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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 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 6 months for reporting.

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 more

CARES-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
1,729 Previous Clinical Trials
16,307,450 Total Patients Enrolled
14 Trials studying Sleep
2,046 Patients Enrolled for Sleep
Jennifer L SteelPrincipal InvestigatorUPMC Department of Surgery

Media Library

Enhanced Usual Care Clinical Trial Eligibility Overview. Trial Name: NCT05601206 — N/A
Sleep Research Study Groups: Stepped collaborative care intervention, Enhanced Usual Care
Sleep Clinical Trial 2023: Enhanced Usual Care Highlights & Side Effects. Trial Name: NCT05601206 — N/A
Enhanced Usual Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601206 — N/A
Sleep Patient Testimony for trial: Trial Name: NCT05601206 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available in this study at the moment?

"Clinicaltrials.gov indicates that the study, which was initially available on 14 November 2022, is still recruiting participants. It has been revised most recently on 21 November of the same year."

Answered by AI

Is it permissible for those younger than sixty to participate in this experiment?

"This clinical investigation requires that participants are aged 21 or higher, with the upper limit set at 100 years old."

Answered by AI

How many patients have been selected to participate in this experiment?

"Affirmative. Clinicaltrials.gov holds information on this trial that is currently recruiting patients, which was first posted on November 14th 2022 and last updated a week later. A total of 40 study participants are needed from two medical centres for completion."

Answered by AI

Might I be a potential participant in this research?

"This clinical trial is searching for 40 individuals, aged between 21 and 100 years old, who suffer from fatigue. Furthermore, participants must be diagnosed with hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast/ovarian/colorectal cancer metastasized to the liver; they should also not present any signs of mental disorder such as delusions or suicidal thoughts. Lastly, if a spouse of an advanced cancer patient being evaluated at UPMC’s Liver cancer Center meets the above criteria and is over 21 years old then he/she can participate in this study."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
What site did they apply to?
University of Pittsburgh's Medical Center Montefiore Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

The study seems like a good addition and resource to help, not only myself, but my husband/caregiver through my cancer journey.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
Jennifer Steel 2023. "Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05601206.
~21 spots leftby Feb 2025
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