Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer

PRIMARY OBJECTIVES:

• Evaluate feasibility and adherence of participant-reported outcomes through UCSF MyChart.
• Evaluate changes in health-related quality of life over the course of rectal cancer treatment.

SECONDARY OBJECTIVES:

• Evaluate longitudinal changes in decisional regret over the course of rectal cancer treatment.
• Evaluate the association between health-related quality of life and decisional regret over the course of rectal cancer treatment.
• Evaluate differences in health-related quality of life and decisional regret trajectories by treatment stage and modality.
• Evaluate patterns of survey completion and adherence to the MyChart survey workflow.

OUTLINE: This is a prospective observational study of adults with non-metastatic rectal cancer receiving care at University of California, San Francisco (UCSF). Participants will complete patient-reported outcome measures through UCSF MyChart during the course of their treatment and will be follow up to 24 month post treatment.

Inclusion criteria

• Adults age 18 years or older meet all of the following.
• Documented rectal cancer diagnosis (for example, ICD-10-CM C20) without metastatic disease at the initial study eligibility assessment.
• Established follow-up with UCSF colorectal surgery, medical oncology, or radiation oncology, generally defined as at least two encounters more than 1 month apart.
• Active UCSF MyChart access by enrollment and ability to personally complete the electronic consent and surveys, independently or with reasonable technical or accessibility assistance that does not answer questions on the participant's behalf. Individuals identified through PRP direct mail who do not yet use MyChart may activate MyChart before enrollment.
• Able to read and complete the currently validated English-language study materials.
• Able to provide informed consent and HIPAA authorization.

Exclusion criteria

• Metastatic disease at the initial eligibility assessment.
• Unable or unwilling to activate and personally use UCSF MyChart before enrollment, even with reasonable technical or accessibility assistance.
• Unable to complete the English-language consent and validated instruments. This initial pilot is limited to English because validated translations and translated automated workflows are not yet available.
• No UCSF clinical encounter for more than 6 months or otherwise lost to follow-up.- Unable or unwilling to provide informed consent and HIPAA authorization.
• Prisoner at enrollment. If a participant becomes incarcerated or loses decision-making capacity after enrollment, active survey collection will stop.

Participants who develop metastatic progression after enrollment are not treated as screen failures; they will receive one final general ABCRC module and then exit the automated survey sequence.