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

N/ANot Yet RecruitingNCT07811128

University of California, San Francisco150 enrolled

Overview

Rectal cancer care is increasingly complex and may include systemic therapy, radiation therapy, surgery, or nonoperative watch-and-wait surveillance. These treatments can have both short- and long-term effects on bowel, urinary, sexual, and stoma-related function. Prior studies have often assessed quality of life and treatment decision experiences at a single time point or after one type of treatment, resulting in limited information about how patients' experiences change throughout their course of care. This study will evaluate health-related quality of life and experiences with treatment decisions among patients with non-metastatic rectal cancer using validated patient-reported outcome measures over the course of treatment.

PRIMARY OBJECTIVES: 1. Evaluate feasibility and adherence of participant-reported outcomes through UCSF MyChart. 2. Evaluate changes in health-related quality of life over the course of rectal cancer treatment. SECONDARY OBJECTIVES: 1. Evaluate longitudinal changes in decisional regret over the course of rectal cancer treatment. 2. Evaluate the association between health-related quality of life and decisional regret over the course of rectal cancer treatment. 3. Evaluate differences in health-related quality of life and decisional regret trajectories by treatment stage and modality. 4. 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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Rectal Cancer Non Metastatic Rectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults age 18 years or older meet all of the following. 2. Documented rectal cancer diagnosis (for example, ICD-10-CM C20) without metastatic disease at the initial study eligibility assessment. 3. Established follow-up with UCSF colorectal surgery, medical oncology, or radiation oncology, generally defined as at least two encounters more than 1 month apart. 4. 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. 5. Able to read and complete the currently validated English-language study materials. 6. Able to provide informed consent and HIPAA authorization. Exclusion Criteria: 1. Metastatic disease at the initial eligibility assessment. 2. Unable or unwilling to activate and personally use UCSF MyChart before enrollment, even with reasonable technical or accessibility assistance. 3. 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. 4. 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. 5. 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.

Outcomes

Primary Outcomes

Proportion of scheduled MyChart survey events completed

The proportion of scheduled MyChart survey events completed by participants will be summarized, with a target completion rate of at least 75%.

Time frame: Up top 12 months

Change in mean ABCRC total and module-specific scores over time.

Changes in Assessment of Burden in Colorectal Cancer (ABCRC) total and module-specific scores will be evaluated from enrollment and in relation to key treatment events. Statistical models that account for multiple measurements from the same participant will be used to evaluate changes in scores over time.

Time frame: Up to 12 months

Secondary Outcomes

Change in mean DRS score and proportion of participants with clinically significant decisional regret

Longitudinal changes in Decisional Regret Scale (DRS) scores will be evaluated over the course of treatment using statistical models that account for multiple measurements from the same participant. The proportion of participants with clinically significant decisional regret, defined as a DRS score greater than 50, will also be summarized.

Time frame: Up to 12 months

Association between ABCRC and DRS scores over the course of treatment

The relationship between Assessment of Burden in Colorectal Cancer (ABCRC) scores and Decisional Regret Scale (DRS) scores will be evaluated using repeated measurements collected from each participant. The analysis will examine whether participants with different levels of quality of life also report different levels of decisional regret, and whether changes in quality of life are related to changes in decisional regret within the same participant over time. Statistical methods that account for repeated measurements will be used.

Time frame: Up to 12 months

Change in mean ABCRC and DRS scores over time by treatment characteristics

Changes in ABCRC and DRS scores will be evaluated and compared among participants receiving different treatments, including surgery, watch-and-wait surveillance, treatment sequence, and surgical procedure. Statistical models that account for multiple measurements from the same participant will be used to evaluate differences in score changes over time.

Time frame: Up to 12 months

Patterns of survey nonresponse, missingness, and workflow adherence

Patterns of survey completion, nonresponse, missing data, and adherence to scheduled MyChart survey events will be described over the course of treatment. Missing information will be summarized and evaluated to understand how missing surveys or responses may vary over time and by participant or treatment characteristics.

Time frame: Up to 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts