To develop a Rehabilitation Model including Physiotherapy, Yoga, Diet and Spirituality for treatment related complications for breast cancer patients.
- Conditions
- Malignant neoplasm of overlappingsites of breast,
- Registration Number
- CTRI/2023/02/049972
- Lead Sponsor
- Neelam Kumari
- 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 *x*2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 70
- patients diagnosed with breast cancer stage I-III.
- Patients diagnosed within the last 6 months.
- Patients undergoing treatment (chemotherapy, radiotherapy, surgery).
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 4. Anxiety and depression will be assessed with HADS Scale 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. 5. Sleep quality will be assessed with the Pittsburg sleep inventory 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. 1. quality of life will be assessed with EORTC QLQ-C30 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. 2. Disease-related functional assessment will be measured with FACT-B 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. 3. Spiritual well-being with FACIT-sp 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. 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. 6. physical assessment with Range of motion and Manual muscle testing 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 Measures
Name Time Method Not Applicable Not Applicable
Trial Locations
- Locations (1)
Government Medical college and Hospital, Jammu
🇮🇳JAMMU, & KASHMIR, India
Government Medical college and Hospital, Jammu🇮🇳JAMMU, & KASHMIR, IndiaNeelam KumariPrincipal investigator09682120136khullar.neelam06@gmail.com