Development of an algorithm for measuring QOL indicators, mainly fatigue during chemotherapy for gynecological cancer patients.

Development of an algorithm for measuring QOL indicators, mainly fatigue during chemotherapy for gynecological cancer patients. - JGOG9007

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054460

Enrollment

310

Registered

2024-06-30

Start date

2024-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gynecological malignancy

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1) Patients with gynecological cancer (2) Patients who have undergone surgery for primary gynecological cancer and are expected to receive chemotherapy. (3) Patients who are expected to receive chemotherapy for recurrent gynecological cancer and who have not received non-surgical treatment for the disease within the previous six months. (4) 18 years of age or older (5) Patients who have a smartphone and are able to use mobile applications. (6) Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with primary disease who have already undergone surgery, chemotherapy or radiation for the disease (2) Patients with recurrent disease who have received surgery, chemotherapy, or radiation for the disease within the previous 6 months (3) Patients who have received treatment for other malignancies within the previous 6 months (4) Patients with metastatic cancer (5) Patients who are unable to use mobile applications even with assistance (6) Patients who are considered ineligible by their physician, whose consent has not been obtained, and who have offered to withdraw their consent

Design outcomes

Primary

Measure	Time frame
The percentage of agreement between changes in HRV and adverse events during chemotherapy in patients with primary gynecological cancer	—

Secondary

Measure	Time frame
Development, reliability and validation of Daily PRO The percentage of agreement between changes in HRV and adverse events during chemotherapy in patients with recurrent gynecological cancer The percentage of correct responses of QOL prediction algorithms developed using time-series data of individual HRV Reliability and validity of a novel scale to assess fatigue, depression and general health from HRV and lifelogs Qualitative study of the patient burden of reporting daily PRO and recording the lifelog once a day	—

Measure

Time frame

Development, reliability and validation of Daily PRO The percentage of agreement between changes in HRV and adverse events during chemotherapy in patients with recurrent gynecological cancer The percentage of correct responses of QOL prediction algorithms developed using time-series data of individual HRV Reliability and validity of a novel scale to assess fatigue, depression and general health from HRV and lifelogs Qualitative study of the patient burden of reporting daily PRO and recording the lifelog once a day

—

Countries

Japan

Contacts

Public ContactNozomi Higashiyama

Kyoto University Graduate School of Medicine Department of gynecology and obstetrics

nozomi28@kuhp.kyoto-u.ac.jp0757513269

Outcome results