Human Universal Energy Improved Health-related Quality of Life Outcomes 1 Month After External Beam Radiotherapy for Early-stage Breast Cancer

Abstract

Background

The demand for the use of human universal energy (HUE) as a form of complementary alternative medicine (CAM) for cancer treatment is increasing, but scientific evidence of its efficacy is lacking.

Aims

The aims of this first randomized study of external beam radiotherapy (EBRT) + HUE versus EBRT + sham HUE in subjects with early breast cancer were to (1) document the changes in health related quality of life (HRQoL) during EBRT and immediately 1 mo after completion of radiation treatment within each subject group and to (2) compare the differences in HRQoL between the 2 groups of subjects.

Method

Eligible subjects were randomized to either HUE (n = 16) or sham-HUE (n = 16). HRQoL measurements were taken in each patient group before starting treatment, during week 3 of EBRT, immediately after completing treatment, as well as 1 mo after EBRT. These results were evaluated using the validated functional assessment of cancer therapy-breast cancer (FACT-B) HRQoL instrument consisting of the FACT-G and breast cancer specific subscales and trial outcome index (TOI) summary scores. Changes in the scores relevant to both groups were compared using a Mann-Whitney U test. The effect of the HUE treatment was quantified by analysis of covariance (ANCOVA) models. All statistical analysis was done at a 95% confidence interval and the differences were considered significant if P ≤ .05.

Results

The tests associated with FACT-G, social wellbeing, and emotional well-being scores returned insignificant P value > .05. The test associated with physical well-being and FWB returned significant P value ≤ .05, but the (adjusted) quantified influence of the HUE treatment on these scores was less than the clinically significant threshold of 5 points, and the FWB clinically significant threshold of greater than 2.9 points. The test associated with FACT-B, breast cancer specific (BCS), and TOI scores returned significant or close to significant P value, α ≤ .05, and the (adjusted) quantified influence of HUE treatment on these scores is more than the accepted thresholds (5 points for BCS and 10 points for FACT-B and TOI) for clinical difference.

Conclusion

Although some results, such as P values for Mann-Whitney U tests and coefficients of HUE treatment in initial ANCOVA models showed promising and positive effects of HUE treatment on the subject, further research with a larger sample size is necessary to confidently conclude whether HUE treatment has significant positive influence on subject HRQoL.

Introduction

Background and Objectives

Conventional medical (CM) therapy alone is unsatisfactory for the treatment of many chronic degenerative diseases, including cancer.^1,2 Consequently, complementary alternative medical (CAM) therapies, such as acupuncture, Chinese medicinal herbs, chiropractic, osteopathy, homeopathy, and energy medicine have been increasingly used either alone or combined with CM therapy, particularly in the United States and Australia. For example, a survey conducted by the NPS MedicineWise in 2008 revealed that 65% of Australians had used 1 or more forms of CAM in the past 12 months.³ It has also been estimated that between 9% and 91% of patients diagnosed with cancer in the United States have used some form of CAM after diagnosis.⁴

Demand has been particularly high in the area of energy medicine (or energy healing), which includes techniques such as qigong, reiki, therapeutic touch, and human universal energy (HUE). Several research groups are conducting randomized clinical trials with the aim of providing scientific data for the use of energy healing.⁵

The HUE method of energy medicine was founded by the late Master Dang Minh Luong under the organisation name of Mankind Enlightenment Love (MEL). His wife, Professor Dr Theresa Thu Thuy Nguyen, then continued the lineage and further developed the HUE method. She is currently the chancellor and chairperson of the Open International University of Complementary Medicines and the president of the Academy of Human Universal Energy and Spirituality (HUESA). HUE method depends on restoring the energy balance that is disrupted as a result of sickness and disease. The hypothesis is that by following these methods and restoring this balance, it will enable the body to heal itself and ensure that health is maintained. To achieve this balance following the HUE method, it is important that all 3 components are met. In order of importance, these components include (1) activation of major nerve points (also referred to as chakras or energy centres), (2) simple breathing exercises and meditation, and (3) energy transfer. It is believed that the activation of major nerve points is the critical step to achieve success with the HUE technique.

The broad aim of the study was to obtain scientific evidence for the efficacy of HUE, and if found beneficial, to provide recommendations for its integration into the conventional medical therapy of cancer. The specific aims of the study were initially to determine changes in health-related quality of life (HRQoL) during treatment and one month after external beam radiotherapy (EBRT) for early stage breast cancer. Subjects were randomized to have the HUE intervention (experimental group) or the sham HUE intervention (control group).

Methods and Materials

A total number of 32 women with early stage (T1 and T2) breast cancer who were referred for EBRT at the Royal Adelaide Hospital (Adelaide, Australia) were recruited for this trial. Patient recruitment was based on the following eligibility criteria: (1) female ≥ 30 years of age with (2) early stage (T1-T2) disease with pathologically negative nodal involvement treated with breast conserving surgery and (3) histologically confirmed infiltrating duct +/- ductal carcinoma in situ and clear microscopic margins of excision, (4) suitable for EBRT including (5) an Eastern Cooperative Group (ECOG) performance status of 0 to 2, and (6) ability to give signed informed consent. The exclusion criteria were as follows: (1) evidence of metastatic disease and (2) to be receiving concurrent chemotherapy. A 2-armed single-blinded randomised design was used. Eligible subjects were randomized by the clinical trials data manager at the Royal Adelaide Hospital Cancer Center, using tables generated by a computer software program called GraphPad to either EBRT + all 3 constituent parts of the HUE technique (experimental group) or EBRT + the sham HUE technique, which excludes the critical first step of the HUE technique (control group). The validated functional assessment of cancer therapy-breast cancer (FACT-B) HRQoL instrument was used to measure HRQoL in each subject group at the beginning of the study, during the third week of treatment, at the completion of EBRT and 1 month after completing EBRT.^6,7

HUE Versus Sham HUE

Activation of chakras is believed to be the critical step in the HUE technique and can be performed only by a trained and qualified HUE instructor. The training to become a certified HUE instructor is strictly done through the HUESA under the guidance of Professor Theresa Thu Thuy Nguyen. Chakras activation for the HUE techniques can be achieved either physically or mentally, whereby a certified HUE instructor either places their hands on the patient, or sits in front of them and mentally focuses on the major nerve points (chakras) 2 to 7 (see Figure 1) for approximately 2 minutes (mental activation being similar in concept to establishing a Wi-Fi connection with the patient).

Figure 1.

Location of the 7 Chakras^a

In this study, we chose mental activation of the chakras by a certified HUE instructor, so the subjects were unable to determine which group (HUE or sham HUE) they were in. Education on the HUE or sham HUE technique was mandated for all eligible subjects after randomization. To reduce any potential bias, and to also establish a connection with the subject, both the subject and instructor sat in the same room with a free-standing room divider placed between them. The subject was able to hear the instructor but could not visibly see their face. The subjects were unaware whether they were placed in the HUE or the sham HUE group. The process of mental chakras activation takes approximately 2 minutes. During the 2 minutes, the HUE instructor communicated with the subject by verbalising the location and chakras that will be activated. The HUE instructor activated or did not activate, depending on the group that the subject was assigned to. All information regarding the HUE was given to the patient by the HUE instructor behind the freestanding room divider.

Following the mental activation process, the subjects were carefully guided step by step through the second and third constituent parts of the HUE technique by the certified HUE instructor. The second constituent involved the subject performing a series of 9 inhalations through the nose and exhalations out through the mouth, followed by a short 5-minute mindfulness meditation. Following this, each subject performed the third constituent part of the HUE technique, which is energy transfer. This involves focusing on chakras 7, 6, and 4 for 30 seconds.

For the subjects to remain blind to which group they were placed in, all subjects were taught the second and third constituent parts of the HUE technique. The only difference was the chakras activation process, which is believed to be the most crucial step in the success of the HUE technique. The randomization and subject allocation to the 2 groups were done by the data manager.

Once educated in the HUE technique, the subjects were asked to perform the steps they were taught twice daily for 5 minutes each, once at night before going to bed and then first thing the following morning. This was to be done throughout the course of EBRT treatment and including 1 month after completion of EBRT.

Weekly reviews were conducted by the treating radiation therapists who were not involved in the study to ensure compliance with the instructions of the HUE technique. If there were any difficulties, they could report them to the trained HUE practitioner. The radiation therapists were also responsible for collecting the HRQoL FACT-B patient questionnaires. The HUE instructor had no direct contact with the subjects after the educational session to avoid being coerced into divulging whether or not the chakras had been activated.

Outcomes Measurements

The HRQoL was measured by the FACT-B version 4 questionnaire⁷ (Appendix Part A). The validated FACT-B instrument consisted of the 4 primary quality of life domains of physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items) and the 9 items breast cancer specific (BCS) subscales developed to address treatment related concerns specific to the disease. The FACT-G consists of PWB, SWB, EWB, and FWB minus the BCS. As all FACT-B and subscales are scored so that better HRQoL is reflected in higher total scores. The ease of administration, brevity, reliability, and sensitivity to change are the reasons the FACT-B instrument is considered appropriate for use not only in clinical trials but also in clinical practice. The 23 items outcome summary measure trial outcome index-PWB/FWB/BCS (TOI-PFB) has also been shown to be reliable and responsive to change in the HRQoL domains and considered appropriate as a summary measure of these HRQoL subscales.

Data Analysis

The Mann-Whitney U test was used to compare the changes in the scores in the FACT-B, FACT-G, TOI-PFB, and the constituents subscales PWB, SWB, EWB, FWB, and BCS, relevant to both groups (experimental and control). The effects of HUE treatment were quantified using analysis of covariance (ANCOVA) models. All statistical analysis was done at significant level α = .05 and the differences were considered significant if P ≤ .05. In addition, confidence intervals for median change in scores relevant to specific periods were compared for the 2 treatments (sham HUE and HUE).

Clinical Relevant Changes in Outcome

Clinically relevant changes in outcome relating to HRQoL were determined priori.

Primary endpoints were as follows: A change of ≥10 units in the total FACT-B mean score over time from baseline (obtained at the beginning of EBRT) score, in patients with breast cancer undergoing treatment, was regarded as clinically relevant with respect to perceived improvement in quality of life.^8-10

Secondary endpoints were as follows: A change in the total FACT-B subscales (PWB, SWB, EWB, BCS, TOI) mean scores over time from the baseline score in the range of ≥ 8.0 units (FACT-G), ≥3.5 units (PWB), ≥3.5 units (FWB), ≥2.9 units (BCS), and ≥9.4 units (TOI) were also regarded as clinically significant. In addition, the effective size changes over time in the order of ≥ 0.5 standard deviation of the FACT-B HRQoL and subscales were considered clinically significant.^11-14

Results

A total of 32 early breast cancer patients were recruited into the study. Patients were randomized and assigned equally into the experimental group (n = 16) and control group (n = 16). This study report focuses on the changes in FACT-G, FACT-B, PWB, EWB, SWB, FWB, BCS, and TOI scores. In great detail, we analyzed the difference between the score obtained 1 month after completion of EBRT and the baseline score (obtained at the beginning of EBRT), because this change is relevant to the entire follow-up period of this study.

Exploratory Data Analysis

This analysis compares the control group to experimental group by age, ECOG score, and cancer stage (see Figure 2). Both groups are similarly distributed with respect to age, ECOG score, and cancer stage. The randomization of the patients achieved the desired outcomes.

Figure 2.

Comparison of Control Group With Experimental Group by Age, Cancer Stage, and ECOG Score^a

Change in HRQoL Outcomes 1 Month After the End of EBRT

Figure 3 compares the changes in FACT-G scores relevant to the sham HUE group with the changes in FACT-G scores relevant to the HUE group. Approximately half of the patients in the sham HUE group reported that their FACT-G score decreased, compared with less than one third of the patients in the HUE group. Both distributions are skewed positively for the HUE group and negatively for the sham HUE group; this fact influences significantly the means of the 2 groups. Therefore, means cannot be considered as reliable estimates for central tendency and it is appropriate to compare the 2 groups by their medians. The medians of the 2 groups are similar (see Table 1) and, not surprisingly, the Mann-Whitney U test returned insignificant P value equal to .16 (see Table 4).

Figure 3.

Comparison of the Changes in FACT-G Scores Achieved in the Experimental Group (HUE patients) With the Changes in the FACT-G Scores Achieved in the Control Group (Sham HUE Patients)

Table 1.

Descriptive Statistics (by Patient Group) for the Change in FACT-G Score^a

Group	n	Mean	SD	Median	Min	Max	Range	IQR	SE
Sham	16	-3.1	20.1	2	-48	22.7	70.7	28	5
HUE	16	8.4	13.4	4.9	-9.5	43	52.5	18	3.3

^aCalculated as the difference between the FACT-G score obtained 1 month after EBRT and the FACT-G score obtained before EBRT commencement.

Abbreviations: FACT, functional assessment of cancer therapy; SD, standard deviation; min, minimum; max, maximum; IQR, interquartile range; SE, standard error; EBRT, external beam radiotherapy.

Table 4.

Summary of the Descriptive Statistics for FACT-G, FACT-B, PWB, SWN, EWB, FWB, BCS, and TOI scores

	Group	n	Mean	SD	Median	Min	Max	Range	IQR	SE
FACT-G	Sham	16	-3.1	20.1	2	-48	22.7	70.7	28	5
	HUE	16	8.4	13.4	4.9	-9.5	43	52.5	18	3.3
FACT-B	Sham	16	-5.4	26.7	-2	-75	25.5	100.5	28.8	6.7
	HUE	16	14.7	16.6	9.8	-5.5	60	65.5	14.1	4.2
PWB	Sham	16	0.8	6.3	1	-12	12	24	6.2	1.6
	HUE	16	5	6	4.5	-1	24	25	7	1.5
SWB	Sham	16	-2.3	5.4	0	-14	4.7	18.7	3.9	1.3
	HUE	16	1.3	3.3	0.6	-4.7	8	12.7	4.2	0.8
EWB	Sham	16	-0.8	5.7	0	-10	14	24	6.5	1.4
	HUE	16	0.6	3.5	1	-8	6	14	3	0.9
FWB	Sham	16	-0.7	7.8	-0.5	-14	11	25	9	1.9
	HUE	16	4.9	5.1	4	-1	16	17	7	1.3
BCS	Sham	16	-1.7	8.8	-2	-27	8	35	9.5	2.2
	HUE	16	5.4	6	3.5	-3.5	17	20.5	10.5	1.5
TOI	Sham	16	-0.6	20.5	-2	-38	43.2	81.2	28.2	5.2
	HUE	16	14.3	13.5	12.2	-1	53	54	14.1	3.4

Abbreviations: FACT, functional assessment of cancer therapy; PWB, personal well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; BSC, breast cancer specific; TOI, trial outcome index; SD, standard deviation; min, minimum; max, maximum; IQR, interquartile range; SE, standard error.

ANCOVA Model

We proceeded by developing an ANCOVA model with regressors initial FACT-G score and treatment group (sham HUE or HUE). The developed model has a statistically significant coefficient for the treatment group equal to 10.85 (P ≤ .05), hence suggesting that (on average) the change in the FACT-G score for patients in the HUE group was approximately 11 points higher than the change in the FACT-G score in the sham HUE group. However, several observations (2 in the sham HUE group and 2 in the HUE group), which are noted in Figure 4, have been identified to have significant influence on the obtained results.

Figure 4.

Fitted Regression Lines Based on ANCOVA Model^a,b

The model diagnostic tools exposed further problems with the developed ANCOVA model. The assumption for equal variances across the investigated groups is violated suggesting that the developed model is unreliable for inferring confident conclusion regarding the effect of HUE on our primary endpoint.

Based on the visual inspection of the scatterplot on Figure 4 and the results from the model diagnostic, we developed updated ANCOVA model by using a dataset that excluded the identified 3 influential observations. In the updated model, the coefficient for treatment group was equal to 4.49 and it was associated with insignificant P value equal to .29. The obtained result for the effect of the treatment (sham HUE vs HUE) is visualised by Figure 5.

Figure 5.

Fitted regression lines based on ANCOVA model^a

The analysis in this section demonstrated that although the initial ANCOVA results are promising and show positive effects of HUE treatment on patients’ FACT-G scores, further analysis based on the larger sample sizes are necessary to confidently conclude whether HUE treatment has a significant positive influence on patient well-being.

Change in FACT-B Score

Analysis similar to the analysis for change in FACT-G was performed with respect to the change in FACT-B score. The P value returned by the Mann-Whitney U test was equal to 0.052, a moderate evidence for difference between the 2 groups (see Figure 6).

Figure 6.

Comparison of the Changes in the FACT-B Scores Achieved in the Experimental Group (HUE patients) With the Changes in the FACT-B Scores Achieved in the Control Group (Sham HUE Patients)

ANCOVA Model

Throughout the development of the ANCOVA model, we experienced problems similar to the problems relevant to the ANCOVA model for the change in the FACT-G score. The coefficient for the treatment group in the ANCOVA model changed significantly when 3 influential observations were excluded from the analysis (see Table 5). This fact is concerning, and we highly recommend further analyses based on larger data sets to verify the obtained result for quantifying the influence of HUE treatment on FACT-B scores. The results from the updated ANCOVA model suggested than if 2 patients have similar FACT-B scores before the start of the EBRT, then 1 month after the EBRT, the patient who undergoes HUE treatment is expected to have a FACT-B score that is approximately 11 points higher than the FACT-B score of patient who undergoes sham HUE treatment.

Table 5.

Summary of the Results From the Mann-Whitney U Tests and ANCOVA Models^a

		Initial ANCOVA Model		Undated ANCOVA Model
Score	Mann-Whitney U Test (P Value)	Adjusted Influence of HUE Treatment on the Score	P value Associated With the Coefficient of HUE Treatment	Adjusted Influence of HUE Treatment on the Score	P Value Associated With the Coefficient of HUE Treatment
FACT-G	.163	10.85	.05	4.49	.29
FACT-B	.052	19.68	.01	10.69	.03
PWB	.01	3.97	<.01	2.54	.02
SWB	.09	3.26	.03	2.36	.02
EWB	.20	2.13	.14	2.37	.06
FWB	.04	4.86	.01	5.74	<.01
BCS	.03	7.17	<.01	7.44	<.01
TOI	.02	14.87	<.01	13.40	<.01

^aThe highlighted cells note statistically significant P values at α = .05 and clinically significant change in scores.

Abbreviations: ANCOVA, analysis of variance; FACT, functional assessment of cancer therapy; PWB, personal well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; BSC, breast cancer specific; TOI, trial outcome index; HUE, human universal energy.

The analyses for comparison of changes in FWB, SWB, EWB, PWB, BCS, and TOI scores measured in the control group with changes measured in the experimental group were performed in a manner similar to the analysis relevant to FACT-G and FACT-G score. Table 4 shows the descriptive statistics for FACT-G, FACT-B, PWB, SWN, EWB, FWB, BCS, and TOI scores. Table 5 summarizes the obtained results from the Mann-Whitney U test and ANCOVA models.

Change in HRQoL Scores Over Time

Figure 7 illustrates how the FACT-G score has changed over the period starting at the beginning of the EBRT and finishing 1 month after the end of the EBRT. The figure displays a 95% confidence interval for the median change (ie, the magnitude of increase or decrease) in FACT-G score. All changes in the scores were computed by using a common definition of reference time point, which was the start of the EBRT. The confidence intervals for the medians of changes relevant to a specific period are located above the corresponding x-axis label. The confidence intervals relevant to a specific treatment group are displayed in the same color. It was decided to use confidence intervals that were determined by bootstrapping to limit the influence of the unusual cases in our small sample on the results. For similar reason, the comparison was based on medians and not on means. The figure shows that the regions of overlaps of the 2 corresponding confidence intervals constitute predominant parts of the ranges of the confidence intervals for median changes observed in the HUE treatment group.

Figure 7.

Summary of Changes in FACT-G Scores for the Sham HUE and HUE Groups

Similar analysis was performed for the other scores measuring HRQoL outcomes. The analysis considers what part (in %) of the range of the confidence interval for median change observed in HUE treatment group is overlapped by the confidence interval for median change observed in the sham-HUE treatment group. If this part is more than 50%, then it is reasonable to conclude that there is limited evidence for difference between the control and experimental groups with respect to the change in score. If the part is between 20% and 50%, then the evidence is weak, and if the part is less than 20%, then the evidence deserves further investigation. Table 6 summarizes results from this analysis.

Table 6.

Summary of the Results From Statistical Analysis

Evidence for Statistically Significant Difference Between the Control and Experimental Groups
Score	3 Weeks After the Start of RT	The End of RT	1 Month After the End of RT
FACT-G	Limited	Limited	Limited
FACT-B	Limited	Limited	Weak
PWB	Weak	Weak	Weak
SWB	Limited	Limited	Weak
EWB	Limited	Limited	Limited
FWB	Limited	Limited	Limited
BCS	Limited	Limited	Limited
TOI	Limited	Limited	Limited

Abbreviations: FACT, functional assessment of cancer therapy; PWB, personal well-being; SWB, social well-being; EWB, emotional well-being; FWB, functional well-being; BSC, breast cancer specific; TOI, trial outcome index; HUE, human universal energy; RT, radiation therapy.

Discussion

This statistical analysis investigated whether HUE treatment has a significant positive influence on patients’ HRQoL outcomes. The analysis compares the changes in FACT-G, FACT-B, PWB, EWB, SWB, FWB, BSC, and TOI scores measured in control group (sham HUE) with changes in the same scores measured in the experimental group (HUE). The change in a specific score was calculated as difference between the score obtained 1 month after the end of EBRT and the score obtained before the EBRT commencement.

The exploratory data analysis revealed that both groups (control and experimental) are similarly distributed with respect to important covariates and factors, such as age, initial scores obtained before the EBRT commencement, cancer stage, and ECOG score.

The changes in the scores relevant to both groups (control and experimental) were compared by using a Mann-Whitney U test. It was found that the independent samples to test was not appropriate for comparison because in most of the cases, the data were severely skewed. The effect of the HUE treatment was quantified by ANCOVA models. The majority of the developed ANCOVA models were found to be highly unstable and strongly influences by several unusual observations. Due to this fact, updated ANCOVA models were developed by fitting datasets that exclude highly influential cases.

The tests associated with FACT-G, SWB, and EWB scores returned insignificant P value, α > .05. The tests associated with PWB and FWB scores returned significant P values at α = .05, but the (adjusted) quantified influence of HUE treatment on these scores for PWB was less than the clinically significant threshold of 3.5 points, and the FWB clinically significant threshold of greater than 2.9 points. The tests associated with FACT-B, BCS, and TOI scores returned significant or close to significant P values and the (adjusted) quantified influence of HUE treatment on these scores was more than the accepted thresholds (5 points for BCS and 10 points for FACT-B and TOI) for clinical difference.

The comparative analysis of confidence intervals for median changes in scores observed in both groups showed that there are significant overlaps of the comparable confidence intervals. This fact confirms our conclusion that the statistically significant differences obtained by the ANCOVA analyses are most likely consequences of distorting effects of outliers in our data. Therefore, we recommend our initial findings to be verified by future studies using larger samples and longer follow-up periods, which will allow time to investigate if the benefits demonstrated over the short period of time sustain in the long term (ie, 1 y). In addition, this longer follow-up period will confirm whether the positive effects of HUE treatment are sustained because of previously reported carryover effects of HUE treatment.^14,15,16

CONCLUSION

This paper presented comparative analyses for HRQoL outcomes for 2 treatments: sham HUE and HUE, each one delivered to a separate group of patients.

The analyses demonstrated that although some of the results, such as the P values for the Mann-Whitney U tests and coefficients of HUE treatment in initial ANCOVA models, are promising and show positive effects of HUE treatment on subjects, further analyses based on the larger sample sizes are necessary to confidently conclude whether HUE treatment has a significant positive influence on patient well-being.

