Pancreas Cancer
Conditions
Brief summary
Pancreatic cancer has a rising incidence and poor survival. Early detection in high-risk individuals may substantially improve outcomes. Although guidelines recommend screening for individuals with hereditary cancer syndromes or certain genetic variants, pancreatic cancer screening remains uncertain due to limited evidence of mortality benefit, unclear screening strategies, potential harms, resource requirements, and low adherence. Shared decision-making between patients and providers is therefore essential, but no decision aid currently exists to support pancreatic cancer screening decisions. This record covers Aim 2, which will evaluate the acceptability, feasibility, and implementation of an electronic decision support tool designed to improve shared decision-making, value-concordant care, and screening adherence. The pilot study will also provide training in clinical trial methodology and support development toward an independent research career.
Interventions
BEHAVIORALElectronic Decision Support Tool
Participants will use an electronic decision support tool designed to facilitate shared decision-making about pancreatic cancer screening. The pilot study will evaluate the tool's acceptability, feasibility, and implementation in clinical practice.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
block randomization with 3:1 allocation will be used at the time of consent.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults who are eligible for pancreatic cancer screening according to current National Comprehensive Cancer Network guidelines. * Not currently enrolled in a pancreatic cancer screening program. * Referred to or previously seen at the UNC High Risk GI Cancer Clinic. * English-speaking. * Able and willing to provide informed consent.
Exclusion criteria
* Currently enrolled in a pancreatic cancer screening program. * Does not meet pancreatic cancer screening eligibility criteria according to National Comprehensive Cancer Network guidelines. * Unable or unwilling to provide informed consent. * Non-English speaking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the decision support tool | Up to 3 months | Participant-reported acceptability of the electronic decision support tool, assessed using a validated acceptability measures: acceptability of intervention measure (AIM) and intervention appropriateness measure (IAM). The minimum score for both measures is 4 (all items rated "1 - Completely Disagree") and the maximum score is 20 (all items rated "5 - Completely Agree"). |
| Feasibility, Barriers, and Facilitators of Implementing the Decision Support Tool - Recruitment Rate | Up to 3 months | Recruitment rate, defined as the proportion and number of eligible participants who enroll in the study, will be used to assess the feasibility of integrating and implementing the electronic decision support tool in clinical practice. |
| Feasibility, barriers, and facilitators of implementing the decision support tool - retention rate | Up to 3 months | Retention rate, defined as the number and proportion of enrolled participants who complete use of the electronic decision support tool and all study-related assessments, will be used to assess the feasibility of integrating and implementing the tool in clinical practice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in score on 5 question knowledge assessment | Up to 3 months | Difference between participants' post-visit and pre-visit knowledge scores regarding the screening decision. Change in knowledge will be defined as the difference between participants' post-visit and pre-visit knowledge scores on a five-item knowledge assessment, calculated as the post-knowledge score minus the pre-knowledge score. Pre- and post-knowledge scores will be calculated by summing correct answers (equal to 1) and incorrect or incomplete responses (equal to 0). The assessment will be administered immediately before and after the clinic visit. |
| Rate of Decision-Concordant Care | Up to 3 months | If the participant undergoes the screening test documented during the clinic visit within 3 months of the visit, this will be considered decision-concordant care. The rate of decision concordant care will be equal to the number of participants who underwent decision-concordant care divided by the total number of participants in the study. Medical record/chart review will be used for measurements |
| Duration of the clinic visit | Up to 3 months | Duration of the clinic visit will be measured as the duration of the index clinic visit using available clinical or electronic medical record timestamps. This measure will be used to evaluate whether the intervention affects the amount of time required to complete the clinic visit. |
| Patient-reported assessment of shared decision-making quality -1 | Up to 3 months | Patient-reported assessment of the quality of the shared decision-making process, including the extent to which patients received information about available options, understood the benefits and risks of those options, and had their preferences considered in the decision. It will be measured using the collaboRATE questionnaire, administered immediately following the clinic visit and using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). The SDM-Q-9 measures the extent to which patients perceive that key components of shared decision-making occurred during the clinical encounter. The minimum score for the SDM-Q-9 is 0 (all items rated "0 - Completely Disagree") and the maximum score is 45 (all items rated "5 - Completely Agree"). Higher scores indicate a patient perception of better shared decision making. It will be administered immediately following the clinic visit. |
| Patient-reported assessment of shared decision-making quality -2 | Up to 3 months | Patient-reported perception of the extent to which shared decision-making occurred during the clinic visit will be additionally be assessed using the 3 question collaboRATE questionnaire. The collaboRATE questionnaire measures the extent to which patients received information about available options, understood the benefits and risks of those options, and had their preferences considered. The minimum score for collaborate is 0 (all items rated "0 - No Effort") and the maximum score is 12 (all items rated "4 - Every Effort"). T the collaboRATE questionnaire will be administered immediately following the clinic visit. |
| Patient-reported assessment of decisional conflict | Up to 3 months | Patient-reported uncertainty or conflict regarding the screening decision, including factors such as informed choice, will be assessed using the 16 question decisional Conflict Scale (DCS). The minimum score for the DCS is 0 (no decisional conflict) and the maximum score is 100 (extremely high decisional conflict). The DCS will be administered immediately following the clinic visit. |
Countries
United States
Contacts
CONTACTTrevor Barlowe, MD
PRINCIPAL_INVESTIGATORTrevor Barlowe, MD
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed