Rectal CancerNCT07811128
Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer
An observational study of Rectal Cancer and Non Metastatic Rectal Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Non Metastatic Rectal Cancer
- What is being tested?
- Quality of Life Surveys
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Laleh Foroutani, MD, 415-299-9424, laleh.foroutani@ucsf.edu
Mark Zhao, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Rectal Cancer, Non Metastatic Rectal Cancer
- Being tested
- Quality of Life Surveys
- Keywords
- Health-related quality of life (HRQoL)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life SurveysOther
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) \& Decisional Regret Scale (DRS)
| Study group | Role | What they receive |
|---|---|---|
| Participants with rectal cancer | Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF. Receives: Other: Quality of Life Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Zhao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811128
- Sponsor's protocol ID
- 264516
- Other IDs
- NCI-2026-06213
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer
- ClinicalTrials.gov ID
- NCT07811128
- Acronym / sponsor ID
- 264516
- Conditions
- Rectal Cancer, Non Metastatic Rectal Cancer
- Keywords
- Health-related quality of life (HRQoL)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with rectal cancer | – | Other: Quality of Life SurveysParticipants with non-metastatic rectal cancer and who are receiving treatment at UCSF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Quality of Life SurveysPatient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) \& Decisional Regret Scale (DRS) | Other | Participants with rectal cancer |
Primary outcome
Proportion of scheduled MyChart survey events completed
Time frame: Up top 12 months
The proportion of scheduled MyChart survey events completed by participants will be summarized, with a target completion rate of at least 75%.
Change in mean ABCRC total and module-specific scores over time.
Time frame: Up to 12 months
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.
4 secondary outcomes
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Time frame: Up to 12 months
Association between ABCRC and DRS scores over the course of treatment
Time frame: Up to 12 months
Change in mean ABCRC and DRS scores over time by treatment characteristics
Time frame: Up to 12 months
Patterns of survey nonresponse, missingness, and workflow adherence
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mark Zhao, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Non Metastatic Rectal Cancer, run by University of California, San Francisco 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laleh Foroutani, MD ((415) 299-9424, laleh.foroutani@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of scheduled MyChart survey events completed (time frame: Up top 12 months). The study lists 2 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 9 Sep 2026.