Integrating Family Caregiver Support Into Cancer Clinical Trials

Study Overview
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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.

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

Conditions
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Cancer, Clinical Trials, Caregivers

Intervention / Treatment
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* Behavioral: Benjamin Rose Institute (BRI) Care Consultation™ Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-caregiver dyads<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |