NCT05915637

Brief Summary

To investigate and analyze the status of preoperative frailty and its influencing factors in elderly patients with colorectal cancer using FRALL scale and other related scales, and to explore the correlation between preoperative frailty and early prognosis in elderly patients with colorectal cancer, so as to attract the attention of medical staff to preoperative frailty in this population and provide a preliminary research basis for the study of frailty intervention in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

June 1, 2023

Last Update Submit

June 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fatigue Assessment

    Status of frailty will be assessed by FRALL Scale

    7 days

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer

You may qualify if:

  • age ≥60 years old;
  • Colorectal cancer was diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 edition) and planned to undergo elective laparoscopic radical resection of colorectal cancer;
  • able to complete physical assessment without communication barriers;
  • voluntarily participated in this study after informed consent.

You may not qualify if:

  • taking antidepressants, levodopa, donepezil hydrochloride and other drugs;
  • patients with preoperative colorectal cancer surgery or neoadjuvant therapy;
  • patients with TNM stage Ⅳ;
  • complicated with other malignant tumors except primary skin cancer or melanoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongmei Zhang

Zunyi, Guizhou, 563000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 23, 2023

Study Start

September 1, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations