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CTRI Number  CTRI/2023/02/049972 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 13/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA)
Other (Specify) [Diet and Spirituality]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To develop a Rehabilitation Model including Physiotherapy, Yoga, Diet and Spirituality for treatment related complications for breast cancer patients.  
Scientific Title of Study   Development of Holistic Rehabilitation Model includes Physiotherapy, Yoga, Diet and Spirituality for the management of treatment related complications among patients with breast cancer. 
Trial Acronym  PhyYogDS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelam Kumari 
Designation  PhD Scholar 
Affiliation  Lovely Professional university, Punjab. 
Address  Registration number:41700179 Faculty of Applied Medical Sciences, Lovely Professional University, Jalandhar

Kapurthala
PUNJAB
144402
India 
Phone  9682120136  
Fax    
Email  khullar.neelam06@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suresh Mani 
Designation  HOD and Professor 
Affiliation  Lovely Professional university, Punjab. 
Address  Faculty of Applied Medical Sciences, Lovely Professional University, Jalandhar

Kapurthala
PUNJAB
144402
India 
Phone    
Fax    
Email  suresh.22315@lpu.co.in  
 
Details of Contact Person
Public Query  
Name  Neelam Kumari 
Designation  PhD Scholar 
Affiliation  Lovely Professional university, Punjab. 
Address  Registration number:41700179 Faculty of Applied Medical Sciences, Lovely Professional University, Jalandhar

Kapurthala
PUNJAB
144402
India 
Phone  9682120136  
Fax    
Email  khullar.neelam06@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Jammu, Jammu and Kashmir. 
 
Primary Sponsor  
Name  Neelam Kumari 
Address  Registration number-41700179, Faculty of Applied Medical Sciences, LPU- Jalandhar. 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Neelam Kumari  Government Medical college and Hospital, Jammu  oncology ward, department of oncology and radiotherapy.
Jammu
JAMMU & KASHMIR 		 09682120136

khullar.neelam06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, Jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diet  1. Participants will be directed to consume a low-fat and high-carbohydrate content diet; 2. must include anti-inflammatory herbs and spices like turmeric, cumin, garlic, ginger, etc. in their diet; 3. participants will be directed for consuming flax seeds, fish oil, fresh and seasonal fruits, vegetables, and whole grains as part of their diet. Total Duration: 8 weeks 
Intervention  Physiotherapy  1.Range of motion exercises of all joints including the ipsilateral shoulder will be advised for 30 minutes daily for 8 weeks; 2. Mobilization of the ipsilateral shoulder for 30 minutes twice weekly for 8 weeks; 3.Combined Lymphedema decongestive therapy including manual lymphatic drainage five days a week for 8 weeks; 4. Progressive resistance strengthening exercises will be advised for 40 minutes twice a week for 8 weeks; 5.Stretching of the pectoralis major, Deep breathing, and Relaxation exercises 30 minutes daily for 8 weeks. Total duration for each intervention: 8 weeks 
Comparator Agent  Routine Care  The Control group will not receive any specific treatment and will receive routine care. total duration: 8 weeks 
Intervention  spirituality  1. Participants will be directed for practicing meditation and relaxation; 2. participants will be advised to coping mechanisms like acceptance, positive reinterpretation, avoidance and distraction, yoga session, mental disengagement, and visual imagery; 3. participants will also be directed to daily prayers according to their religious beliefs. Total Duration: 8 weeks 
Intervention  Yoga  1.Participants will perform Suksham kriya as warm up for yoga session for 20 minutes, 2.yogic asanas like balasana, tadasana, vajrasana, Pawanmukt asana, chakki chalan asana etc, for 30 minutes, 3.pranayama for 10 minutes 4.yogic meditation with mudras like padamasana, sukhasana, sidhasana while chanting Om or Ajjapa Jaap Total duration: 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  patients diagnosed with breast cancer stage I-III.
Patients diagnosed within the last 6 months.
Patients undergoing treatment (chemotherapy, radiotherapy, surgery) 
 
ExclusionCriteria 
Details  Patients with advanced breast cancer stage IV.
Any previous or concurrent malignancy.
Patients diagnosed with any psychological condition like obsessive-compulsive disorder or schizophrenia.
Patients with any major comorbidity like neurological or cardiovascular disorders.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. quality of life will be assessed with EORTC QLQ-C30
2. Disease-related functional assessment will be measured with FACT-B
3. Spiritual well-being with FACIT-sp
4. Anxiety and depression will be assessed with HADS Scale
5. Sleep quality will be assessed with the Pittsburg sleep inventory
6. physical assessment with Range of motion and Manual muscle testing
7. Functional independence will be assessed with a Functional independence measure
 		 1. EORTC QLQ-C30 at baseline and week 8
2. FACT-B at baseline and 8 weeks
3. FACIT-sp at baseline and week 8
4. HADS Scale at baseline and week 8
5. Pittsburg sleep inventory(PSQI) at baseline and week 8.
6. Range of motion and Manual muscle testing at baseline and week 8.
7. Functional independence measure(FIM) at baseline and week 8.
 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

PROTOCOL TITLE: DEVELOPMENT OF HOLISTIC REHABILITATION MODEL INCLUDES PHYSIOTHERAPY, YOGA, DIET AND SPIRITUALITY FOR THE MANAGEMENT OF TREATMENT RELATED COMPLICATION AMONG PATIENTS WITH BREAST CANCER.

 

 

STUDY BACKGROUND AND NEED: 

 

Patients receiving treatment for breast cancer face various adverse effects. Despite the advances in oncology that increase the survival rate of cancer patients, the QOL remains on the negative side. The present-day scenario of cancer treatment focuses mainly on the disease and very little attention is given to the management of side effects. Therefore, in order to improve all domains of quality of life and survivorship of breast cancer patients, there is a strong need to prepare a model of rehabilitation that includes components to address all treatment-related complications. 


The purpose of this study is to assess whether a holistic rehabilitation model including physiotherapy, yoga, diet, and spirituality components can help in managing and minimizing breast cancer treatment-related complications in comparison with the standard or usual care. This study is aimed at the development and assessment of a holistic rehabilitation model that will focus on the management of all side effects simultaneously along with conventional cancer treatment. The trial will also assess whether the components of this model will help to reduce, delay, prevent, or improve the severe side effects which may finally result in the improvement of QOL. The result of this study may help in the inclusion and further development of improved holistic approaches for the management of treatment-related side effects. Eventually, this may lead to the development of similar management approaches for other types of cancer


ETHICAL APPROVAL 

 

 The institutional ethics committee government medical college Jammu has approved the study for trial.

 STUDY DESIGN

This will be a controlled randomized parallel-group trial 

 SETTING

The study will be carried out in the oncology department, government medical college, and hospital, Jammu and Kashmir The Study will be conducted with permission from higher concerned authorities.

TARGET POPULATION

All In-department patients receiving treatment for breast cancer for it will be screened for inclusion and exclusion criteria for the study. Those fulfilling the inclusion criteria of the study will become part of it.

 INCLUSION CRITERIA

Patients of breast cancer stage I-III.

 Patients undergoing multimodal treatment for breast cancer (surgery, radiotherapy, chemotherapy).

 Age from 18 years to 65 years



 EXCLUSION CRITERIA

 Includes advanced breast cancer stage IV.

Any diagnosed psychological conditions like obsessive-compulsive disorder or schizophrenia.

Any major comorbidities like neurological or cardiovascular disorders.

Any previous or concurrent malignancy.

 

SAMPLE SIZE

After reviewing potential participants, a total of 70 participants will be selected as a sample with 35 patients in each group (interventional and control).

RANDOMIZATION 

computer-based randomization 

PROCEDURE 

 Formal consent will be obtained from the concerned authority of the government medical college in Jammu and its oncology ward. Formal consent will also be obtained from individual patients fulfilling the inclusion criteria of the study. The selected patients will be divided into two groups, an interventional group, and a control group. Patients will be assigned to either group based on computer-based randomization. All patients will be assessed at baseline (w0), and eighth week (W8). The interventional group will receive treatment according to the PhyYogDS model for eight weeks while the control group will not be given any special care related to physical activity and will be advised to continue their routine as usual for eight weeks of follow-up (Leclerc et al., 2017).

 Description of protocol to be followed    

Physiotherapy: Range of motion exercises of all joints including the ipsilateral shoulder will be advised for 30 minutes daily for 8 weeks; Mobilization of the ipsilateral shoulder for 30 minutes twice weekly for 8 weeks; Combined Lymphedema decongestive therapy including manual lymphatic drainage five days a week for 8 weeks; Progressive resistance strengthening exercises will be advised for 40 minutes twice a week for 8 weeks; Stretching of pectoralis major, Deep breathing, and Relaxation exercises 30 minutes daily for 8 weeks.

