Abstract
Context and objectives
To examine the impact of a complementary/integrative medicine (CIM) program on quality of life (QoL)-related concerns among patients scheduled for chemotherapy for breast and gynecologic cancer.
Methods
Chemotherapy-naïve patients were referred by their oncology healthcare professional to an integrative oncology program, where CIM is provided as part of palliative/supportive care. CIM treatments were tailored to patients’ preferences and leading concerns, and for most included acupuncture and mind–body–spirit modalities, which were usually co-administered in the week preceding the first chemotherapy cycle. Patients attending the program were considered part of the treatment group; those who chose to receive only standard supportive care as controls. Assessment of quantitative outcomes was conducted during the week before chemotherapy; at 24 h before and after the treatment; and at 1 week post treatment. For this purpose, the Edmonton Symptom Assessment Scale (ESAS) and Measure Yourself Concerns and Well-being questionnaire (MYCAW) were used. Qualitative assessment was based on short narratives at the end of the follow-up MYCAW questionnaire, which were analyzed with ATLAS.Ti software for systematic coding.
Results
Of the 55 patients referred, 31 (56%) underwent CIM treatments, with 24 controls. Both groups had similar baseline demographic and cancer-related characteristics. QOL-related outcomes were significantly less impaired following CIM treatments for ESAS fatigue scores (P = 0.013), depression (P = 0.005), and feeling of well-being (P = 0.027); and MYCAW scores for well-being (P = 0.005) and emotional distress (P = 0.02). Qualitative analysis detected both specific and non-specific effects of the CIM treatment regimen, most describing a reduction in pre-chemotherapy anxiety.
Conclusion
A patient-tailored CIM program, initiated within a week of the first chemotherapy cycle, may help reduce the severity of fatigue, depression, and impaired well-being among patients with breast and gynecological cancers.
Keywords: Integrative medicine, Complementary medicine, Chemotherapy, Quality of life, Supportive care, Anxiety
Introduction
Most chemotherapy regimens which are being administered to patients with breast and gynecologic cancer can significantly affect quality of life (QoL)-related outcomes, with wide range of bio-, psycho-, social, and spiritual concerns, the most apparent of which is often anxiety (Stephens et al. 2008; Jacobsen et al. 1993; Sjoquist et al. 2013). Anticipatory emotional distress in women about to undergo chemotherapy for breast cancer has been shown to significantly correlate with post-treatment distress (DiLorenzo et al. 1995). Pre-treatment expectations about chemotherapy-related nausea have been shown to be predictive of anticipatory nausea (Montgomery et al. 1998), and female patients about to undergo adjuvant breast cancer chemotherapy with low physical performance are more likely to present with more intense psychological distress and upper gastrointestinal symptoms following the treatment (Kim et al. 2009). Additional predictive factors for the development of QoL-related concerns in recently diagnosed patients with breast cancer also include a lower socio-economic status; additional co-morbidities; unemployment; and a history of avoiding psychological counseling (Ivanauskienė et al. 2014).
A number of behavioral interventions have been shown to help reduce anticipatory concerns and improve health-related QoL following the first chemotherapy cycle. These include progressive muscle relaxation training before and after chemotherapy, which can reduce both nausea and general mood disturbance, though no effect was observed with respect to anxiety (Molassiotis et al. 2002). Music therapy and verbal relaxation, administered prior to chemotherapy, have also been shown to be effective in reducing chemotherapy-induced anxiety, most prominently in patients with high levels of state anxiety (Lin et al. 2011). In patients with a recent diagnosis of breast cancer, a yoga intervention led to reduced levels of anxiety when given prior to surgery (Rao et al. 2009). Participation in a yoga program before chemotherapy for breast cancer was also shown to decrease the intensity of anticipatory nausea and post-chemotherapy-induced nausea, with respect to both frequency and intensity of these symptoms (Raghavendra et al. 2007). Other complementary and integrative medicine (CIM) modalities which have been associated with improved QoL when administered prior to the initiation of chemotherapy include acupuncture (Tas et al. 2014) and hand massage (Cutshall et al. 2017).
The present study set out to examine the impact of a patient-tailored CIM program, provided within a conventional oncology setting before and after chemotherapy, on QoL-related outcomes in patients with breast and gynecologic cancer. The implications of these effects on the integration of CIM in the peri-chemotherapy setting are discussed as well.
Methods
Study design and setting
The present study was prospective, controlled and non-randomized. Patients undergoing their first course of chemotherapy (chemotherapy-naïve) for breast or gynecologic cancer were approached and told about the study protocol. Chemotherapy was to be provided at the Oncology Service at the Lin and Zebulon medical centers of the Haifa and Western Galilee District, Clalit Healthcare Services, Israel. The Integrative Oncology Program (IOP) provides patients at these centers with a wide range of CIM modalities, whose goal is to provide relief from chemotherapy-related symptoms and concerns (Ben-Arye et al. 2012). CIM treatments are administered by a multidisciplinary team of medical (physicians and nurses), paramedical (social workers, occupational therapists, nutritionist) and non-medical CIM practitioners, all of whom are trained in integrative supportive oncology care.
Study population
Study recruitment took place from December 2014 to November 2016. Patients aged ≥ 18 years undergoing chemotherapy (neo-adjuvant, adjuvant or palliative) for breast or gynecological (ovarian, endometrial, or cervical) cancer were deemed eligible. Patients were referred to a CIM consultation, within the 2 weeks preceding the first chemotherapy cycle by their oncologist, nurse oncologist, or social worker. The consultation was provided by one of the integrative physicians (IPs) at the IOP, a conventional physician (MD) dually trained in CIM and supportive cancer care. At the end of this first IP consultation, a patient-tailored CIM treatment program is designed, based on the patients’ health-related QoL concerns as well as an evaluation of their expectations; present and prior experience with complementary therapies; and willingness to experience unfamiliar CIM modalities. The goals of treatment are co-established with the patient, and are based on the research findings regarding the effectiveness and safety of these treatments. The IP invariably includes a discussion on dietary changes; the effectiveness and safety of herbs and non-herbal dietary supplements; and lifestyle interventions which can improve QOL, such as moderate physical activity and stress reduction (with mind–body therapies). At the end of the initial consultation, the IP recommends a treatment program which includes one or more of the CIM modalities provided at the IOP, which include acupuncture, mind–body–spirit therapies (e.g., guided imagery, anthroposophic music therapy, spiritual care), and manual/movement therapies (e.g., acupressure, reflexology, Feldenkrais and the Paula method). Prior to the first chemotherapy cycle, acupuncture and mind–body–spirit therapies are the most frequently recommended modalities, especially when anxiety or insomnia are the patient’s leading concerns. Often, the IP consultation is followed by a 30-min treatment session which begins with insertion of acupuncture needles (often in the Yin-Tang, P-6, ST-36, SP-6, and LIV-3 acupoints), which is followed by relaxation and breathing therapies, during which the acupuncture needles are manipulated at regular intervals. The initial CIM treatment may be followed by additional sessions, depending on the interval between the IP consultation and the timing of first chemotherapy cycle. Treatment in each of these interactions is personalized and adapted according to the patient’s leading concerns and preferences. Additional CIM treatments are offered at each of the subsequent chemotherapy cycles, with the outcomes of these interventions reported elsewhere. All CIM treatments are provided without charge.
Patients who had been referred to and attended the IP consultation were considered as the treatment group; those who chose to receive only standard supportive care as controls (Fig. 1). Throughout the study period, patients in the control group were repeatedly reminded that they could decide at any time to attend the IP consultation and undergo CIM treatments. This minimized the potential for a selection bias which may have been created by a lack of awareness about the IOP service. Both treatment and control groups received standard conventional supportive care, which included an hour-long meeting with a nurse oncologist who explained the potential side effects of the chemotherapy agents, as well as a meeting with a psycho-oncologist, during which the patient has an opportunity to discuss anxiety-related issues. In addition to psychological interventions, patients may be provided with pharmacological options for their anxiety and other QoL-related symptoms.
