :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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)

Other: Tension-Anxiety Subscale

six item scale which asks to qualitatively describe which areas in you life are causing stress

Outcome Measures

Primary Outcome Measures

Primary stressors (type and stage/grade of cancer, and patient QOL) [Baseline]
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 [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
Frequency of technological errors [Up to 96 hours after week 5 visit]
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Length of time of physician office visit [Up to 96 hours after week 5 visit]
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
Perceived ease of use [Up to 96 hours after week 5 visit]
Will be used to determine the feasibility of using Adobe's computer-based web communication system.
effect of CLOSER intervention on caregiver distress [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
effect of CLOSER intervention on patient distress [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
effect of CLOSER intervention on patient anxiety [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT02128373

Other Study ID Numbers:

CASE3Z11
NCI-2014-00812
CASE3Z11
CASE 3Z11
P30CA043703

First Posted:

May 1, 2014

Last Update Posted:

Feb 18, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Brain Neoplasms

Study Results

No Results Posted as of Feb 18, 2015