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ARTICLE IN PRESS

European Journal of Oncology Nursing (2005) 9, 56–63

www.elsevier.com/locate/ejon

A pilot study of a supervised group exercise


programme as a rehabilitation treatment for
women with breast cancer receiving adjuvant
treatment
Anna Campbella, Nanette Mutriea,*, Fiona Whiteb, Fiona McGuirec,
Nora Kearneyd

a
Institute of Biomedical and Life Sciences, Glasgow G12 8RZ, UK
b
Macmillan Education Unit, Nursing and Midwifery School, University of Glasgow, Glasgow G12 8LW, UK
c
GGNHSB, Dalian House, 350 St Vincent St, Glasgow G3 8YT, UK
d
Cancer Care Research Team, Department of Nursing and Midwifery, University of Stirling,
Stirling FK9 4LA, UK

KEYWORDS Summary This pilot study examined whether exercise as an adjunctive rehabilita-
Breast cancer; tion therapy could benefit women who have early stage breast cancer and are
Exercise; currently receiving chemotherapy/radiotherapy. The study was designed as a
Fatigue; randomised controlled trial (RCT). Physical functioning, fatigue and Quality of Life
(QoL) outcomes were evaluated pre and post a 12-week intervention. The results
Quality of life
showed that after 12 weeks the women who participated in the exercise programme
(n ¼ 12) displayed significantly higher levels of physical functioning and reported
higher QoL scores than the controls (n ¼ 10). Changes in fatigue and satisfaction with
life favoured the intervention group but did not reach significance. These results are
encouraging and suggest that a structured group exercise programme during
adjuvant treatment is a safe, well tolerated and effective way of providing physical
and psychological health benefits to women during treatment for early stage breast
cancer. Since this was a pilot study the numbers did not allow appropriately powered
analyses of some variables of interest and favoured relatively young and socio-
economically advantaged women. Future studies need to address these issues and
determine if these short-term benefits can be sustained.
& 2004 Elsevier Ltd. All rights reserved.

Zusammenfassung In dieser Pilotstudie wurde untersucht, ob Korper . .


ubungen als
erga. nzende Rehabilitationsmanahme fur .
. Frauen von Vorteil sein konnten, die erst
vor kurzem an Brustkrebs erkrankt waren und gegenwa. rtig mit Chemotherapie bzw.
Strahlentherapie behandelt werden. Die Untersuchung wurde als kontrollierter
Zufallsversuch (RCT: randomised controlled trial) ausgelegt. Vor und nach einem
. ochigen
zwolfw . .
Ubungsprogramm .
wurden allgemeine Korperfunktionen, Erm-
.udungserscheinungen (Fatigue) und Lebensqualita. t (QoL: Quality of Life) gemessen
und bewertet.
.
Die Resultate zeigen, dass die Frauen, die am Ubungsprogramm teilgenommen
hatten (n ¼ 12), am Ende der zwo. lf Wochen im Vergleich zur Kontrollgruppe (n ¼

*Corresponding author. Tel.: þ 44-141-357-7563; fax: þ 44-141-337-2389.

1462-3889/$ - see front matter & 2004 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejon.2004.03.007
ARTICLE IN PRESS
A pilot study of a supervised group exercise programme as a rehabilitation treatment 57

.
10) ein signifikant hoheres .
Niveau bei den Korperfunktionen .
aufwiesen und hohere
QoL-Werle erzielten. Vera. nderungen hinsichtlich der Variablen ’Erm-
.
udungserscheinungen’ und ‘Zufriedenheit mit dem Leben’ sahen die Programm-
gruppe im Vorteil, bewegten sich aber nicht im Signifikanzbereich.
Diese Untersuchungsergebnisse sind ermutigend und legen es nahe, gut aufge-
.
baute Korper .
ubungsprogramme . Gruppen als eine sichere, effektive und
fur
bereitwillig akzeptierte Manahme zu betrachten, um Frauen im Fruhstadium . der
Brustkrebserkrankung schon wa. hrend der Behandlung Hilfe zur Erhaltung der
physischen und psychischen Gesundheit zukommen zu lassen. Da es sich jedoch
nur um eine Pilotstudie handelte, konnten wegen der beschra. nkten Anzahl von
.
Probandinnen einige Variable von Interesse nicht grundlich genug analysiert werden.
Weiter waren einschra. nkend vor allem jungere,
. .
bezuglich ihres sozio-o. konomischen
.
Status privilegierte Frauen betroffen. In zukunftigen Untersuchungen sollten diese
.
Fragen berucksichtigt werden. Zudem sollte gekla. rt werden, ob die festgestellten
kurzfristigen positiven Auswirkungen la. ngerfristig von Bestand sein konnen.
.
& 2004 Elsevier Ltd. All rights reserved.