Fig. 1.
Study algorithm
Safety of the IP recommendations and CIM treatments are monitored and documented in the patient’s medical file throughout the study period, from the initial IP consultation and through each CIM visit. The safety-risk assessment includes an examination of potentially negative interactions between dietary supplements and conventional drugs, as well as assessment of the CIM treatments using validated risk assessment tools such as the acupuncture-related adverse event report form (Chung et al. 2015).
Quantitative assessment of patients’ QoL-related concerns and expectations
Patients in both the treatment and control groups were assessed at baseline during the week preceding the first cycle of chemotherapy, with QoL-related concerns measured using the Edmonton Symptom Assessment Scale (ESAS) (Bruera et al. 1991), which ask patients to score 9 symptoms as well as their feeling of well-being (on a scale of 0–10), this for the previous 24 h period; and the Measure Yourself Concerns and Well-being (MYCAW) (Paterson et al. 2007), which asks patients to list and score (from 0 to 6) their two most important concerns, and to reflect on their experience with the CIM treatment regimen in the follow-up MYCAW questionnaire, regarding the previous 7-day-period (written narratives). A second assessment was conducted at 24 h prior to treatment; the third at 24 h post treatment; and the final assessment at 5–7 days post chemotherapy.
At the baseline, visiting patients were also asked to describe their experience (past and present) with the use of CIM, for both concerns which were related to their cancer, as well as those that were not. Patients were also asked to discuss their health beliefs regarding the existence of a mind–body connection; their understanding of the effectiveness and/or risks of complementary medicine; and their expectations from the CIM treatment regimen.
Qualitative assessment of study outcomes
Qualitative assessment of the effects of the CIM treatment program was based on the short narratives appearing in the follow-up MYCAW questionnaire [which asks “what has been the most important aspect (of the therapeutic process) for you?”], as well as from statements entered in the electronic medical file (Keshet et al. 2015).
Excerpts from the patient narratives were analyzed using the textual analysis computer package Atlas-Ti (Version 8.0, Scientific Software Development GmbH, Berlin, Germany). Excerpts from the narratives were first read verbatim to derive codes, marking the precise words from the text which captured key concepts, and then collating those quotes which were related to the various codes. The codes were then sorted into categories based on their relationship to each other (Todres et al. 2009). Categories were merged and codes arranged and grouped into meaningful clusters, with a tree diagram designed enabling the arrangement of these categories in a hierarchical structure.
Data analysis
The sample size was calculated using the OpenEpi program (Microsoft). Determination of the study sample size and power analysis were based on the hypothesis regarding the effects of the IO intervention on patients’ QOL, as was the case in previous studies (Kerner et al. 2017; Shalom-Sharabi et al. 2017). It was determined that to assess the impact of the CIM treatments on QoL, at least 23 patients would be needed in each arm of the study. This would allow an alpha error of 0.05 and beta error of 0.2 (power 80%) to detect a difference of three points on a 0–6 point MYCAW scale in the treatment group compared with 0.5 points in controls. Fisher’s exact test was used to detect differences in the prevalence of categorical variables and demographic data between both groups. Mann–Whitney U test was conducted to compare treatment and control group baseline ESAS scores and between-group analysis. T test was used to determine within-group changes in ESAS scores. P values of < 0.05 were considered statistically significant.
Ethical considerations
The study protocol was approved by the Ethics Review Board (Helsinki Committee) at the Carmel Medical Center in Haifa, Israel; and registered at ClinicalTrials.gov (NCT01860365). Participation was voluntary, and no payment or other incentive was offered as an incentive.
Results
Description of the study groups
A total of 57 patients with breast or gynecological cancers who were scheduled for chemotherapy were recruited, of which 33 expressed an interest in undergoing the IP consultation and subsequent CIM treatments (Fig. 1). Of these, 31 actually attended the IP consultation (one patient was treated in another oncology center; the other began chemotherapy before the initial IP consultation was able to be scheduled). Patients in both treatment and control groups underwent baseline QoL assessment during the week prior to chemotherapy (n = 55); at 24 h prior to chemotherapy (20 in the treatment group, 19 controls); at 24 h post-chemotherapy (25 in the treatment group, 19 controls), and at 5–7 days post-chemotherapy (29 in the treatment group, 24 controls).
