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Hee J. Yoo
Se H. Ahn
Efficacy of progressive muscle relaxation
Sung B. Kim
Woo K. Kim
training and guided imagery in reducing
Oh S. Han chemotherapy side effects in patients
with breast cancer and in improving
their quality of life
might be to treat acute nausea/vomiting effectively and thus session of their six-cycle CT session and measured how
to decrease the patients anxiety about anticipatory side much PMRT and GI reduced their CT side effects. Based on
effects. In the study of Molassiotis et al. [20], each patient in the study of Molassiotis et al. [20], we asked the patients to
the experimental group received a PMRT session with the self-report their home records during 3 days after CT to see
therapist 1 h before chemotherapy administration (at hos- their PNV.
pital) and on each of the next 5 days (in the patients homes) More effective management of treatment-related NV
for a total of six sessions. After chemotherapy, delayed could also improve patients QoL [23]. Fairclough et al.
nausea was at its highest point on day 3 of chemothera- [15] had used three times repeated measures to compare the
py, declining steadily thereafter; delayed vomiting was its HRQoL of the patients in six 28-day cycles of cyclophos-
highest point on day 2 after chemotherapy [20]. phamide, doxorubicin, and 5-fluorouracil (CAF) with that
There also have been studies on post-CT nausea and of the patients in a 16-week regimen. They limited the
vomiting (PNV) in CT-nave patients with breast cancer assessment to that before therapy within 14 days of start
[14, 20, 23]. In preventing post-infusional NV, the use of of chemotherapy. The assessment during treatment of 4
effective antiemetics is the primary approach for dealing [6] of CAF, the assessment of following therapy was to
with subsequent anticipatory effects [27]. occur 4 months after the completion of therapy. Based on
The rate of ANV is much less than observed in older the Fairclough et al. study [15], we assessed the QoL of
studies, which used less satisfactory antiemetic programs. the patients using three repeated measures at baseline, 3
ANV is difficult to control by pharmacological means, months, and 6 months after their receiving CT.
whereas behavioral therapies involving relaxation can be The hypotheses of the study are as follows:
used to effectively treat ANV [1]. If we reduce patients
1. The PMRT and GI group will significantly reduce the
ANV with PMRT and GI, this may reduce patients PNV,
negative emotions (anxiety, depression, and hostility),
thus making it difficult to determine the effect of reduction
intensity of anticipatory side effects (anxiety, nausea,
methods on PNV.
and vomiting), and postchemotherapy side effects than
Along with physiological and psychological assess-
the control group.
ments, it is important to determine the effects of treatment
2. At 3 months after chemotherapy, the PMRT and GI
on patients quality of life (QoL). In patients with advanced
group will significantly improve in emotional well-
breast cancer who underwent adjuvant CT, the patients with
being; at 6 months after chemotherapy, the PMRT and
higher QoL scores in their QoL assessment before their
GI group will significantly improve in general and
treatment predicted a better response to CT [16, 26]. The
breast-cancer-specific well-being.
potential psychological, sexual and physical dysfunction
caused by both the diagnosis and treatments in breast cancer
can have a deleterious impact on the quality of a womans
life [14]. Health-related quality of life (HRQoL) can be Patients and methods
profoundly affected by breast cancer treatment [13]. There-
fore, monitoring quality of life in breast cancer should be An experimental, randomized controlled trial was designed
mandatory part of follow-up in clinical trial. Assessment to examine the effectiveness of the PMRT and GI in a group
of QoL can help identifying those patients who might of patients with breast cancer. To keep the sample as ho-
profit from psychosocial interventions [14]. mogeneous as possible, all subjects consisted of the out-
Disease-specific scales, such as the Functional Assess- patients of the same type of cancer who were receiving CT
ment of Cancer TherapyBreast (FACT-B) [5, 9], have for the first time at the Department of Oncology in Asan
been found effective in assessing the general and disease- Medical Center in Seoul. The subjects were randomly allo-
specific well-being of patients with breast cancer. The ef- cated to experimental and control groups by simple random
fects of the use of PMRT on anxiety and QoL in patients sampling. Randomization was carried out by using the en-
with colorectal cancer after stomach surgery were evaluated velope method [10]. Each patient had to pick an envelope
with repeated measures assessment over 10 weeks post- out of a box of 70 identical envelopes.
stomach surgery [10]. Nevertheless, there has been no study The sample size was calculated using the formula for
on the efficacy of PMRT and GI training along with estimating sample size for repeated measures analysis of
assessing the QoL of patients with breast cancer who re- variance [11]. As the previous literature is in favor of PMRT
ceive CT. [10], one-tailed test was used and the significance level was
The aim of the study was to evaluate the effects of PMRT set at 0.05 with the power set at 80%. With the estimation of
and GI in reducing chemotherapy side effects and in im- an average of 37% attrition in longitudinal studies over 10
proving the QoL of patients with breast cancer. weeks [3], the required sample size would be at least 35 in
The subjects in our study were a homogeneous group of each group.
patients with breast cancer, who received six cycles of cy- In Korea, most patients with breast cancer usually are
clophosphamide, methotrexate, and 5-fluorouracil (CMF). in their forties and fifties (about 5060% of all patients
We had performed PMRT and GI on the patients in each with breast cancer), which are different from the cases in
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Western countries; cases of Korean patients with cancer 4. Ability to read and write Korean
who were both over 60 years old and receiving CT were 5. Agreement to give written informed consent
very few in this study (n=3). When we started this study, we
excluded only the patients who were in breast cancer stage Patients were excluded if they had a known CNS metas-
IV with a life expectancy of <6 months, and no restrictions tases, a history of intestinal obstruction, prior mental ill-
were made with regard to the patients age or performance ness, and end-stage malignancy.
status. As the study went on, there was a tendency for the Antiemetic therapy consistent with current guidelines
patients older than 60 years to drop out of our study, pri- was used in treating these patients. All patients received
marily because they were physically very weak and their antiemetic regimens including dexamethasone and a 5-HT3
families were not cooperative to participate in this study. antagonist. Antiemetics were given 30 min before the che-
Especially, Korean caretakers of the patients over 60 years motherapy was administered. Metoclopromide 15 mg and
old were usually the patients family members, and they lorazepam 1 mg p.r.n. were also prescribed for each patient
had always complained of arriving at the hospital 1 h earlier for their use at home, and the patients were told to take them
than the time due of their patients receiving CT to partic- when necessary.
ipate in this study. So we made a decision to drop them
because the number of their cases (n=3) was very few.
However, owing to the time limit and unexpected events Procedures
during the study period, such as noncooperation of the
caretakers or the CT dropout because of the patients se- Patients willing to participate in the study were given a
rious physical weakness, we had to randomize only 60 pa- short interview with two clinical psychologists to be told
tients into a PMRT and GI group (n=30) and a control group the purpose of the study and an information sheet. A pilot
(n=30). The groups were well matched for demographic study lasting for 1 month was conducted before the main
variables such as age, educational level, and marital status study, and minor adjustments were made to the quiet room,
(Table 1). questionnaire, and design. The study was carried out over a
Inclusion criteria were the following: period of 20 months, starting in early 2002. Both control
and experimental groups were seen 1 h before the initiation
1. Diagnosis of primary breast cancer, surgery within 12
of chemotherapy and were guided to the quiet room. All
months, nave to CT
patients completed questionnaires relating to their negative
2. Female, age 30 years and above, and suitability for
emotions (anxiety, depression, and hostility) and the QoL.
chemotherapy
3. Patients with one to three involved axillary lymph
nodes receiving cytotoxic therapy consisting of six cy-
PMRT and GI group
cles of CMF every 28 days
In the first session, experimental group patients were led
to a relaxation training room approximately 1 h before re-
Table 1 Sociodemographic and clinical characteristics ceiving CT treatment. Each patient also received a cassette
PMRT and Control group Significance
tape with a record of her own first PMRT session for home
GI group (n=30)
use. Each patient in the experimental group received a
PMRT and GI session with the therapist 1 h before che-
(n=30)
motherapy administration (at hospital) and on each of the
Age (years), mean (SD) 42.91(10.1) 44.00 (7.2) NS next chemotherapy cycles (at hospital), for a total of six
Education (years), 11.91(3.2) 11.67 (4.8) NS PMRT and GI sessions. The PMRT and GI group received
mean (SD) the antiemetic treatment according to the standard protocol
Employment NS 30 min before chemotherapy.
