Integrating Family Caregiver Support Into Cancer Clinical Trials

Cancer Clinical Trial

Official title:

Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03069287
• Other study ID #: JWCI-17-0102
• Status: Withdrawn
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: February 14, 2023

Study information

• Verified date: April 2023
• Source: Saint John's Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Caregivers
• Clinical Trials

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute at Providence Saint John's Health Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Saint John's Cancer Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score	Assesses patient quality of life. There are 27 questions, each of which is answered using a 5-point scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state.	1 year
Secondary	Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores	The Patient Reported Outcome-Common Toxicity Criteria for Adverse Events (PRO-CTCAE) assesses patient quality of life. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. Responses for each attribute (frequency, severity, and/or interference of symptoms) are scored from 1 to 5 with 1+ mild and 5 = death.; - Mild; - Moderate; - Severe; - Life-threatening; - Death	1 year