Values Assessment Tool for Cancer

Overseen By Victoria Crowder

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Unable to consent, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool designed to help cancer patients and their caregivers make better decisions and communicate more effectively with doctors. It focuses on individuals dealing with metastatic breast cancer, which has spread to other parts of the body. Participants will use the Values Assessment Tool during regular clinic visits over three months. This trial suits English-speaking individuals receiving treatment at specific cancer clinics in North Carolina who can participate in the study activities. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could improve decision-making and communication in cancer care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this values assessment tool is safe?

Research has shown that the Values Assessment Tool is being developed to help cancer patients express their values more clearly to their doctors. This tool is neither a medication nor a surgery, so it carries no risk of physical side effects associated with those treatments.

The tool aims to enhance communication and decision-making between patients and healthcare providers. Since it focuses on dialogue and understanding, typical safety concerns of medical treatments do not apply. There are no reports of negative effects, as it facilitates discussions about care options rather than physically affecting the body.

In summary, participating in trials with this tool should be very safe, as it involves discussing and clarifying personal values rather than taking medication or undergoing a procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Values Assessment Tool is unique because it focuses on aligning cancer treatment plans with what matters most to the patient. Unlike current options that primarily concentrate on medical interventions like surgery, chemotherapy, or radiation, this tool helps ensure that patients' personal values and preferences are considered throughout their care. Researchers are excited about this approach because it has the potential to improve patient satisfaction and outcomes by fostering more personalized and meaningful healthcare experiences.

What evidence suggests that the Values Assessment Tool is effective for improving communication in cancer care?

Research has shown that tools for assessing personal values can enhance communication between cancer patients and their doctors. These tools enable patients to clearly express their priorities during treatment discussions, helping to avoid unnecessary, expensive, or unwanted treatments. This trial will evaluate the Values Assessment Tool, an experimental tool used to assess personal values at baseline and every clinic visit for 3 months. Reviews suggest that high-quality tools, such as the Graphic Values History Tools, effectively support patients with advanced cancer. Additionally, using these tools may improve overall survival and quality of life by ensuring care aligns with what patients value most. ^{1 6 7 8 9}

Who Is on the Research Team?

Lorinda Coombs, PhD, FNP-BC, AOCNP

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 years old diagnosed with metastatic breast cancer, who are receiving or expect to receive care at the North Carolina Cancer Hospital ambulatory clinic or its affiliated community clinics. Participants must be able to engage in study procedures throughout.

Inclusion Criteria

I can read and understand English.

I am receiving or plan to receive care at the North Carolina Cancer Hospital or its affiliated clinics.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection at diagnosis and deployment of the Values Assessment Tool in clinic settings

1 week

1 visit (in-person)

Treatment

Participants are assessed using the Values Assessment Tool at every clinic visit for 3 months

12 weeks

Multiple visits (in-person)

Follow-up

Follow-up feedback obtained to assess real-world usability and relevance of the tool

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Values Assessment Tool

Trial Overview The study aims to assess how a 'Values Assessment Tool' affects patient and caregiver feelings about decision-making conflicts and their communication with cancer doctors during treatment.

How Is the Trial Designed?

Group I: Values assessment tool Experimental Treatment 1 Intervention

Participants are assessed at baseline and every clinic visit for 3 months

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061624/

Co‐Creating and Refining a Values Assessment Tool ... This study aimed to inform the development of a values assessment tool to facilitate communication of priorities and preferences with oncology clinicians.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4980409/

The use and impact of quality of life assessment tools in ... This paper examines the use and impact of using QoL measures on health care of cancer patients within a clinical setting, particularly those with brain cancer.

3. cancernursingtoday.com cancernursingtoday.com/post/study-identifies-reliable-assessments-to-understand-document-patient-values

Study Identifies Reliable Assessments to Understand ... This review suggests that the Graphic Values History Tools are the highest-quality values assessments for patients with advanced cancer. These ...

4. ovid.com ovid.com/journals/cjon/fulltext/10.1188/23.cjon.525-531~values-assessment-tools-in-advanced-cancer-a-clinical

Values Assessment Tools in Advanced Cancer: A Clinical ... Values assessment in patients with advanced cancer helps to prevent care that is unnecessary, costly, or unwanted. This review described six values assessment ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822297

Patient-Reported Outcome Measures in Cancer Care The findings of this study suggest that the integration of PROMs into cancer care may improve overall survival and quality of life.

6. ons.org ons.org/pubs/article/29371/preview-download

Values Assessment Tools in Advanced Cancer No values assessment tools have been identified specifically for use in patients with advanced cancer. Downloaded on 11/09/2025. Single-user ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07068477

NCT07068477 | Adaptation of a Values Assessment Tool Values Assessment Tool participants will be assessed using decisional engagement, Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each ...

8. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(16)34221-8/fulltext

Validity and Reliability of Value Assessment Frameworks ... In this pilot study, eight panelists conducted value assessments of five advanced lung cancer drugs using the ASCO, ESMO, and ICER frameworks.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pon.70173

Co‐Creating and Refining a Values Assessment Tool ... To help patients identify and express their values to clinicians, we are developing a values assessment tool specifically for mBC.