what is the role of mindfulness in breast cancer survivors.

Not yet recruiting

• Conditions: Malignant neoplasm of overlappingsites of breast,

• Registration Number: CTRI/2023/07/055461
• Lead Sponsor: ICMR

Brief Summary

Breast cancer is one of the most common cancer in our country. The survivors often suffer from pain, fatigue, stress, anxiety, inability to cope up with the disease etc. There is paucity of literature regarding benefits of mindfulness based intervention: MBI  in this subgroup. MBI is an evidence based intervention with established role in various chronic diseases like diabetes, polyneuropathies, chronic pain conditions etc. It emphasises participants to pay attention to the situation in a compassionate and non judgemental manner. Though there have been studies on breast cancer survivors in Western world, data is lacking in India. hence, this study aims to determine to feasibility and benefits of MBI on psychological, behavioural and biochemical parameters of breast cancer survivors.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-08
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Breast cancer survivors stage 0 to IIIa who would have completed cancer treatment within the past 3 years (except for tamoxifen/aromatase inhibitors).
• They should be at least 2 months postsurgery or adjuvant therapy or radiation, whichever occurred later.

Exclusion Criteria

• –Exclusion criteria would be patients on active therapy, inflammatory breast cancer, anemia, diabetes, chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease, conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse, current yoga practice (within the last 6 months), and/or previous yoga practice for more than 3 months.
• Women reporting 5 hours or more of vigorous physical activity per week will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
perceived stress and depression: PPS (Perceived Stress Scale) and	baseline, 6 weeks, 3 months
HADS	baseline, 6 weeks, 3 months

Secondary Outcome Measures

Name	Time	Method
Effect on inflammatory markers: IL-6, interleukin-1 beta , C reactive protein and human TNF	Effect on serum cortisol levels.1

Trial Locations

Locations (1)

AIIMS,Patna; 🇮🇳 Patna, BIHAR, India

AIIMS,Patna

🇮🇳Patna, BIHAR, India

Chandni Sinha

Principal investigator

7250333148

chandni.doc@gmail.com