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

2 september 2026 bijgewerkt door: University of California, San Francisco
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

150

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94143
        • University of California, San Francisco
        • Contact:
        • Hoofdonderzoeker:
          • Mark Zhao, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Participants with rectal cancer
Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF.
Ander: Quality of Life Surveys
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) & Decisional Regret Scale (DRS)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of scheduled MyChart survey events completed
Tijdsspanne: 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%.
Up top 12 months
Change in mean ABCRC total and module-specific scores over time.
Tijdsspanne: 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.
Up to 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Tijdsspanne: Up to 12 months
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.
Up to 12 months
Association between ABCRC and DRS scores over the course of treatment
Tijdsspanne: Up to 12 months
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.
Up to 12 months
Change in mean ABCRC and DRS scores over time by treatment characteristics
Tijdsspanne: Up to 12 months
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.
Up to 12 months
Patterns of survey nonresponse, missingness, and workflow adherence
Tijdsspanne: Up to 12 months
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.
Up to 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Francisco

Onderzoekers

  • Hoofdonderzoeker: Mark Zhao, MD, University of California, San Francisco

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 oktober 2026

Primaire voltooiing (Geschat)

30 november 2027

Studie voltooiing (Geschat)

30 november 2027

Studieregistratiedata

Eerst ingediend

2 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2026

Eerst geplaatst (Werkelijk)

9 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 264516
  • NCI-2026-06213 (Register-ID: NCI Clinical Trials Reporting System (CTRP))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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