There is a promising future for the integration of this type of energy therapy as a complementary component to mainstream medicine, provided that there is more awareness, support, and opportunities for open collaboration, research, recognition, and acceptance from all level of stakeholders.

Table 2.

Descriptive Statistics (by Patient Group) for the Change in FACT-B Scores^a

Group	n	Mean	SD	Median	Min	Max	Range	IQR	SE
Sham	16	-5.4	26.7	-2	-75	25.5	100.5	28.8	6.7
HUE	16	14.7	16.6	9.8	-5.5	60	65.5	14.1	4.2

^aCalculated as the difference between the FACT-B score obtained 1 after EBRT and the FACT score obtained before EBRT commencement.

Abbreviations: FACT, functional assessment of cancer therapy; SD, standard deviation; min, minimum; max, maximum; IQR, interquartile range; SE, standard error; EBRT, external beam radiotherapy

Table 3.

Coefficients of HUE Treatment and the Associated P Values Relevant to (1) the Initial ANCOVA Models Fitted to the Entire Dataset, and (2) the Updated ANCOVA Model Fitted to the Modified Dataset^a

	Initial ANCOVA Modelb	Updated ANCOVA Modelc
Coefficient (HUE treatment)	19.68	10.69
P Value	.01	.03

^aThe coefficient (HUE treatment) quantifies the influence of HUE treatment on the FACT-B score obtained 1 month after the end of EBRT.

^bAll observations are considered in the analysis.

^cInfluential observations are excluded from the analysis).

Abbreviations: HUE, human universal energy; ANCOVA, analysis of covariance; EBRT, external beam radiotherapy.

Biographies

Josef-Binh Nguyen, PhD (TM), MD (TM), BASMRT, DipMgmt, is a senior radiation therapist in the Radiation Oncology Department at Royal Adelaide Hospital in North Terrace, Australia.

Eric Yeoh, MD, FRCP (EDIN), FRCR, FRANZCR, is a professor of medicine at the University of Adelaide in Adelaide, Australia.

Sonya Stephens, DASN, DBA, GradCertClinTRes, is the clinical trials data manager in the Radiation Oncology Department at the Royal Adelaide Hospital.

Ivan Iankov, PhD, BInfTech(Hons), BAppSc, is a statistician in the Radiation Oncology Department at the Royal Adelaide Hospital.

Appendix A. FACT-B Health-related Quality of Life Questionnaire

Scoring scales for each listed item

Not at all	A little bit	Some what	Quite a bit	Very much
0	1	2	3	4

PHYSICAL WELL-BEING (PWB)

GP1	I have a lack of energy
GP2	I have nausea
GP3	Because of my physical condition, I have trouble meeting the needs of my family
GP4	I have pain
GP5	I am bothered by side effects of treatment
GP6	I feel ill
GP7	I am forced to spend time in bed

SOCIAL/FAMILY WELL-BEING (SWB)

GS1	I feel close to my friends
GS2	I get emotional support from my family
GS3	I get support from my friends
GS4	My family has accepted my illness
GS5	I am satisfied with family communication about my illness
GS6	I feel close to my partner (or the person who is my main support)
GS7	I am satisfied with my sex life

EMOTIONAL WELL-BEING (EWB)

GE1	I feel sad
GE2	I am satisfied with how I am coping with my illness
GE3	I am losing hope in the fight against my illness
GE4	I feel nervous
GE5	I worry about dying
GE6	I worry that my condition will get worse

FUNCTIONAL WELL-BEING (FWB)

GF1	I am able to work (including work at home)
GF2	My work (including work at home) is fulfilling
GF3	I am able to enjoy life
GF4	I have accepted my illness
GF5	I am sleeping well
GF6	I am enjoying the things I usually do for fun
GF7	I am content with the quality of my life right now

BREAST CANCER SPECIFIC–ADDITIONAL CONCERNS (BCS)

B1	I have been short of breath
B2	I am self-conscious about the way I dress
B3	One or both of my arms are swollen or tender
B4	I feel sexually attractive
B5	I am bothered by hair loss
B6	I worry that the other members of my family might someday get the same illness
B7	I worry about the effect of stress on my illness
B8	I am bothered by a change in weight
B9	I am able to feel like a woman