Homemaker 19 (63.3) 19 (63.3) The majority of patients experiencing postinfusional
Full time 5 (16.7) 4 (13.3) symptoms indicated that their symptoms persisted for more
Part time 6 (20.0) 7 (23.3) than 24 h and were worse a day or two after CT admin-
Marital status NS
istration [27]. We took account of the possibility of delayed
Single 3 (10.0) 2 (6.7)
emesis and vomiting, so that we asked the PMRT and GI
group to do home practice at least more than 3 days with the
Married 25 (83.3) 26 (86.6)
recorded tape we had provided them. Patients were asked to
Widowed 2 (6.7) 2 (6.7)
rate the extent to which they vomited or felt anxious or
Stage of disease NS
nauseous on 7-point scales, ranging from 0 (not at all) to 6
II 22 (73.3) 22 (73.3)
(extremely), and the number of vomiting episodes. There
III 8 (26.7) 8 (26.7)
were 12 consecutive blocks of time, each lasting approxi-
NS nonsignificant mately 6 h (morning, afternoon, evening, and night).
829
The control group consisted of patients who did not par- The FACT-B scale Version 4 is a disease-specific evalua-
ticipate in the PMRT and GI, underwent the identical CT tion for patients with breast cancer. It consists of 36 items,
treatment, or completed the same self-report forms in the subdivided into four primary QoL domains [physical
hospital and at home. The control group received the anti- (PWB), social/family (SFWB), emotional (EWB), and func-
emetic treatment according to the standard protocol 30 min tional (FWB)] and containing additional concerns for breast
before chemotherapy. cancer (BCS). The FACT-B was translated by employing
the standard Functional Assessment of Chronic Illness
Therapy (FACIT) translation methodology [5, 9]. Korean
Measurement scales FACT-Bs internal consistency of both the subscales and
total FACT-B were high: PWB (0.81), SFWB (0.86), EWB
Multiple Affect Adjective Checklist (0.79), FWB (0.83), FACT-G (0.87), BCS (0.67), and total
FACT-B (0.90) [28].
The Multiple Affect Adjective Checklist (MAACL) is a
self-report index of anxiety (20 items), depression (20
items), and hostility (30 items) [29]. Participants marked The technique of PMRT and GI
their level of affect for each item on a yes/no scale. Inter-
nal consistency of the three subscales was high (Kuder PMRT includes progressive muscle relaxation (tensere-
Richardson reliability coefficients=0.78, 0.80, and 0.74, lease) of 15 of 16 groups of muscles (right hand and fore-
respectively, with a testretest reliability of 0.74, 0.81, and arm, right upper arm, left hand and forearm, left forearm,
0.77, respectively) in this study. forehead, upper cheeks and nose, lower face, neck, abdo-
men, right upper leg, right calf, right foot, left upper leg, left
calf, left foot) according to PMRT techniques [3], but
Records of patients and nurses modified according to the area of pain in the chest, shoul-
ders, and upper back.
The patients who were participated in this study did not like Therapists tried to establish positive relationships with
to check too many items on anxiety, nausea, and vomiting at their patients. The therapist directed the patient on which
hospital and at their homes, so we decided to make the group of muscles to tense and release each time and ex-
number of the items short and thus to construct a 7-point, plained the deep breathing instructions [20]. In the second
one-item, Likert scale method because the patients had to session, it was emphasized that the ability to relax is a
check the items 12 times within 3 days. learned skill, requiring active participation and frequent
A rating scale was constructed as described previously practice by the patient [4]. Generally the procedures and
[18]. Immediately before CT, patients were asked to rate the methods of the first and second sessions were virtually
extent to which they vomited or felt anxious or nauseous on identical. GI was initiated after the third session of PMRT,
7-point scales, ranging from 0 (not at all) to 6 (extreme- during which patients were taught to imagine a peaceful
ly). All of the patients in this study were outpatients, and scene of their own choice to enhance relaxation. After
they had received the CT in the outpatient clinic and went PMRT, the patient was guided in the use of visual imagery
home on the same day. The nurses who participated in the to achieve an even deeper state of relaxation. Generally the
patient CT completed the assessment of NV immediately procedures and methods from the third to the sixth session
after the patient had received CT. The nurses could not were identical. At the fifth session, we notified the patients
know which group the patients were allocated to. After they that the next session would be the last session and that the
checked the questionnaires, they only attached them to their treatment would be terminated after the sixth session. We
charts. Only the principal investigator (HJ Yoo) knew also told them to ask us any question at the last session if
which group the patients were allocated to. Nurses who they had any problems during their session period.
administered the CT were also asked to rate these param-
eters independently on identical scales.