Baseline characteristics of study groups
The demographic, cancer and oncology treatment-related characteristics of the treatment and control groups are presented in Table 1. Demographic parameters (age, language, country of birth, distance of residence from research centers, education, occupation, religion, religiosity, familial status, and presence of caregiver) were similar in both groups, though the treatment arm had higher levels of income (P = 0.007). Both groups had a similar distribution of cancer type (breast vs. gynecological), recurrence rates, evidence of metastasis, and oncology treatment regimens. Patients in the treatment group reported higher rates of past use of CIM for cancer-related concerns (P = 0.001), with rates of CIM use for non-cancer-related concerns similar in both groups. Both groups had similar attitudes regarding the connection between the body and soul, and for the effectiveness and risks of complementary medicine.
Table 1.
Characteristics of patients in the treatment and control groups
| Characteristic | Treatment group n = 31 | Control group n = 24 | P values |
|---|---|---|---|
| Age: mean ± SD | 55.7 ± 13.3 | 60.3 ± 10.5 | 0.17 |
| Language | 0.06 | ||
| Hebrew | 20 (65%) | 11 (46%) | |
| Arabic | 8 (26%) | 6 (25%) | |
| Others | 3 (9%) | 7 (29%) | |
| Country of birth: Israeli born | 20 (67%) | 13 (54%) | 0.41 |
| Residence: Haifa (vs. periphery) | 11 (36%) | 8 (33%) | 1.00 |
| Education: high-school and academic | 26 (87%) | 18 (75%) | 0.31 |
| Occupation: unemployed (vs. employed) | 18 (60%) | 19 (79%) | 0.15 |
| Income: average and below (vs. high) | 18 (62%) | 23 (96%) | 0.007 |
| Religion: Jewish (vs. others) | 23 (74%) | 17 (71%) | 1.00 |
| Religiosity: secular (vs. religious) | 15 (50%) | 10 (42%) | 0.59 |
| Familial status: married (vs. others) | 26 (84%) | 17 (71%) | 0.33 |
| Caregiver: spouse (vs. others) | 21 (72%) | 17 (71%) | 1.00 |
| CAM medicine usea | |||
| Prior use (non-cancer related) | 17 (55%) | 9 (38%) | 0.28 |
| Cancer diagnosis related | 14 (45%) | 1 (4%) | 0.001 |
| CAM-related health beliefsb | |||
| Mind body connection | 6.7 ± 0.75 | 5.8 ± 1.8 | 0.063 |
| Perceived CAM effectiveness | 5.8 ± 1.4 | 5.0 ± 1.8 | 0.21 |
| Perceived CAM risk | 1.2 ± 0.53 | 2.4 ± 1.9 | 0.08 |
| Cancer site: breast (vs. gynecological) | 27 (87%) | 19 (79%) | 0.48 |
| Cancer recurrence: yes | 2 (7%) | 2 (8%) | 1.00 |
| Evidence of metastasis: yes | 2 (7%) | 5 (21%) | 0.22 |
| Chemo type | |||
| Adriamycin and cytoxan (vs. others) | 18 (58%) | 12 (52%) | 0.78 |
aCAM Complementary alternative medicine
bData based on a Likert scale scored from 1 (very slightly agree) to 7 (agree very much)
CIM treatments
Following the initial IP consultation, 29 patients in the treatment group were treated with the following CIM modalities (prior to chemotherapy): acupuncture (14 patients, 48%); mind–body therapies, including anthroposophic music therapy (14, 48%); touch/movement therapies (11, 38%); and herbal/nutritional interventions (9, 31%). The majority of patients (16, 66%) received two or more of these therapies, which were administered in parallel.