Introduction health that are typically diminished in patients


with cancer (Bouchard et al., 1994). Recent studies
Breast cancer is the most commonly occurring have reported that exercise has a positive effect on
cancer among women and in Scotland accounts the physiological outcomes of women with breast
for 25% of the female cancer burden excluding non- cancer such as fatigue (Mock et al., 2001),
melanoma skin cancer (Cancer Surveillance Group, functional capacity (MacVicar et al., 1989), body
2000). Incidence of breast cancer increased by composition (Winningham et al., 1989) and nausea
27.4% over the period 1986–1995 (Cancer Surveil- (Winningham and MacVicar, 1988) and psychological
lance Group, 2000). For any woman free from other outcomes such as locus of control, mood states,
life-threatening disease, the risk of developing self-esteem, QoL and satisfaction with life (Cour-
breast cancer up to the age of 74 is approximately neya and Friedenreich, 1997; Mock et al., 2001;
8% (Harris et al., 1998). Survival has improved over Segar et al., 1998; Kolden et al., 2002). However,
the last 20 years in Scotland with a 75.3% 5 year many of the earlier studies were methodologically
relative survival reported for those diagnosed limited, using quasi-experimental, cross-sectional
between 1991 and 1995 compared to 56% for those or retrospective research designs. To date, only
diagnosed between 1968 and 1972 (Harris et al., three research groups (all based in North America)
1998). This has placed an increased emphasis on (Mock, 2001; Winningham and MacVicar, 1988;
addressing the quality of life (QoL) issues for Segal et al., 2001) have conducted randomised
women with a breast cancer diagnosis. A recent controlled trials on the effects of exercise following
meta-analysis (Meyer and Mark, 1995) has shown breast cancer diagnosis. Their results, most of
that there are a number of QoL interventions that which are based on individually supervised exercise
may help individuals cope with the cancer experi- or home-based self-reported exercise, show that
ence including cognitive-behavioural therapies, the women who exercised reported less fatigue and
information and educational strategies, individual emotional distress as well as a higher functional
counselling, psychotherapy and social support. ability and QoL than the control groups. Only two
However, one common feature among these inter- studies have examined the feasibility of a struc-
ventions is that they do not adequately address the tured group exercise programme during treatment.
physical and functional problems encountered by Kolden et al. (2002) recruited 40 women over the
patients such as fatigue, nausea and weight gain. age of 45 with breast cancer to participate in a
An intervention that may address a broad range of course of group exercise training (GET) delivered in
QoL issues following breast cancer diagnosis is a structured format three times a week for 16
exercise (Courneya and Friedenreich, 1997). The weeks. The results showed that the participants
rationale for the use of exercise as a QoL interven- experienced significant physical and psychological
tion for patients with cancer is strong. Exercise is health benefits by attending the group exercise
associated with improved cardiovascular fitness, sessions. In this study the participants served as
pulmonary function and self-esteem, and with their own controls and therefore the efficacy of
decreased anxiety and depression – all aspects of GET was not fully established. Segal et al’s study
ARTICLE IN PRESS
58 A. Campbell et al.

(Segal et al., 2001) of women with breast cancer already exercising vigorously three times a week
receiving adjuvant therapy compared self-directed for 20 minutes or more were excluded from the
and supervised exercise with usual care in a study but invited to attend the exercise sessions.
controlled clinical trial. They found decreased Women were made aware of the programme
physical functioning in the control group and through their consultant oncologist, breast care
increased physical functioning in both intervention nurse and radiotherapy and chemotherapy nurses
groups. However there were no significant differ- and were invited to join the study around the time
ences in QoL scores. Only the supervised group of 2nd or 3rd chemotherapy cycles and during 2nd
showed increased aerobic capacity and reduced and 3rd weeks of radiotherapy treatment. This
body weight. ensured that treatments had been established with
Although the literature is strongly suggestive of a no particular problems noted.
positive link between physical exercise and QOL
following breast cancer diagnosis, there are a Instruments
number of shortcomings that need to be addressed:
* There have been few studies with control groups Sociodemographic data
equivalent on all relevant criteria to the experi- Standard demographic data and physical activity
mental condition. In spite of the challenges of level prior to cancer diagnosis was noted. DEPCAT
conducting a randomised controlled trial with an score, an index of deprivation, was derived from
intervention that may be viewed as desirable, post code (Morris and Carstairs, 1991). The DEPCAT
research using this design is needed to minimise score obtained ranges from 1, indicating the lowest
the bias inherent in previous studies. level of deprivation, to 7 indicating the highest
* In most studies, the results were based on self- level of deprivation. Clinical information regarding
reported levels of exercise or on individually the treatment regime was requested from the
supervised exercise. More studies are needed healthcare team.
with objective indicators of physical exercise,
such as attendance at structured fitness classes, Psychological/quality of life
in order to study whether exercise in a group Cancer-specific quality of life was measured using
setting influences QOL changes and/or exercise Functional Assessment of Cancer Therapy – General
motivation and adherence. (FACT-G) and Functional Assessment of Cancer
* Many of the earlier intervention studies com- Therapy – Breast (FACT-B) scales (Cella et al.,
menced many months or even years after the 1993): FACT-G was the primary outcome of interest
end of treatment for breast cancer. and is intended for all patients with cancer; FACT-B
is intended for patients with breast cancer. The
This pilot study attempts to address these issues.
FACT B includes 5 well-being subscales: physical,
The study is also the first in the United Kingdom
social, emotional, functional and breast cancer
conducted within the National Health Service and
specific. These scales present a series of state-
linked with a local authority.
ments to the respondent who answers on a 5-point
scale of agreement from ‘‘not at all’’ to ‘‘very
much’’. An example from the functional section
Methods would be ‘‘I am able to work (include work at
home)’’.
Recruitment of subjects Satisfaction with Life Scale (SWLS) is a global
QoL tool (Diener et al., 1985). It is a short 5-item
The procedures for this study were approved by the instrument with questions such as ‘‘in most ways
West Ethics committee, North Glasgow University my life is close to my ideal’’ with a 7-point scale of
Hospitals NHS Trust. Women undergoing treatment agreement. SWLS was developed to assess satisfac-
for newly diagnosed breast cancer were recruited tion with the respondent’s life as a whole. The
from a large West of Scotland Cancer Centre during scale does not assess satisfaction with life domains
a defined recruitment period. Eligible women had such as health or finances but allows subjects to
received breast surgery and were currently receiv- integrate and weight these domains in whatever
ing adjuvant radiotherapy/chemotherapy. Women way they choose. SWLS shows good convergent
were excluded from the study if they had con- validity with other scales and with other types of
current major problems such as uncontrolled assessments of subjective well-being yet the scale
cardiac or hypertensive disease, respiratory disease has shown sufficient sensitivity to be potentially
and cognitive dysfunction. Women who were valuable to detect change in life satisfaction during
ARTICLE IN PRESS
A pilot study of a supervised group exercise programme as a rehabilitation treatment 59

