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Trial record 7 of 133 for:    depression pittsburgh | Recruiting, Not yet recruiting, Available Studies

Collaborative Care Intervention for Cancer Caregivers

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified October 2016 by Jennifer Steel, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Jennifer Steel, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02944136
First received: October 18, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers. Biobehavioral factors will include assessment of changes in health behaviors and biomarkers of inflammation. The investigators will also include measures metabolic abnormalities and clinical markers of CVD. The investigators expect few cardiac events during the study period. The investigators will also measure other health outcomes but CVD risk factors will be the focus of the study.

Condition Intervention
Depression Advanced Cancer Behavioral: enhanced usual care Behavioral: stepped collaborative care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
Official Title: Collaborative Care Intervention for Cancer Caregivers

Resource links provided by NLM:


Further study details as provided by Jennifer Steel, University of Pittsburgh:

Primary Outcome Measures:
  • Caregiver Quality of Life Questionnaire [ Time Frame: change from baseline at 4 months, 8 months and 12 months ]
    Caregiver Quality of Life Index

  • Caregiver's Perceived Stress Questionnaire [ Time Frame: change from baseline at 4 months, 8 months and 12 months ]
    Perceived Stress

  • Caregiver's Depression Questionnaire [ Time Frame: change from baseline at 4 months, 8 months and 12 months ]
    CES-D


Secondary Outcome Measures:
  • Caregiver's IL-6, TNFα, fibrinogen, CRP [ Time Frame: change from baseline at 4 months, 8 months and 12 months ]
    mg/dl


Estimated Enrollment: 40
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enhanced Usual Care
Referred to a therapist and/or psychiatrist in their home town depending on the type of treatment they prefer (e.g., behavioral and/or medication)
Behavioral: enhanced usual care
usual care from health providers
Other Name: control
Experimental: stepped collaborative care
At least biweekly contact from a care coordinator by phone and face-to- face visits occurring approximately every 2 months during the patients outpatient visits or treatment, and 24/7 access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.
Behavioral: stepped collaborative care
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other Name: treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient:

    1. Expected survival < 2 years
    2. Age >21 years
    3. Living with spouse or intimate partner

Caregiver:

  1. Age >21 years
  2. CES-D score >=16
  3. Living with a spouse or intimate partner with cancer

Exclusion Criteria:

  • Patient:

    1. Lack of fluency in written and spoken English
    2. Cannot identify spouse or intimate partner
    3. Evidence of thought disorder, suicidal ideation, hallucinations or delusions

Caregiver:

  1. Lack of fluency in written and spoken English
  2. Taking corticosteroids or engaged in shift work
  3. Evidence of thought disorder, suicidal ideation, hallucinations or delusions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02944136

Contacts
Contact: Jennifer L. Steel, PhD 4126523959 steeljl@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh's Medical Center Montefiore Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer L. Steel, PhD    412-624-3959    steeljl@upmc.edu   
UPMC Presbyterian Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer L. Steel, PhD    412-624-3959    steeljl@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jennifer L. Steel, PhD UPMC departemnt of surgery
  More Information

Responsible Party: Jennifer Steel, Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02944136     History of Changes
Other Study ID Numbers: PRO16080223
Study First Received: October 18, 2016
Last Updated: October 24, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Jennifer Steel, University of Pittsburgh:
cancer
stepped collaborative care intervention
depression
quality of life
stress
dyadic function
spousal or intimate caregiver

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 22, 2017