Quantitative assessment
ESAS and MYCAW scores (24 h) for both study arms are presented in Table 2. Baseline scores for MYCAW and most ESAS scales were similar in both groups, except for pain, for which the scores were more severe in the treatment group. Between-group analysis indicated that the deterioration in QoL was significantly less pronounced in the treatment group, according to ESAS scores for fatigue (P = 0.013), depression (P = 0.005), and feeling of well-being (P = 0.027).
Table 2.
Within- and between-group changes in treatment and control groups
| Assessment scale | Treatment group n = 31 n (%) | Control group n = 24 n (%) | P values* | ||
|---|---|---|---|---|---|
| Pre-chemo | Post-chemo | Pre-chemo | Post-chemo | ||
| Edmonton Symptom Assessment Scores (ESAS) subscalesa | |||||
| Pain | 3.5 ± 3.1 | 4.4 ± 3.0 | 1.5 ± 2.5 | 4.7 ± 3.5 |
P 1 = 0.013 P 2 = 0.17 P 3 < 0.0001 P 4 = 0.03 |
| Fatigue | 3.84 ± 3.5 | 6.00 ± 3.15 | 2.13 ± 2.9 | 6.83 ± 2.31 |
P 1 = 0.077 P 2 = 0.013 P 3 < 0.001 P 4 = 0.013 |
| Nausea | 1.03 ± 2.37 | 3.73 ± 3.68 | 0.35 ± 1.30 | 3.86 ± 3.72 |
P 1 = 17 P 2 = 0.003 P 3 = 0.002 P 4 = 0.59* |
| Depression | 3.64 ± 2.94 | 4.30 ± 2.90 | 3.13 ± 3.03 | 5.56 ± 2.92 |
P 1 = 0.53 P 2 = 0.33 P 3 = 0.002 P 4 = 0.005 |
| Anxiety | 5.51 ± 3.27 | 4.87 ± 2.96 | 4.69 ± 3.54 | 4.96 ± 3.45 |
P 1 = 0.38 P 2 = 0.17 P 3 = 0.73 P 4 = 0.14 |
| Drowsiness | 2.48 ± 2.51 | 4.06 ± 3.11 | 3.00 ± 3.30 | 5.69 ± 3.13 |
P 1 = 0.84 P 2 = 0.018 P 3 = 0.001 P 4 = 0.36 |
| Shortness of breath | 1.41 ± 2.36 | 2.33 ± 2.86 | 0.69 ± 1.60 | 1.21 ± 2.76 |
P 1 = 0.12 P 2 = 0.22 P 3 = 0.4 P 4 = 0.88 |
| Appetite | 2.38 ± 2.73 | 4.63 ± 3.31 | 3.56 ± 3.30 | 4.69 ± 3.50 |
P 1 = 0.19 P 2 = 0.002 P 3 = 0.23 P 4 = 0.24 |
| Sleep | 4.93 ± 2.76 | 5.37 ± 2.45 | 3.56 ± 3.25 | 4.83 ± 2.93 |
P 1 = 0.10 P 2 = 0.57 P 3 = 0.11 P 4 = 0.063 |
| Feeling of well-being | 4.54 ± 2.74 | 5.90 ± 2.29 | 3.43 ± 2.74 | 6.47 ± 1.95 |
P 1 = 0.15 P 2 = 0.035 P 3 < 0.001 P 4 = 0.027 |
| Measure yourself concerns and well-being (MYCAW) subscalesb | |||||
| First concern | 5.37 ± 1.12 | 4.79 ± 1.78 | 5.46 ± 0.99 | 5.40 ± 0.98 |
P 1 = 0.77 P 2 = 0.037 P 3 = 0.86 P 4 = 0.47 |
| Second concern | 5.22 ± 1.28 | 4.61 ± 1.96 | 5.50 ± 0.90 | 5.41 ± 0.79 |
P 1 = 0.50 P 2 = 0.039 P 3 = 0.83 P 4 = 0.48 |
| Emotional concern | 5.80 ± 0.69 | 4.68 ± 1.85 | 5.25 ± 1.05 | 5.58 ± 0.79 |
P 1 = 0.085 P 2 = 0.014 P 3 = 0.46 P 4 = 0.02 |
| Well-being | 3.17 ± 1.51 | 3.93 ± 1.22 | 2.88 ± 1.99 | 4.81 ± 1.04 |
P 1 = 0.58 P 2 = 0.015 P 3 ≤ 0.001 P 4 = 0.005 |
*P1 = compared treatment and control group baseline scores in initial visit (pre-chemo);
P 2 = within treatment group score changes from initial- to post-chemo visit;
P 3 = within control group score changes from initial- to post-chemo visit;
P 4 = between treatment and control group changes from initial- to post-chemo visit
aESAS symptoms range from 0 (lowest severity) to 10 (greatest severity)
bMYCAW concerns range from 0 (lowest severity) to 6 (greatest severity)
Between-group analysis of the MYCAW scores indicated a more significant improvement in the treatment group for emotional concerns (P = 0.02), and a less-pronounced deterioration in well-being (P = 0.005). Within-group analysis found that the two most important concerns for patients on the MYCAW questionnaire improved only in the treatment group (first concern, P = 0.037; second concern, P = 0.039), with no improvement observed with controls.
Qualitative assessment