 Yoga: Participants will perform Suksham kriya as warm up for yoga session for 20 minutes, yogic asanas like balasana, tadasana, vajrasana, Pawanmukt asana, chakki chalan asana etc, for 30 minutes, pranayama for 10 minutes followed by yogic meditation with mudras like padamasana, sukhasana, sidhasana while chanting Om or Ajjapa Jaap

 Diet: Participants will be directed to consume a low-fat and high carbohydrate content diet; must include anti-inflammatory herbs and spices like turmeric, cumin, garlic, ginger, etc. in their diet; participants will be advised for consuming flax seeds, fish oil, fresh and seasonal fruits, vegetables and whole grains as part of their diet.

Spirituality: Participants will be directed for practicing meditation and relaxation; participants will be advised to coping mechanisms like acceptance, positive reinterpretation, avoidance and distraction, yoga session, mental disengagement, and visual imagery; participants will also be advised to daily prayers according to their religious beliefs.

Control group: The Control group will not receive any specific treatment and will receive routine care.

OUTCOME MEASURES

The following outcome measure will be used in the present study for standardized assessment-

Table: Variables and tools of measurement

 

Tools

Variables

1.     Functional assessment of cancer therapy (FACT-B) (Brady et al., 1997)

Physical wellbeing, social/ family wellbeing, emotional wellbeing, functional wellbeing.

2.     Functional assessment of cancer therapy – spirituality (FACIT-sp) (petermen et al., 2002)

Spiritual wellbeing. (sense of meaning/peace).

3.      Hospital anxiety and depression scale (HADS) (Bjelland et al., 2002)

Anxiety and depression.

4.     Pittsburgh sleep quality inventory (PSQI) (Buysse et al., 1989; Beck et al., 2004)

Sleep quality, sleep disturbance, sleep latency, sleep duration, sleep efficiency, use of medication for sleep, day time dysfunction

5.     Functional independence measure (FIM) (Cole et al., 2000; Linacre, 1994)

For measuring degree of disability.

6.     Range of motion (ROM)

 Joint range of motion.

7.     Manual muscle testing (MMT)

For measuring muscle power.

8.  European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (Aaronson N et al, 1993).

Health Status, Functional Role, Emotional State and Physical, Cognitive and social functions.

 

  STATISTICAL ANALYSIS

After completing the data collection, the data will be analysed using descriptive statistics in SPSS to find statistically significant results which will be displayed by using tables and figures. The result of continuous variables will be presented by calculating mean and standard deviation and categorical variables by frequencies. The comparison between groups of continuous variables will be carried out by t-test and for categorical variables by x2. Within each group paired t-tests will be used to compare measures at W0, and W8. Results will be considered significant at a 5% level (p<0.05) (Leclerc et al., 2017).

RESULT:

After the completion, the data will be analysed and interpreted and a conclusion will be drawn.



REFERENCES:

1.     Polyak, K. (2011). Heterogeneity in Breast Cancer. Journal of Clinical Investigation, 121(10), 3786- 88.

2.     Coates, A., Abraham, S., Kaye, S. B., Soucerbutts, T., Frewin, C., Fox, R. M., & Tattrstall, M. H. N. (1983). On the reclining end- Patients perception of the side effects of Cancer Chemotherapy. European Journal of Cancer, 19(2),  203-8.

3.     Byar, K. L., Bengr, A. M., Bakken, S. L., & Catel, M. A. (2006). Impact of Adjuvant Breast Cancer Chemotherapy on Fatigue, other symptoms and QoL. Oncology Nursing Forum, Pittsburg, 33(1), 218-26.

4.     Schwartz, A. L., Mori, M., Cao, R., Nail, M. L., & King, M. L.(2003). Exercise reduces daily fatigue in women with breast cancer receiving chemotherapy. Journal of American college of sports medicine. 2001; 33.

5. Dangi, A. A., Aurangabadkar, S., & Deo, M. V. (2018). Effect of a structured yoga program on fatigue, depression, cardiorespiratory fitness and quality of life in a post-menopausal breast cancer survivor. Int j yoga,11(3), 255-57.

6.  Rock, C. L., & Wahnefrid, W. D. (2002). Nutrition and survival after the diagnosis of breast cancer: A review of the evidence. J Clin Oncol, 20 (15), 3302-16.

7.    Schulz, E., Holt, C. L., Caplan, L., Blake, V., Southward, P., Buckner, A., & Lawrence, H. (2008). Role of spirituality in cancer coping among African American: A Qualitative examination. J Cancer Survive,  2(2), 104-15. 

8.    Marciniak, C. M., Sliwa, J. A., Spill, G., Heinemann, A. W., & Seimik, P. E. (1996). Functional outcome following rehabilitation of cancer patient. Arch Phys Med Rehabil,  77, 54-7.

 


 
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