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

Case Comprehensive Cancer Center (Case CCC)

Status: Terminated

Conditions: Malignant Brain Tumor; Stage IV Lung Cancer

Treatments: Procedure: Usual care; Other: computer-assisted intervention; Other: Tension-Anxiety Subscale; Other: Profile of Mood States (POMS-B); Other: Distress Thermometer; Other: Quality of Life: Functional Assessment in Cancer Therapy - (FACT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02128373

P30CA043703 (U.S. NIH Grant/Contract)

NCI-2014-00812 (Registry Identifier)

CASE3Z11

CASE 3Z11 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7 participants in 2 patient groups

Arm I (usual care)

Active Comparator group

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

Treatment:

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

Other: Profile of Mood States (POMS-B)

Procedure: Usual care

Other: Tension-Anxiety Subscale

Other: Distress Thermometer

Arm II (usual care with CLOSER intervention)

Experimental group

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

Treatment:

Other: computer-assisted intervention

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

Other: Profile of Mood States (POMS-B)

Procedure: Usual care

Other: Tension-Anxiety Subscale

Other: Distress Thermometer