Integrating Family Caregiver Support Into Cancer Clinical Trials

NCT ID: NCT03069287

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2023-02-14

Brief Summary

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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.

Detailed Description

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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. This study will allow us to examine the benefit of adding a personalized support program for the family caregiver of a patients participating in a cancer clinical trial. Findings will assist in strengthening patient/caregiver-centered care management and support programs developed to enhance the quality of life of patients with cancer and the caregivers, reduce barriers to clinical recruitment, and improve retention in clinical trials.

Conditions

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Cancer Clinical Trials Caregivers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patient-caregiver dyads

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

Group Type EXPERIMENTAL

Benjamin Rose Institute (BRI) Care Consultation™ Program

Intervention Type BEHAVIORAL

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.

Interventions

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Benjamin Rose Institute (BRI) Care Consultation™ Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint John's Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Santa Monica, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27921222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28189161 (View on PubMed)

Other Identifiers

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JWCI-17-0102

Identifier Type: -

Identifier Source: org_study_id

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