Finding the Minimal change in value of Six Minute Walk Distance in patients with Breast Cancer.

Not yet recruiting

Conditions: Malignant neoplasm of breast of unspecified site,

Registration Number: CTRI/2022/02/040699

Lead Sponsor: Manipal University

Brief Summary: The study protocol will be submitted to the Scientific and Institutional Ethics Committee, KMC Mangalore and upon approval, patients diagnosed with Breast Cancer and scheduled for Chemotherapy would be screened for inclusion and exclusion criteria. Patients fulfilling the inclusion criteria would be explained about the study and the willing participants would be asked to sign a written consent. Demographic data of the participants will be collected and written by the investigator.

Participants would undergo 6MWT at baseline (pretreatment) and after 16 weeks. The quality of life over the past week will be assessed by the EORTC QLQ-C30 at baseline and after 16 weeks and will be graded by the Likert scale.

Based on the anchor (Using the physical domain changes in questionnaire) and distribution (standard error, effect size of 6MWD based methods, statistically using (Boot strap) the MCID of 6MWD in patients with Breast Cancer will be calculated.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Patients with Breast Cancer stage IIâ€“III scheduled for curative intent chemotherapy treatment.
2.ECOG (Eastern Cooperative Oncology Group) performance status <2 3.Age 18years of age.

Exclusion Criteria

1.Any musculoskeletal problems (e.g. knee pain, ankle pain) 2.Comorbidities limiting the 6MWT field testing (eg: cardiac arrhythmias, acute myocardial infarction, angina pectoris, patients with LVEF < 40 %).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To estimate the minimally clinical important difference (MCID) of six minute walk distance (6MWD) in patients with Breast Cancer using Anchor and Distribution based methods.	Baseline and 16 weeks.
2)To evaluate the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline (pretreatment) and after 16 weeks and to correlate physical domain of the questionnaire with Six minute walk distance (6MWD).	Baseline and 16 weeks.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Kasturba Medical College
🇮🇳
Kannada, KARNATAKA, India
Kasturba Medical College
🇮🇳Kannada, KARNATAKA, India
ravindra reddy
Principal investigator
9566726536
raviramu30@gmail.com