Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Quality of Life Surveys
Other interventionPatient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) \& Decisional Regret Scale (DRS)
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Participants with rectal cancer1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: