Study setting {9}
Patients will be recruited for the study primarily at Thumbay Physical Therapy and Rehabilitation Hospital and Gulf Medical University, Ajman, UAE. Other hospitals and organizations catering breast cancer support to the survivors would also be explored in all seven emirates of UAE. The proposed list of hospital for approval are as follows:
- Burjeel Hospitals, Dubai
- American Hospital, Dubai
- Emirates Cancer Society, Ajman
- Al Tawam Hospital, Abu Dhabi
- Czech Rehabilitation Hospital, Dubai
- Burjeel Royal Hospital, Abu Dhabi
- VPS Healthcare Cancer Center, Abu Dhabi
- Al Mafrah hospital, Abu Dhabi
- Sharjah University Hospital, Sharjah
- Gulf International Cancer Centre, Abu Dhabi
- Zuleikha Hospital, Sharjah
- Mediclinic City Hospital, Dubai
- Cleveland clinic, Abu Dhabi
- Friends of Cancer, Sharjah
Eligibility criteria {10}
During the screening and study period, the investigators will assess the patients for eligibility and collect demographic and medical history. The inclusion criteria are as follows:
Inclusion criteria
a) Breast cancer survivors who have undergone- chemotherapy, mastectomy, and cleared for post-surgical physical rehabilitation.
b) Age group -18 years to 65 years
c) Female participants (breast cancer survivors)
d) Diagnosed with stage I–stage IIIa breast cancer. (As other stages of cancer include metastasis)
Exclusion criteria
a) Patients diagnosed with prior cardiorespiratory disorders, cognitive dysfunction, and other health problems that would prevent safe participation.
b) Active breast cancer patients.
c) Participants who engaged in physical activity like the intervention group in any form.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Not applicable, the study does not use any biological specimens or provisions for additional data.
Explanation for the choice of comparators {6b}
The comparators used in the study were chosen based on the study design, research question and to match the objectives of the study.
Interventions{11a}
The intervention group will receive a structured exercise adapted from the BReast cancer and EXercise (BREX) program which has shown significant improvement in Quality of Life and Physical Fitness among breast cancer survivors (15). The exercise program will continue for 2 months, and a follow-up will be done after 3 months. The exercise program has been detailed in Table 1. Exercise would be prescribed and supervised by the physical therapist (FR and WA). The control group will continue with their routine life and will receive standard care given by the hospital.
Table 1. Description of the proposed Physical Rehabilitation Program among breast cancer survivors
Components of Physical Rehabilitation Program
Supervised – 2 times a week.
Individually Tailored Program- 3 times a week
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Frequency (5 times a week for 2 months)
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Supervised Training: Two types over alternate weeks: 1) 60-minute step aerobics class 2) 60 minutes circuit training classEach class will include warm-up and cool-down periods both lasting 10-15 min. The maximum target rate of perceived exertion (RPE) would be set at 14-16 on a 20-point Borg scale, a level of exercise that feels “somewhat hard” or “hard” and coincides with about 86-92% of maximal heart rate, 76-85% of maximal VO 2 and 5-7 metabolic equivalents (METs) ideal for improving the related domains of QoL and Cardiovascular endurance (16). During the first 3 weeks, the participants would exercise at a lower level of RPE (approximately 11-13), to adapt to the training.
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Twice a week
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Individually tailored home program: The type of home training would mainly consist of endurance training such as walking, Nordic walking, or aerobic training, but it would also include jumps and leaps like step aerobics (96 jumps and leaps per home training session) to promote bone health (15). Warm-up and cool-down exercises, such as marching or climbing upstairs would be recommended before and after the home training session. Home training would be aimed so that the total training would comprise a minimum of five training sessions per week.
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Three times a week.
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Strategy for Treatment modification and adherence {11b}{11c}
Participants will be removed if there is a change in the medical condition, adverse effects noted or if they choose to drop out. As the intervention is individually tailored the required modification will be made depending on the patient’s physical ability to adapt to the given exercise protocol. The home program would be randomly and frequently monitored over audio or video phone calls along with a daily logbook which would be maintained and entered by the therapist after discussion with the patient.
Concomitant Care {11d}
No participant will be restricted from receiving external care, if any participant in the intervention or control group is matching with the exercise program of the intervention group, the data would be excluded for statistical analysis.
Outcomes {12}
- Cardiorespiratory Health
- Quality of Life
Participant timeline {13}
The schedule and plan of the study is illustrated in Figure 1.
Sample size {14}
The sample size was calculated using the formula for comparison of two means. The outcome variable used was Vo2 max (Cardiorespiratory endurance variable) which was taken from a previous study (13). The details on sample size calculation are as follows for 95% Confidence Interval and power set at 80%.
Considering, 20 percent drop out and lost to follow up, the total sample size was 72 (36 each group).
Enrollment, Intervention and Recruitment plan {15}
The participant in the study would be recruited under the purposive sampling method. In addition, hospitals from all emirates would be contacted for sharing the contacts of potential participants from the medical records to meet the target sample size. The study follows the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) guidelines, Figure 2 (14)The recruitment of participants will been illustrated using the CONSORT flow diagram (15).
Allocation of Participants and Intervention: Randomization and Blinding
{16a} {16b} {16c} {17a} {17b}
Participant would be allocated to two groups, randomized into equal allocation ratio (1:1) using simple randomization method through sealed envelope, with 36 randomized to intervention and 36 to control. Randomization for subject allocation would be double blinded and facilitated through a person not involved in the study. Allocation of intervention will not be blinded and conducted by two researchers in the study FR and WA (physical therapists).
Data collection {18a}
Data would be collected using the data collection sheet which will focus on the demographics and primary outcome variables using reliable and valid tools. The Cardiorespiratory health will be evaluated by analysis of the submaximal VO2, peak exercise minute ventilation, and direct maximal voluntary ventilation. The 2-km walk test (UKK walk test, Tampere, Finland) would be done along to calculate the submaximal VO2 max and spirometry will be done to record the ventilation values. (16,17,18). The QoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) questionnaire (EORTC QLQ-C30) (version 3) (19).
Follow-up {18b}
All participants in the intervention group would be followed-up after three months of training sessions. The demographics and primary outcome would be reassessed to analyse the effects on baseline, at the end of intervention and follow up. Any adverse effects at the time of follow-up would also be recorded.
Data Management: Storage and Confidentiality: {19} {27}
The raw data would be systematically synthesized into an excel sheet and stored in the institutional data repository system for further analysis. The data would be managed both in soft and hard copies. Any personal information of the participants relating to direct identity would not be used for any purpose, and data confidentiality would be ensured by the investigators.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Not Applicable. The study does not include collection, evaluation, storage of laboratory data through biological specimens for future use.
Data Analysis {20a} {20b} {20c} {21b}
The data would be analysis using the SPSS software package version 29. The descriptive and inferential statistics would be done to test the desired hypothesis. Paired and Unpaired t test would be conducted to analyses the changes in the primary outcomes for within and between group analysis. Repeated measures ANOVA would be done for determining the changes at baseline, end of intervention and follow-up for the intervention group. If the trial needs to be terminated due to any reasons, interim analysis would be done for average the period of the trial for all participants and the trial would be terminated on decision from the senior researchers (AH and PK). No adjusted analysis is planned for this research. Missing data would be analysis through intention-to-treat analysis.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
The protocol would be published and dataset would be provided in the repository for public access after completion of the study.
Oversight and Data Monitoring {5d} {21a}
The data would be monitored monthly by the institutional research committee comprised of senior researchers from the study (AH and PK) along with the head of the department, and head of the institution. Any administrative, organizational support would be provided by the College of Health Sciences, Gulf Medical University, United Arab Emirates.
Adverse event reporting and Post- Trial Care {22} {30}
If any adverse effects would be noted and immediately reported by the supervising investigators with record maintenance. If required, participants would be given appropriate treatment and post-trial against any harms at the Thumbay Hospital, UAE.
Frequency and plans for auditing trial conduct {23}
Not Applicable
Protocol amendment reporting {25}
Any essential changes in the protocol would be intimated to the ethical committee and consequent changes would be made in the ethical approval letter along with participant information sheet.
Dissemination plans {31a}
The findings of the study would be published in the quality, peer reviewed, high impact factor indexed journals. Also, findings would be presented at the national and international conferences related to breast cancer.