Skip to content

To study compliance in Hormone Receptor Positive Early (non-metastatic) Breast Cancer patients receiving hormonal therapy.

â??Evaluation of Compliance in Hormone Receptor Positive Early (non-metastatic) Breast Cancer Patients receiving hormonal therapy from a Tertiary Care Cancer Centerâ??.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030575
Enrollment
1500
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D058- Other specified type of carcinomain situ of breast

Interventions

Intervention1: Counselling: No treatment is planned. Intervention is only in the form of "counselling" only in the second (prospective) phase, wherein the counselling will be carried out 4 times at 6

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with histologically confirmed non-metastatic breast cancer 2) Hormone receptor (HR) positive (defined as at-least 1% cells positive for either ER or PR or both) and 3) Who will be attending the breast OPDâ??s of any discipline during the study period irrespective of their registration date to Tata Memorial Centre. 4) Patients on treatment with endocrine therapy who had completed at least 6 months of treatment (this corresponds to one prescription fill).

Exclusion criteria

Exclusion criteria: 1) Non-Indianpatients 2) Metastatic disease 3) Not received cancer-directed surgery 4) Those patients who have not completed at-least 6 months of endocrine therapy 5) Had experienced recurrence prior to the 2-year follow-up survey (For only prospective cohort)

Design outcomes

Primary

MeasureTime frame
To evaluate the compliance to oral endocrine therapy in non-metastatic breast cancer patients on adjuvant endocrine therapy. Timepoint: 1) Retrospective Cohort Patients in the retrospective group will be assessed only once via the direct questionnaire and/or telephonic contact at a single time point (after completion of minimum 6 months of endocrine therapy). 2) Prospective cohort Patients in the prospective cohort will be assessed at 5 different time points, i.e., initially at the time of enrollment into the study and subsequently at every 6 months for a total period of 2 years

Secondary

MeasureTime frame
To assess factors associated with non-adherence to treatment.Timepoint: 1) Retrospective Cohort Patients in the retrospective group will be assessed only once via the direct questionnaire and/or telephonic contact at a single time point(after completion of minimum 6 months of endocrine therapy). 2) Prospective cohort Patients in the prospective cohort will be assessed at 5 different time points, i.e., initially at the time of enrollment into the study and subsequently at every 6 months for a total period of 2 years

Countries

India

Contacts

Public ContactDr Jyoti Bajpai

Tata Memorial Center

dr_jyotibajpai@yahoo.co.in022-24177287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026