Statistical analyses
Home records of the patients Descriptive statistics are summarized in Table 1. The data
from the six training sessions were analyzed by the methods
The 3-day postchemotherapy home record rating scale we below:
used was identical to that above, with the addition of the To analyze patients emotional states immediately after
number of vomiting episodes at home. There were 12 con- PMRT and GI and immediately before CT, data from the
secutive blocks of time, each lasting approximately 6 h MAACL from each six training session were analyzed by 2
(morning, afternoon, evening, and night). (PMRT and GI vs control)6 (sessions) mixed ANOVA.
830
Table 4 Mean scores of the FACT-B at baseline, 3 months after, and 6 months after the patients received CT
Baseline 3 months after CT 6 months after CT
PMRT Control PMRT Control p PMRT Control p
PWB 19.17 (5.44) 19.38 (4.35) 19.88 (5.13) 19.21 (4.98) NS 22.77 (4.88) 18.88 (5.36) <0.05
SFWB 17.03 (4.91) 17.30 (4.32) 16.35 (5.12) 15.58 (4.89) NS 16.55 (6.12) 14.75 (6.10) NS
EWB 18.40 (3.18) 16.94 (5.46) 19.38 (3.94) 17.01 (3.49) <0.05 20.37 (2.97) 17.55 (2.89) <0.05
FWB 14.72 (4.96) 12.16 (4.45) 15.43 (4.72) 15.11 (5.22) NS 17.61 (6.06) 16.72 (3.56) NS
FACT-G 69.32 (13.51) 65.80 (13.22) 71.00 (14.38) 67.73 (12.85) NS 76.61 (16.02) 67.92 (11.14) NS
BCS 24.09 (4.54) 22.07 (3.88) 24.42 (4.73) 21.05 (3.69) NS 25.38 (4.84) 20.26 (4.96) <0.01
FACT-B 93.41 (16.90) 87.88 (14.96) 97.01 (18.24) 88.13 (16.18) NS 102.00 (19.94) 88.18 (14.02) <0.05
Although the PMRT and GI group was significantly ef- treatments may have similar outcomes in terms of response
fective during the treatment sessions, their effectiveness and survival, but can produce very different effects on
decreased somewhat after terminating PMRT and GI. Al- emotional well-being [14]. These results show that PMRT
though the PMRT and GI group reported lower levels and GI improved the QoL of patients with breast cancer
of vomiting immediately before CT than did the control who had received CT.
group, the two peak points of vomiting tendency were the
first and third sessions.
We found that the PMRT and GI group showed generally Conclusion
lower levels of PNV and number of vomiting episodes.
Generally, NV levels in both groups showed a significant Patients receiving PMRT and GI showed reliable improve-
but gradual decrease over time. Although the PMRT and GI ments in self-reported measurements of ANV and PNV,
group experienced less frequent vomiting episodes than the both in the hospital and at home. Administering nurses also
control group, they reported more vomiting episodes on reported that the PMRT and GI group showed less nausea
the last day than on the second day. Furthermore, the two and vomiting than the control group. These results indicate
groups showed significant differences in the number of that PMRT and GI have a positive effect on patients with
vomiting episodes on the first and second days, but showed breast cancer, reducing ANV and PNV and improving their
little difference on the third day. QoL. The limitations of this study were the use of a rel-
There were no significant differences in the QoL between atively small number of patients and a relatively short-term
the two groups in baseline. Three months after CT, EWB of follow-up. Increasing the number of the cases and follow-
the PMRT and GI group was significantly higher than that up for at least 1 year is therefore needed.
of the control group. In almost 3 months, we can expect that These findings may reveal time-efficient and cost-effec-
patients would be experiencing the cumulative effects of tive methods for reducing ANV and PNV in patients with
chemotherapy without yet experiencing the psychological breast cancer receiving CT.
lift that occurs at the end of treatment [15] (Table 4).
Six months after CT, not only EWB but BCS and the Acknowledgements This work was supported by a grant from the
FACT-B total were significantly higher in the PMRT and Asan Institute for Life Sciences (2001-156).
GI group than in the control group. The range of possible
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