Multimedia Self-Management Intervention for Lung Cancer Surgery Family Caregivers and Patients
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 11/23/2018 |
Start Date: | November 6, 2018 |
End Date: | August 31, 2023 |
A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
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.
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.
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.
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.
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.
We found this trial at
1
site
Duarte, California 91010
Principal Investigator: Virginia Sun, RN, PhD
Phone: 626-218-3122
Click here to add this to my saved trials