Recruiting

HRQOL Assessment

Sponsor:

University of Leeds

Code:

NCT07806266

Conditions

Metastatic Beast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The overall aim of this project is to help improve the Health Related Quality of Life (HRQOL) of metastatic breast cancer (MBC) patients. There is currently an urgent and unmet need for specific tools to aid in the evaluation of HRQOL in MBC and this project aims to address these needs by developing a comprehensive EORTC questionnaire for assessing the HRQOL of this group. The new module will be used in conjunction with EORTC QLQ-C30 and will provide better measurement of the quality of life issues experienced by women with MBC. Interviews will be conducted with patients from several centres across Europe, guiding the development process in a patient centred way.

Conditions

Metastatic Beast Cancer

Study ID

NCT07806266

Start date

May 1, 2020

Status verified date

Sep, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult females aged 18 years or over.
  • Have a diagnosis of MBC (Breast cancer that has spread to another part of the body), including de novo MBC patients. Patients with brain metastases will be included, providing there is no associated major cognitive impairment.
  • Have received (patients under observation) or currently receiving treatment for MBC, including chemotherapy, hormone therapy, targeted agents (anti-HER2, CDK4/6 inhibitors, mTOR/PIK3CA inhibitors, PARP inhibitors, immune therapy), radiotherapy and combinations.
  • Conversant in the language of questionnaire administration.
  • Have the capacity to give informed consent.

Exclusion Criteria:

  • Patients diagnosed with early stage breast cancer.
  • Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation in interviews.
  • Patients previously involved in Phase I.

Study Design

Enrollment

568 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Quality of life of females with metastatic breast cancer [ Time Frame: 1 month ]

Central Contacts and Locations

Locations

Odette Cancer Center - Sunnybrook Health Sciences Center

Recruiting

Toronto, Canada

Contacts

Edward Chow

edward.chow@sunnybrook.caedward.chow@sunnybrook.ca

Jennifer Leigh

416-480-5000jennifer.leigh@sunnybrook.ca

More Information

Sponsor

University of Leeds

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Leeds on 2026-09-08.