NCT03069287

Brief Summary

The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4.6 years

First QC Date

February 27, 2017

Last Update Submit

April 11, 2023

Conditions

CancerClinical TrialsCaregivers

Outcome Measures

Primary Outcomes (2)

  • Absolute change in the Caregiver Reaction Assessment (CRA) score

    Caregiver Reaction Assessment (CRA) will be used to measure caregiver burden. The instrument was designed as a questionnaire with Likert-type responses ranging from strongly agree (1) to strongly disagree. The 24 items form 5 distinct unidimensional subscales that include: family burden (lack of family support; 5 items), financial burden (struggle with bills; 3 items), health burden (caregivers' health decline; 4 items), schedule burden (disruption of daily tasks; 5 items), and caregiving esteem (7 items), a positive subscale that measures enjoyment and importance of caregiving. A higher score on the caregiver's esteem subscale indicates a more positive effect of caregiving while higher scores on the other subscales indicate greater negative effects of caregiving in those domains

    1 year

  • Absolute change in the scores for the assessment domains included in the Ben Rose Institute (BRI) care consultation program

    Assessment of multiple caregiver and patient domains addressed by the BRI Care Consultation program

    1 year

Secondary Outcomes (2)

  • Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score

    1 year

  • Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores

    1 year

Study Arms (1)

Patient-caregiver dyads

EXPERIMENTAL

Dyads will include family caregivers and patients with a diagnosis of cancer who agreed to participate in a therapeutic clinical trial.

Behavioral: Benjamin Rose Institute (BRI) Care Consultation™ Program

Interventions

Benjamin Rose Institute (BRI) Care Consultation™ ProgramBEHAVIORAL

The BRI Care Consultation™ can be delivered via face-to-face contact, telephone, mail, and/or email by a Care Consultant and caregiver who assists with daily activities, tasks, and health-related issues. BRI CareConsultation™ uses a secure, web-based Care Consultation Information System (CCIS) to guide the delivery of the intervention.

Patient-caregiver dyads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dyad must be at least 18 years of age,
  • patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial
  • caregiver is a self-identified primary caregiver,
  • able to speak, read, and understand English,
  • willing to participate in completion of surveys, and
  • co-residence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Related Publications (2)

  • Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.

    PMID: 27921222BACKGROUND

  • Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.

    PMID: 28189161BACKGROUND

MeSH Terms

Conditions

Neoplasms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

July 10, 2018

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)