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

NCT02128373 | Terminated

• 4 other identifiers: CASE3Z11NCI-2014-00812CASE 3Z11P30CA043703
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Lung Cancer; Malignant Brain Tumor

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

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; Other: Distress Thermometer; Other: Profile of Mood States (POMS-B); Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT); Other: Tension-Anxiety Subscale

Arm II (usual care with CLOSER intervention)

EXPERIMENTAL

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; 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

Interventions

Usual care PROCEDURE

Health care provided by physician, physician's nurse, and social worker

Arm I (usual care); Arm II (usual care with CLOSER intervention)

computer-assisted intervention OTHER

Caregiver will virtually attend visit using the CLOSER intervention

Arm II (usual care with CLOSER intervention)

Distress Thermometer OTHER

Average score of a one item scale (range 0-10) where higher scores indicate more distress

Arm I (usual care); Arm II (usual care with CLOSER intervention)

Profile of Mood States (POMS-B) OTHER

average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort

Arm I (usual care); Arm II (usual care with CLOSER intervention)

Quality of Life: Functional Assessment in Cancer Therapy - (FACT) OTHER

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

Arm I (usual care); Arm II (usual care with CLOSER intervention)

Tension-Anxiety Subscale OTHER

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

Arm I (usual care); Arm II (usual care with CLOSER intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• No primary caregiver
• Enrolled in hospice
• Those who routinely participate in most of the patient's medical appointments (once or more per month)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sara Douglas, RN, PhD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

US (1)