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

2. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

150

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94143
        • University of California, San Francisco
        • Kontakt:
        • Hauptermittler:
          • Mark Zhao, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Participants with rectal cancer
Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF.
Sonstiges: Quality of Life Surveys
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) & Decisional Regret Scale (DRS)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of scheduled MyChart survey events completed
Zeitfenster: 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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

31. Oktober 2026

Primärer Abschluss (Geschätzt)

30. November 2027

Studienabschluss (Geschätzt)

30. November 2027

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. September 2026

Zuerst gepostet (Tatsächlich)

9. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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