Two types of themes were identified from the qualitative analysis of the short patient narratives, from either the MYCAW questionnaire or electronic patient files. The first was the sense that the CIM program had helped with specific symptoms and concerns. These included a feeling that the treatments “strengthened” them, both physically and emotionally, providing a sense of calmness, a sense of confidence:
“When I came to the integrative medicine department I felt very weak, mentally. After an hour-long treatment session with acupuncture and Reiki treatments, I felt much stronger... The hours before my chemotherapy were calmer, more safe …with more strength... I felt that my breathing was more free” (a 51-year-old patient undergoing adjuvant chemotherapy for breast cancer).
One respondent wrote that she felt the CIM treatments helped her “cope with the side effects of chemotherapy”, which included nausea and xerostomia (dry mouth). Eight respondents reported a reduction in pre-chemotherapy anxiety, with two patients stating that the CIM treatments helped reinforce their decision to undergo chemotherapy.
The second type of themes which were reported by a number of patients included non-specific outcomes which were associated with the CIM treatment program. Patients described an environment in which they found a patient–practitioner interaction which was “holistic” and “humanistic”.
“Knowing that the program made me feel at home was very encouraging, very supportive… The approach here is aimed at treating the person, not just some patient who is scheduled for chemotherapy” (a 63-year-old patient scheduled for neo-adjuvant treatment for ovarian cancer).
Some of the patients addressed the inter-personal rapport with their CIM practitioners. This interaction was described as one which offered them “optimism”, a “sense of confidence, of protection”, and “faith”:
“The treatment was quite amazing… it felt like nothing bad had happened to me today… I felt that I am not in a hospital, but somewhere else…somewhere where the colors are more optimistic…” (a 51-year-old patient undergoing neo-adjuvant chemotherapy for breast cancer).
Safety assessment
Throughout the study, no CIM-related adverse events or any tolerability issues were reported.
Discussion
The present study explored the impact of a patient-tailored CIM program on female patients’ concerns and QoL-related outcomes prior to the initial chemotherapy cycle for breast or gynecological cancer. Using both quantitative and qualitative analysis, it was shown that patients who attended an IP consultation and CIM treatment program had lower severity scores for emotional-related concerns, this when compared to controls who received standard supportive care alone. Patients in the CIM-treated group also reported a less severe deterioration in their QoL following the first chemotherapy cycle, especially for symptoms such as fatigue, depression and feeling of well-being. An earlier study of the IOP service found that patients with gynecological cancer who adhered to the CIM treatment program reported a significantly greater decrease in cancer-related fatigue (on ESAS scores) than patients who did not (Ben-Arye et al. 2015). At the same time, present study did not find any statistically significant beneficial effects with the CIM intervention for anticipatory pre-chemotherapy emotional concerns (on MYCAW) or depression (on ESAS), nor for ESAS anxiety scores. Future research will need to examine the quantitative effects of CIM on post-chemotherapy anxiety, especially when it is related to adverse effects of the chemotherapy regimen.
