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Effect of Mind Body Medicine Program in Young Female Breast Cancer patients on sleep quality, quality of life and physiological and biochemical parameters

Effectiveness of “Healthy Breast-Mind Body Medicine Program ?(HB-MBMP) in addition to Standard Care in Young Female Breast Cancer patients on Sleep Quality, Circadian rhythm (HPA axis Regulation), QoL in a Tertiary Care Hospital in Rishikesh, Uttarakhand: An Open Label Double-arm Randomized Control Trial - HB-MBMP Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076635
Enrollment
108
Registered
2024-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: HP-MBMP (Healthy Breast-Mind Body Medicine Program) & Standard care: “Healthy Breast MBM Program ? (60 minutes)per day X 6 Months A. Annamaya Kosha 1. Diet counselling : Positive prom

Sponsors

CCRYN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Young women aged 15-39 years’ patients diagnosed with histologically confirmed breast carcinoma with newly diagnosed cases with I – III stages. Patients undergoing active treatment for breast carcinoma, including surgery, chemotherapy, radiation therapy, hormone therapy, or a combination of these treatments. Patients with a ECOG score of 60 or above, indicating a reasonable ability to perform daily activities Patients who can provide informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with severe cognitive impairments or mental health conditions that may hinder their ability to participate in yoga sessions or complete study assessments Patients with physical disabilities or musculoskeletal conditions that may prevent them from safely engaging in yoga practices Patients with severe uncontrolled comorbidities (e.g., heart failure, chronic obstructive pulmonary disease) that may limit their ability to participate in yoga safely Patients currently engaged in other mind-body practices or alternative therapies that may confound the study results Patients with a history of prior yoga intervention for breast carcinoma within the past six months Pregnant patients, as yoga practices may need to be modified during pregnancy, and hormonal changes during pregnancy can impact study outcomes Patients not having access to smartphones and Internet connectivity

Design outcomes

Primary

MeasureTime frame
Sleep Quality (PSQI)Timepoint: Day 0, Day 30, 3 month, 6 month/termination of trial

Secondary

MeasureTime frame
Salivary CortisolTimepoint: Day 0, 6 month/termination of trial;Salivary DHEATimepoint: Day 0, 6 month/termination of trial;ACTHTimepoint: Day 0, 6 month/termination of trial;CRHTimepoint: Day 0, 6 month/termination of trial;HRVTimepoint: Day 0, 6 month/termination of trial;Level of LymphedemaTimepoint: Day 0, 6 month/termination of trial;Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0)Timepoint: Day 0, Day 30, 3 month, 6 month/termination of trial;Anxiety, Stress and DepressionTimepoint: Day 0, Day 30, 3 month, 6 month/termination of trial;Positive and Negative Affect ScheduleTimepoint: Day 0, Day 30, 3 month, 6 month/termination of trial

Countries

India

Contacts

Public ContactDr Vartika Saxena

AIIMS, Rishikesh

vartika.cfm@aiimsrishikesh.edu.in8475000294

Outcome results

None listed

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