Clinical trial NCT05910099: Taking a Look at Patient Experiences In Rectal Cancer Clinical Trials
Official title: Investigating Medical Research Trends in Rectal Cancer Clinical Study: Analyzing Factors Impacting Patient Involvement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rectal cancer who are actively participating in a clinical research, but have not yet completed enrollment and randomization.

Brief summary: The primary objective of this research study is to explore the barriers encountered by specific demographic groups of rectal cancer patients during the engagement in clinical trials, which historically lack diverse representation.

By carefully analyzing data from various demographic perspectives, this study aims to uncover patterns that impact the experiences of future rectal cancer patients. Active involvement in this crucial research is of utmost importance, as it can offer unique insights to enhance the participation and completion rates of rectal cancer patients in clinical study.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of rectal cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No prior treatment for rectal cancer

Exclusion Criteria:

* Pregnant or lactating woman
* Inability to provide written informed consent
* Enrolled in another research study

Primary outcomes:
measure: Number of rectal cancer patients who decide to participate in a clinical study
timeFrame: 3 months
measure: Rate of patients who remain in a rectal cancer clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Alvarez Sarrado E, Giner Segura F, Batista Domenech A, Garcia-Granero Garcia-Fuster A, Frasson M, Rudenko P, Flor Lorente B, Garcia-Granero Ximenez E. Rectal cancer at the peritoneal reflection. Preoperative MRI accuracy and histophatologic correlation. Prospective study. Cir Esp (Engl Ed). 2022 Aug;100(8):488-495. doi: 10.1016/j.cireng.2022.05.019. Epub 2022 May 18.
citation: Bregendahl S, Bondeven P, Gronborg TK, Brown G, Laurberg S, Pedersen BG. Training of radiology specialists in local staging of primary rectal cancer on MRI: a prospective intervention study exploring the impact of various educational elements on the interpretive performance. BMJ Open Qual. 2022 Aug;11(3):e001716. doi: 10.1136/bmjoq-2021-001716.
citation: Qaderi SM, Dickman PW, de Wilt JHW, Verhoeven RHA. Conditional Survival and Cure of Patients With Colon or Rectal Cancer: A Population-Based Study. J Natl Compr Canc Netw. 2020 Sep;18(9):1230-1237. doi: 10.6004/jnccn.2020.7568.