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Stepped Collaborative Care Intervention for Cancer Patients and Their Family Caregivers (CARES-Lite Trial)
N/A
Waitlist Available
Led By Jennifer L Steel
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 6 months
Awards & highlights
CARES-Lite Trial Summary
This trial tested if a web program improves symptoms of depression, pain, and fatigue for advanced cancer patients, and reduces stress and depression, and fewer CVD risk factors in caregivers.
Eligible Conditions
- Sleep
- Depression
- Cancer
- Pain
- Fatigue
CARES-Lite Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver Quality of Life
Mental Depression
Fatigue
+4 moreCARES-Lite Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stepped collaborative care interventionExperimental Treatment1 Intervention
The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.
Group II: Enhanced Usual CareActive Control1 Intervention
Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stepped collaborative care intervention
2016
N/A
~460
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,397 Total Patients Enrolled
14 Trials studying Sleep
2,046 Patients Enrolled for Sleep
Jennifer L SteelPrincipal InvestigatorUPMC Department of Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Caregivers must be at least 21 years old and able to speak English fluently. They should not have any signs of mental health issues like confused thoughts, false beliefs, hearing or seeing things that aren't there, or thoughts of harming oneself.You are under 21 years old, have difficulty speaking English fluently, or show signs of mental health issues like disorganized thoughts, false beliefs, hearing or seeing things that aren't there, or thoughts of harming yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Stepped collaborative care intervention
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Patient Testimony for trial: Trial Name: NCT05601206 — N/A
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