Comprehensive Study on the Quality of Life in Cervical Cancer Patients

NCT03967457 | Unknown DMC

• 1 other identifier: CCQOL
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.

Conditions

Quality of Life; Cervical Cancer; Urodynamics; Rectum Dynamics; Sex Dysfunction; Pelvic Floor Disorders; Ovarian Reserve Function; Survivorship; Disease-free Survival; Overall Survival

Outcome Measures

Primary Outcomes (2)

• Scores from EORTC QLQ-C30

  Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

  Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.

• Scores from EORTC QLQ-CX24

  Scores calculated from EORTC QLQ-CX24

  Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.

Secondary Outcomes (15)

• Concentration of follicle-stimulating hormone

  Change from the baseline of four weeks before major therapy at following-up

• Concentration of estradiol

  Change from the baseline of four weeks before major therapy at following-up

• Concentration of anti-mullerian hormone

  Change from the baseline of four weeks before major therapy at following-up

• Concentration of inhibin B

  Change from the baseline of four weeks before major therapy at following-up

• Bladder capacity at the first void sense

  Change from the baseline of four weeks before major therapy at following-up

Interventions

questionnaires survey DIAGNOSTIC_TEST

Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)

Urodynamic testing DIAGNOSTIC_TEST

Urodynamic testing consists of important urodynamic parameters including: Bladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume

Rectum dynamics testing DIAGNOSTIC_TEST

Rectum dynamics testing consists of important parameters of rectum activities

ovarian reserve function DIAGNOSTIC_TEST

Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. They should be 18 years or older, accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study cente and achieving response after the major therapy.

You may qualify if:

• Primary uterine cervical carcinomas
• Aged 18 or older
• Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center
• Informed consents delivered

You may not qualify if:

• Not accepting any of the four kinds of evaluations for quality of life
• Recurrent patients
• Not achieving response after above major therapy

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples for the testing of ovarian reserve function

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 30, 2019
• Study Start: June 19, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)