Clinical trial NCT03686007: Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients
Official title: A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver
Stage I Lung Cancer AJCC v7
Stage IA Lung Cancer AJCC v7
Stage IB Lung Cancer AJCC v7
Stage II Lung Cancer AJCC v7
Stage IIA Lung Cancer AJCC v7
Stage IIB Lung Cancer AJCC v7
Stage III Lung Cancer AJCC v7
Stage IIIA Lung Cancer AJCC v7
Stage IIIB Lung Cancer AJCC v7
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-26
Enrollment: 380
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized phase III trial studies how well a multimedia self-management intervention works in preparing family caregivers and patients with stage I-III lung cancer for lung cancer surgery. The multimedia self-management intervention, Preparing for your Lung Cancer Surgery, is a nurse-led, caregiver-based, multimedia intervention that may improve patient recovery after surgery, lower caregiving burden, and improve distress and quality of life.

Detailed description: PRIMARY OBJECTIVES:

I. Test the effects of the multimedia self-management (MSM) intervention on family caregivers (FCG) outcomes and cancer support services use at discharge and 3-month post-discharge, comparing intervention and attention control groups.

II. Test the effects of the MSM intervention on patient outcomes and healthcare resource use at discharge and 3-months post-discharge, comparing intervention and attention control groups.

III. Test the effects of the MSM intervention on outcome mediators at discharge and 3-months post-discharge, comparing intervention and attention control groups.

SECONDARY OBJECTIVES:

I. Explore moderators (age, sex, marital status, caregiver relationship to patient, caregiver employment status, co-morbidities) of FCG and patient outcomes and reciprocal relationships.

II. Determine, through exit interviews, participant's experience with the MSM intervention.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients and FCGs receive the MSM intervention consisting of videos, a handbook, and research nurse coaching over 40-60 minutes, approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive research nurse support by telephone (separate sessions for FCGs and patients) over 20-30 minutes at 2 and 7 days, and 2 months post-discharge.

GROUP II: Patients and FCGs receive attention control intervention consisting of videos (American Cancer Society video on "Clinical Trials"), American Cancer Society print materials, and assistance from a clinical research associate (CRA) approximately 3-7 days before surgery and within 24 hours of planned discharge. Patients and FCGs also receive assistance from CRAs via telephone calls at 2 and 7 days, and 2 months post-discharge.

Eligibility criteria: Family Caregiver Inclusion Criteria:

* A family member or friend identified by the patient as being the primary care provider before and after surgery
* A patient/care recipient enrolled in the study
* Age 21 years or older
* Able to read or understand English

Patient Inclusion Criteria:

* Diagnosis of Stage I-III non-small cell lung cancer
* Scheduled to undergo surgery for treatment
* A family caregiver enrolled in the study
* Age 21 years or older
* Able to read or understand English.

Primary outcomes:
measure: Change in Family Caregiver Psychological Distress (as Measured by the Distress Thermometer)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Caregiving Burden (as Measured by the Montgomery Borgatta Caregiver Burden Scale)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Preparedness for Caregiving (as Measured by the Preparedness for Caregiving Scale)
timeFrame: Outcomes are measured before surgery (baseline), 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Family Caregiver Quality of Life (as Measured by the City of Hope-Quality of Life-Family (COH-QOL-Family)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Number of Participants Who Used Family Caregiver Resource (as Measured by the Family Caregiver Healthcare Use Inventory)
timeFrame: Outcomes are measured at discharge, 1 month, and 3 months post-discharge.
measure: Change in Patient Psychological Distress (as Measured by the Distress Thermometer)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Patient Quality of Life (as Measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Number of Participants Who Used Patient Healthcare Resource Use (Home Health Nursing Care, Urgent/ER Visits, Hospital Readmissions)
timeFrame: Outcomes are measured at 1 month, and 3 months post-discharge.
Secondary outcomes:
measure: Change in Family Caregiver Self-efficacy (as Measured by the Self-Efficacy Scale)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Patient Self-efficacy (as Measured by the Self-Efficacy Scale)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Family Caregiver Activation (as Measured by the FCG Activation in Transitions Tool)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Patient Activation (as Measured by the Patient Activation Measure)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge. Absolute values are reported at each timeframe.
measure: Change in Family Caregiver Knowledge (as Measured by the Surgery-Related Knowledge Tool)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge
measure: Change in Patient Knowledge (as Measured by the Surgery-Related Knowledge Tool)
timeFrame: Outcomes are measured at baseline, 1 month, and 3 months post-discharge
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Hope Medical Center
name: Jae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun V, Raz DJ, Erhunmwunsee L, Ruel N, Carranza J, Prieto R, Ferrell B, Krouse RS, McCorkle R, Kim JY. Improving family caregiver and patient outcomes in lung cancer surgery: Study protocol for a randomized trial of the multimedia self-management (MSM) intervention. Contemp Clin Trials. 2019 Aug;83:88-96. doi: 10.1016/j.cct.2019.07.002. Epub 2019 Jul 3.