the course of clinical intervention. The SWLS is that discomfort occurs. Baseline and post-test
recommended as a complement to scales that focus measures were used to assess changes in physical
on psychopathology or emotional well-being be- condition resulting from exercise. The 12-minute
cause it assesses an individual’s conscious evalua- walk test has been successfully used in studies with
tive judgment of his or her life by using the person’s women with breast cancer (Schwartz et al., 2001)
own criteria. and is used extensively in cardiac rehabilitation as
Perceived expectations and benefits of total care a measure of functional ability. Using an estimate
package – this questionnaire was designed specifi- of standard walking pace, in which 1 mile [1.6
cally for this study. At baseline subjects were asked kilometres] can be covered in 20 minutes at an
(using a standard 5-point Likert scale) to indicate average pace or 15 minutes at a fast pace, we have
their expectations that the total care package will estimated that an average person will be able to
affect their QoL (a great deal, some improvement, complete around 960–1280 m in 12 minutes, de-
not sure, not much, not at all). At week 12, pending on their pace.
subjects were asked to indicate whether the total
care package had helped to improve their QoL.

Fatigue Design and procedures


Revised Piper Fatigue Scale (PFS) (Piper et al.,
1998). The PFS is a 22-item, 10 point self-report The study was a 2 (group) by 2 (time points)
scale that measures overall fatigue. This scale randomised controlled trial with a structured
consists of 22 questions divided into four subscales exercise programme as the treatment variable. If
that measure the following dimensions of fatigue: a woman expressed an interest in taking part in
behavioural/severity, affective meaning, sensory the study, an appointment was made to meet
and cognitive/mood. Each question was scored on the senior researcher, at which point informed
an 11-point numerical scale. The overall score and consent was obtained. The volunteer then com-
each subscale score is given on a scale of 0–10 with pleted all baseline questionnaires and performed
0 indicating no fatigue and 10 indicating the most the 12-minute walking test. The women were
severe fatigue. The scores for each question are randomly allocated by computer-generated num-
summed and then divided by the total number of bers into one of two groups in equal proportion.
questions 22 to obtain an overall average score for The randomisation was stratified by treatment
the questionnaire. The PFS has demonstrated (chemotherapy, radiotherapy or combination). Let-
validity and reliability in a number of other studies ters were sent to participants General Practi-
of patients with cancer. tioners’ (GPs) to inform them of the person’s
involvement in the study.
Physical The time points were pre-treatment (baseline)
The Scottish Physical Activity Questionnaire [SPAQ] and 12 weeks. The exercise programme lasted 12
(Lowther et al., 1999) was used to measure self- weeks because there is evidence that exercise can
reported physical activity. Respondents were asked be effective during this time-frame (Marcus et al.,
to recall all moderate or vigorous activity com- 1994) and it provided sufficient time to encourage
pleted at home, at leisure or at work over the subjects in the exercise group to become indepen-
previous 7 days. The SPAQ has been shown to be dent exercisers.
quick and easy to complete and practical for use A demographic questionnaire was completed at
with large subject numbers in a variety of situa- baseline. The SPAQ, 12-minute walk test, FACT-G,
tions. Lowther et al. (1999) developed this ques- FACT-B, SWLS, PFS, and the expectations & benefits
tionnaire for use with Scottish populations and questionnaires were completed at entry and at 12
showed that it had good test–retest reliability and weeks. The questionnaires were self-administered
strong concurrent validity with the stage of and returned to the researcher in a sealed
exercise behaviour change model. envelope.
The 12-minute walking test (McGavin et al.,
1976) was performed as a measure of physical Treatment groups
function. This test is a measure of the distance in
metres an individual can cover in 12 minutes. The Group A – usual care plus monitoring
test is conducted indoors on a level surface using a This group received usual care from the healthcare
stopwatch. The subject is instructed to walk as far team and completed the questionnaires and walk-
as possible in 12 minutes but not to be concerned if ing test at baseline and week 12. At the end of the
she needs to slow down or stop to rest at any time study period they were assisted by the senior
ARTICLE IN PRESS
60 A. Campbell et al.

