NCT02944136

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

6.3 years

First QC Date

October 18, 2016

Last Update Submit

December 11, 2024

Conditions

DepressionAdvanced Cancer

Keywords

cancerstepped collaborative care interventiondepressionquality of lifestressdyadic functionspousal or intimate caregiver

Outcome Measures

Primary Outcomes (3)

  • Caregiver Quality of Life Questionnaire

    Caregiver Quality of Life Index

    change from baseline at 4 months, 8 months and 12 months

  • Caregiver's Perceived Stress Questionnaire

    Perceived Stress

    change from baseline at 4 months, 8 months and 12 months

  • Caregiver's Depression Questionnaire

    CES-D

    change from baseline at 4 months, 8 months and 12 months

Secondary Outcomes (1)

  • Caregiver's IL-6, TNFα, fibrinogen, CRP

    change from baseline at 4 months, 8 months and 12 months

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

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

stepped collaborative care

EXPERIMENTAL

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

Interventions

enhanced usual careBEHAVIORAL

usual care from health providers

Also known as: control
Enhanced Usual Care
stepped collaborative careBEHAVIORAL

Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional

Also known as: treatment
stepped collaborative care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient:
  • Expected survival \< 2 years
  • Age \>21 years
  • Living with spouse or intimate partner
  • Caregiver:
  • Age \>21 years
  • CES-D score \>=16
  • Living with a spouse or intimate partner with cancer

You may not qualify if:

  • Patient:
  • Lack of fluency in written and spoken English
  • Cannot identify spouse or intimate partner
  • Evidence of thought disorder, suicidal ideation, hallucinations or delusions
  • Caregiver:
  • Lack of fluency in written and spoken English
  • Taking corticosteroids or engaged in shift work
  • Evidence of thought disorder, suicidal ideation, hallucinations or delusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh's Medical Center Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionNeoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jennifer L. Steel, PhD

    UPMC departemnt of surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 25, 2016

Study Start

December 1, 2016

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)