The findings of the qualitative analysis of patient narratives was found to support those of the quantitative analysis for the impact of the CIM program on emotion-related concerns. The qualitative findings may have also provided insight into possible elements of the CIM setting which may explain the effects of these treatments. These include two seemingly contradictory effects of the CIM treatments, with patients describing their experience as both “providing strength” (physical and emotional) as well as a “calmness”, most frequently in association with pre-chemotherapy anxiety. These two experiences may reflect a feeling of empowerment on the part of the patient, as well as a feeling of security which was promoted by the CIM practitioner–patient interaction, with its emphasis on the patient-centered integrative approach. This approach insures that the CIM treatments are individually tailored to each patient’s concerns, while keeping in tune with their willingness to experience different CIM therapies within the oncology setting.
Our earlier research of the IOP service, in which CIM is provided as part of conventional supportive and palliative care, has also led to an understanding that the present therapeutic setting can result in both specific and non-specific effects (Paterson et al. 2007; Kerner et al. 2017; Shalom-Sharabi et al. 2017). In the present study, non-specific effects of the treatment program included a rapport which developed between the patients and their CIM practitioners. This rapport may have played an important role in the concurrent specific effects of the treatment program (i.e., symptom relief and improved QoL), especially emotional symptoms such as anxiety and depressed mood.
The present study has a number of limitations which need to be addressed in future research. The first is the potential selection bias which is characteristic of the pragmatic non-randomized methodology. While both study groups had nearly identical baseline demographic and cancer-related parameters, the rates of complementary medicine use for cancer-related concerns was higher in the treatment group, though this was not expressed in patients’ description of their health beliefs that include perceived CIM effectiveness, safety, and beliefs regarding mind–body connection (Table 1). Nevertheless, the pragmatic approach makes it more likely that the findings reflect a “real-world” clinical setting, in which CIM is being used to help reduce the symptom load prior to chemotherapy. The QOL assessment tools used in the present study examine subjective parameters, which may be considered a factor which precludes the reaching of any conclusions regarding the effectiveness of the IO intervention. Nevertheless, patient-reported outcome measures (PROMs) are considered to be a valid approach to evaluating patient QOL-related concerns (Kotronoulas et al. 2014). In addition, generalizability of the current trial may be relevant to only those cancer centers where CIM is provided at a relatively early phase (i.e., prior to chemotherapy) with an IP for consultation and designing of a patient-tailored treatment plan. Taking into consideration the other study limitations, particularly the small sample size, it is clear that a larger study is required before reaching any conclusions on the effectiveness of the IO intervention. This would enable the researchers to explore differences in effect size, comparing standardized versus individualized integrative care.
In summary, the present study suggests that a patient-centered CIM intervention can help improve emotional concerns in a subset of patients with breast and gynecological cancer, when initiated prior to the first cycle of chemotherapy. While the observed effects were related more to pre-chemotherapy emotional concerns, they may also be present in the post-chemotherapy setting, especially when CIM is targeted at reducing chemotherapy-induced QOL-related concerns such as depression and fatigue, though less-regarding anxiety.
Acknowledgements
We would like to thank Ms. Ronit Leiba for her assistance in statistical analysis.
Funding
This study was not funded by any source.
Compliance with ethical standards
Conflict of interest
Eran Ben-Arye declares that he has no conflict of interest. Hadeel Dahly declares that she has no conflict of interest. Yael Keshet declares that she has no conflict of interest. Jamal Dagash declares that he has no conflict of interest. Noah Samuels declares that he has no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
Informed consent
Informed consent was obtained from all individual participants included in the study.
Footnotes
The research was conducted as part of the second author’s research project in the Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Eran Ben-Arye and Hadeel Dahly are regarded as co-first authors based on their equal contribution to this study.
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