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Eine Studie entspricht den Filterkriterien
Kartenansicht
Feasibility of Remote Activity Assessment and PRO Collection Among Transgender Cancer Survivors (STRIDE)
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05391217 (STRIDE) ist eine beobachtungsstudie zur Untersuchung von Neoplasmen, Chronische Krankheit und hat den Status offene rekrutierung. Die Studie startete am 1. Februar 2023 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Cedars-Sinai Medical Center ist der Abschluss für 1. Juli 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. August 2024 aktualisiert.
Kurzbeschreibung
Prospective observational feasibility study to evaluate the role of wearable activity monitors to determine the feasibility and acceptability of remote monitoring using wearable technology and PROs to monitor fatigue and physical function in transgender cancer patients and survivors.
Ausführliche Beschreibung
Transgender cancer survivors are a diverse population who currently suffer from cancer-related disparities. Enrolled subjects will receive wearable activity devices to help understand how their daily activity (e.g., daily step counts, stairs climbed) and sleep levels are affected by their symptoms and treatment side-effects, including fatigue, physical functioning, emotional well-being, sleep quality, and quality of life over the 2-week course of the study. Qualitative interviews will be conducted to gain a deeper understanding of barriers to physical activity and their perceived relationships with their cancer history, treatment symptoms and gender affirming hormone therapy.
Offizieller Titel
Study to Remotely Monitor Activity in Transgender Cancer Survivors
Erkrankungen
NeoplasmenChronische KrankheitWeitere Studien-IDs
- STRIDE
- STUDY00001826
NCT-Nummer
Studienbeginn (tatsächlich)
2023-02-01
Zuletzt aktualisiert
2024-08-27
Studienende (vorauss.)
2025-07-01
Geplante Rekrutierung
20
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Transgender people with history of cancer Self-reported cancer history and/or treatment for cancer within the last 5 years. | Remote Assessment of Patient Reported Outcomes and Daily Activity Electronic patient-reported outcomes (NIH PROMIS) will be collected and combined with remotely monitored physical activity, heart rate, and sleep, as measured with a Fitbit (Sense). |
Transgender people without history of cancer People living with other chronic conditions | Remote Assessment of Patient Reported Outcomes and Daily Activity Electronic patient-reported outcomes (NIH PROMIS) will be collected and combined with remotely monitored physical activity, heart rate, and sleep, as measured with a Fitbit (Sense). |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Feasibility of Remote Activity Assessment and PRO Collection | Proportion of patients who consent to participate in the research study and complete the baseline fatigue assessment, where a proportion of 50% will be considered feasible. | 2 weeks |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity | Qualitative outcome, as obtained through semi-structured interviews | 2 weeks |
Average daily step count (steps/day) | Average daily step count over the study period will be calculated from wearable activity monitor | 2 weeks |
24-Hour Movement | A composite of average time spent in physical activity (light/moderate/vigorous), time sedentary, and sleep will be calculated following the 24-hour movement continuum guidelines and average values will be obtained over the study period. | 2 weeks |
Patient-reported health and well-being | NIH PROMIS surveys (Likert scale range 0-5, where 5 is the highest level of well-being) at baseline and end of study | 2 weeks |
Patient-reported mood | Mean NIH PROMIS anxiety, depression and stress scores (range 0-5), converted to T-scores (mean 50, SD 10) at each timepoints. | up to 2 weeks |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- Self-identifies as transgender person with a history of cancer or receiving treatment for cancer in the last five years from screening for the current study (case) OR self-identifies as transgender person without a history of cancer (control)
- 18 years or older
- Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- Access to a device (e.g., smartphone, tablet, iPhone) that has the capability to sync to the Fitbit
- Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
- Can read and understand English, Spanish, or Tagalog (for participant surveys and interviews)
- Informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Any person that does not meet the listed criteria above
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment*. However, removable hearing aids are permitted.
Cedars-Sinai Medical CenterVerantwortliche Partei
Gillian Gresham, Hauptprüfer, Assistant Professor, Cedars-Sinai Medical Center
Zentrale Studienkontakte
Kontakt: Gillian Gresham, 310-423-3341, [email protected]
1 Studienstandorte in 1 Ländern
California
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Katie Barnhill, BS, Kontakt, 310-423-3341, [email protected]
Robert Haile, DrPH, Prüfarzt
Zulfikarali Surani, Prüfarzt
Offene Rekrutierung