Caregiver Clinical Trial
Official title:
A Multimedia Self-management Intervention to Prepare Family Caregivers and Patients for Lung Cancer Surgery
Verified date | February 2024 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 355 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in family caregiver psychological distress (as measured by the Distress Thermometer) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in caregiving burden (as measured by the Montgomery Borgatta Caregiver Burden Scale) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in preparedness for caregiving (as measured by the Preparedness for Caregiving Scale) | outcomes are measured before surgery (baseline), 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in family caregiver quality of life (as measured by the City of Hope-Quality of Life-Family (COH-QOL-Family) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in family caregiver resource use (as measured by the Family Caregiver Healthcare Use Inventory) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in patient psychological distress (as measured by the Distress Thermometer) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in patient quality of life (as measured by the Functional Assessment of Cancer Therapy-Lung - FACT-L) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Primary | Change in patient healthcare resource use (home health nursing care, urgent/ER visits, hospital readmissions) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Secondary | Change in family caregiver and patient self-efficacy (as measured by the Self-Efficacy Scale) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Secondary | Change in family caregiver activation (as measured by the FCG Activation in Transitions Tool) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Secondary | Change in patient activation (as measured by the Patient Activation Measure) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge | ||
Secondary | Change in family caregiver and patient knowledge (as measured by the Surgery-Related Knowledge Tool) | outcomes are measured at baseline, 1 day before discharge, 1 month, and 3 months post-discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03671226 -
Preference of Room Setting and Waiting Time in Patients With Advanced, Locally Advanced, or Metastatic Cancer and Their Caregivers Who Are Seen in the Outpatient Supportive/Palliative Care Center
|
N/A | |
Active, not recruiting |
NCT03287492 -
RCT of QPS vs General Information Sheet
|
N/A | |
Completed |
NCT06269276 -
Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
|
||
Completed |
NCT03675217 -
Physical Exercise Program for Family Caregivers of Dependent Patients
|
N/A | |
Not yet recruiting |
NCT05970471 -
Preferences of Patients Treated With Oral Cancer Drugs and Informal Caregivers for Pharmaceutical Consultation in Hospital
|
||
Completed |
NCT04587583 -
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
|
Phase 1/Phase 2 | |
Completed |
NCT03689179 -
Virtual Coaching to Maximize Dementia Caregivers' Respite Time Use
|
N/A | |
Enrolling by invitation |
NCT05068765 -
The Effect of the Psychoeducation Program on the Subjective Well-being of Caregivers
|
N/A | |
Completed |
NCT05441384 -
It's Time to Address Fear of Cancer Recurrence in Family Caregivers: Online Version of the Fear Of Recurrence Therapy
|
N/A | |
Active, not recruiting |
NCT03267524 -
Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers
|
N/A | |
Completed |
NCT02603367 -
COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer
|
N/A | |
Completed |
NCT04747210 -
Contextual Coaching Versus Training Workshop for Assistants in Special Education.
|
N/A | |
Completed |
NCT04058886 -
Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers
|
N/A | |
Completed |
NCT03775616 -
Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers
|
N/A | |
Completed |
NCT03528863 -
Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
|
N/A | |
Completed |
NCT06132022 -
The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care
|
N/A | |
Not yet recruiting |
NCT06111794 -
The REACH Intervention for Caregivers of Veterans and Service Members With TBI
|
N/A | |
Withdrawn |
NCT04085081 -
Physical Activity Intervention Before and After Surgery in Older Adults With Lung Cancer and Their Family Caregivers
|
N/A | |
Completed |
NCT03032250 -
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
|
N/A | |
Not yet recruiting |
NCT05245305 -
The Effect of Mindfulness-Based Stress Reduction Program
|
N/A |