CancerNCT07068477
Adaptation of a Values Assessment Tool
A study testing Values Assessment Tool in people with Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Metastatic Breast Cancer
- What is being tested?
- Values Assessment Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Diagnosed with metastatic breast cancer.
- Understand and read English.
- Receive care or anticipate receiving care at the North Carolina Cancer Hospital ambulatory cancer clinic or affiliated community cancer clinic.
- Able to understand and participate in study procedures for length of study.
Who cannot join
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Unable to provide consent, unable to communicate verbally.
- Unable to understand or read English.
- Enrolled in hospice care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)
The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician.
Read the detailed description
Incorporating patient values into shared decision-making is essential for individuals diagnosed with metastatic cancer. This is especially critical for women who identify as Black/African American, Latinx/Hispanic, or American Indian/Alaskan Native, as research indicates these groups face a higher risk of poor prognostic communication, worse health outcomes, and increased likelihood of metastatic cancer diagnoses compared to non-Hispanic White adults.
Black/African American women in the South, including North Carolina, experience the highest breast cancer mortality rates in the United States. In North Carolina, the majority of women diagnosed with metastatic breast cancer (mBC) are either non-Hispanic White (159 per 100,000) or Black/African American (164 per 100,000). This study aims to ensure that at least 40% of participants are Black/African American women.
While the Short Graphic Values History (SGVH) tool has been used in general ambulatory care, it has not been tested or adapted for use in cancer care settings. Based on interviews with individuals living with mBC and their care partners, a new Values Assessment Tool (VAsT) has been developed for integration into cancer care.
This single-arm prospective study will enroll 40 women with mBC and their caregivers. Baseline data will be collected at diagnosis, followed by deployment of the VAsT in clinic settings. Follow-up feedback will be obtained to assess real-world usability and relevance of the tool in supporting shared decision-making in cancer care.
- Conditions
- Cancer, Metastatic Breast Cancer
- Being tested
- Values Assessment Tool
- Keywords
- African American, Latinx, Alaskan Native, Short Graphic Values History
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values Assessment ToolBehavioural
The Values Assessment Tool was provided to the participants at baseline and every clinic visit for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Values assessment tool | Experimental | Participants are assessed at baseline and every clinic visit for 3 months Receives: Behavioral: Values Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional engagement
Values Assessment Tool participants will be assessed using decisional engagement, Patient-Centered Communication in Cancer Care (PCC-Ca) 36.
Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
Measured: Baseline and every clinic visit for 3 months
Decisional conflict
Decisional Conflict will be assessed using the Decisional Conflict Scale (10-item low literacy version).
Scoring and Interpretation: Items are given a score value of: 0 = 'yes'; 2 = 'unsure'; 4 = 'no'
Total Score: 10 items [items 1-10 inclusive] are: a) summed; b) divided by 10; and c) multiplied by 25.
Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]
Measured: Baseline and every clinic visit for 3 months
Communication perceptions
Communication perceptions will be assessed using Patient-Centered Communication in Cancer Care (PCC-Ca) 36.
Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
Measured: Baseline and every clinic visit for 3 months
Secondary outcomes (2)
The number of participants who started and completed
The number of participants who started and completed using the Values Assessment Tool will be presented.
Measured: Baseline and 3 months
Shared decision making evaluation
Shared decision-making will be evaluated through a combination of qualitative semi-structured interviews and audio recordings of clinical encounters with enrolled patient participants, conducted both before and after the use of the Short Graphic Values History (SGVH) tools.
Open-ended feedback from participants will undergo content analysis to identify key themes. These insights will be used to prioritize recommendations for refining the next iteration of the SGVH tool intervention.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start5 Jan 2023
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorinda Coombs, PhD, FNP-BC, AOCNP, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068477
- Sponsor's protocol ID
- LCCC2201
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values Assessment Tailored for Women With Metastatic Breast Cancer and Their Caregivers: Adaptation and Pilot Study of a Values Assessment Tool (VAsT)
- ClinicalTrials.gov ID
- NCT07068477
- Acronym / sponsor ID
- LCCC2201
- Conditions
- Cancer, Metastatic Breast Cancer
- Keywords
- African American, Latinx, Alaskan Native, Short Graphic Values History
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician.
Detailed description
Incorporating patient values into shared decision-making is essential for individuals diagnosed with metastatic cancer. This is especially critical for women who identify as Black/African American, Latinx/Hispanic, or American Indian/Alaskan Native, as research indicates these groups face a higher risk of poor prognostic communication, worse health outcomes, and increased likelihood of metastatic cancer diagnoses compared to non-Hispanic White adults.
Black/African American women in the South, including North Carolina, experience the highest breast cancer mortality rates in the United States. In North Carolina, the majority of women diagnosed with metastatic breast cancer (mBC) are either non-Hispanic White (159 per 100,000) or Black/African American (164 per 100,000). This study aims to ensure that at least 40% of participants are Black/African American women.
While the Short Graphic Values History (SGVH) tool has been used in general ambulatory care, it has not been tested or adapted for use in cancer care settings. Based on interviews with individuals living with mBC and their care partners, a new Values Assessment Tool (VAsT) has been developed for integration into cancer care.
This single-arm prospective study will enroll 40 women with mBC and their caregivers. Baseline data will be collected at diagnosis, followed by deployment of the VAsT in clinic settings. Follow-up feedback will be obtained to assess real-world usability and relevance of the tool in supporting shared decision-making in cancer care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Values assessment tool | Experimental | Behavioral: Values Assessment ToolParticipants are assessed at baseline and every clinic visit for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosed with metastatic breast cancer.
- Understand and read English.
- Receive care or anticipate receiving care at the North Carolina Cancer Hospital ambulatory cancer clinic or affiliated community cancer clinic.
- Able to understand and participate in study procedures for length of study.
Key exclusion criteria (4 listed)
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- Unable to provide consent, unable to communicate verbally.
- Unable to understand or read English.
- Enrolled in hospice care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Values Assessment ToolThe Values Assessment Tool was provided to the participants at baseline and every clinic visit for 3 months | Behavioural | Values assessment tool |
Primary outcome
Decisional engagement
Time frame: Baseline and every clinic visit for 3 months
Values Assessment Tool participants will be assessed using decisional engagement, Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
Decisional conflict
Time frame: Baseline and every clinic visit for 3 months
Decisional Conflict will be assessed using the Decisional Conflict Scale (10-item low literacy version). Scoring and Interpretation: Items are given a score value of: 0 = 'yes'; 2 = 'unsure'; 4 = 'no' Total Score: 10 items [items 1-10 inclusive] are: a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]
Communication perceptions
Time frame: Baseline and every clinic visit for 3 months
Communication perceptions will be assessed using Patient-Centered Communication in Cancer Care (PCC-Ca) 36. Each item included in the PCC-Ca instrument consists of a question stem and five response options. The response options are scored from 1 to 5, with higher scores representing better communication; for example, where 1 = Never and 5 = Always. There are no reverse-scored items. Some items have a sixth "does not apply" option. This response is not scored.
2 secondary outcomes
The number of participants who started and completed
Time frame: Baseline and 3 months
Shared decision making evaluation
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorinda Coombs, PhD, FNP-BC, AOCNP principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Values Assessment Tool in people with Cancer and Metastatic Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional engagement (time frame: Baseline and every clinic visit for 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.