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

2 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

150

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • California
      • San Francisco, California, Stati Uniti, 94143
        • University of California, San Francisco
        • Contatto:
        • Investigatore principale:
          • Mark Zhao, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Participants with rectal cancer
Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF.
Altro: Quality of Life Surveys
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) & Decisional Regret Scale (DRS)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of scheduled MyChart survey events completed
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Francisco

Investigatori

  • Investigatore principale: Mark Zhao, MD, University of California, San Francisco

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 ottobre 2026

Completamento primario (Stimato)

30 novembre 2027

Completamento dello studio (Stimato)

30 novembre 2027

Date di iscrizione allo studio

Primo inviato

2 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

9 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 264516
  • NCI-2026-06213 (Identificatore di registro: NCI Clinical Trials Reporting System (CTRP))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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