researcher in constructing their own personalised Results


exercise plan using recognised person-centred
guidelines (Loughlan and Mutrie, 1995) and invited Recruitment and adherence to exercise
to join the local general practice (GP) exercise programme
referral scheme.
Over a recruitment period of 12 weeks, 22 women
undergoing chemotherapy and/or radiotherapy
Group B – usual care plus adjunctive group were recruited into the study. 19 women out of
exercise treatment 22 completed the study. One woman discon-
Women assigned to this group received usual care tinued due to travel constraints, one due to
and also attended a supervised exercise programme secondary cancer and one declined to provide
twice weekly for 12 weeks. The exercise interven- the reasons for discontinuing. There were no
tion was based on Courneya’s exercise prescription adverse reactions to taking part in the exercise
guidelines for cancer patients and survivors intervention and participants completed an aver-
(Courneya et al., 2000). The classes consisted of a age of 70% of the total number of sessions
warm-up, 10–20 minutes exercise (which varied (SD ¼ 720%).
from week to week and included walking, cycling, Table 1 shows the comparisons of the two groups
low-level aerobics, muscle-strengthening exer- at baseline. There were no baseline differences
cises, circuits etc.), a cool down and relaxation between groups for the physical functioning, QoL,
period. The women’s heart rates were monitored fatigue and demographic characteristics. However,
throughout the class to ensure that they were those then allocated to the exercise group were
exercising at a moderate level (60–75% age- more positive in their expectations of the effect
adjusted heart rate maximum). Each week, for 6 that the total care package would have on their
weeks, a specific theme was addressed, with the quality of life.
intention of guiding the women into becoming Table 2 shows the differences in the measure-
independent exercisers. These themes were based ments post-intervention between the exercise
on a model of behaviour change (Marcus et al., group and the control group. After 12 weeks, the
1994) and addressed the health benefits from women who participated in the exercise pro-
exercise, enhancing self-efficacy, overcoming bar- gramme reported significantly higher levels of
riers, achieving a supportive environment, setting physical functioning (12-minute walking test),
goals and finding appropriate activity options in the physical activity (SPAQ) and general QoL (FACT-G)
community (Mutrie et al., 1997). The 6-week block than the controls. Changes in fatigue and satisfac-
was repeated on a rolling basis allowing all tion with life favoured the intervention group but
participants to hear the same themes. At the end did not reach significance.
of the study, the women were assisted in con-
structing an individual exercise programme tailored
to suit each person’s needs to encourage them to
move on to exercising independently. They were Discussion
also invited to join the local GP exercise referral
scheme. An important finding of the study was that the
women recruited into the exercise group were able
to consistently and progressively increase physical
Data analysis activity levels over the course of chemotherapy and
Data were analysed using SPSS for Windows (Version radiotherapy treatments whereas the usual care
9). Baseline subjects’ characteristics in the two group experienced a progressive decrease in
groups were compared using independent t-tests physical activity levels. The women recruited into
for continuous variables and w2 tests for categorical the study demonstrated a high level of motivation
variables. For primary analysis, the change in FACT- and adherence to engage in the structured group
G scores between baseline and 12 weeks for each exercise. There was only a 13% dropout during the
participant was calculated. The primary outcome 12 weeks and all participants completed an average
of change over baseline at 12 weeks in FACT G score of 70% of all sessions.
was compared between the two randomised groups By the end of this study’s 12 week programme the
using a two sample two-sided t-test. Secondary women in the exercise group spent on average, an
measures of FACT-B, SWL, SPAQ, PFS, 12-minute additional hour almost each day carrying out
walking distance were analysed in the same way. routine activities such as walking, housework and
Alpha level was set as Po0.05. leisure pursuits whereas the controls remained at
ARTICLE IN PRESS
A pilot study of a supervised group exercise programme as a rehabilitation treatment 61

Table 1 Comparison of randomised groups at baseline.


Measurements Exercise group Control group
Number of subjects 12 10
Age (years) 48 [710] 47 [75]
Treatment
Chemotherapy 3 3
Radiotherapy 2 4
Combination 7 3
Carstairs Deprivation Index 3.0 3.8
SPAQ (minutes of physical activity 330 [7171] 421 [7191]
per week)
12-minute walking test (metres) 1026 [7237] 1087 [7136]
Piper Fatigue Scale 5.24 [72.2] 4.87 [72.5]
Fact-B 92.3 [725] 96 [719]
Fact-G 72 [718] 79 [715]
Satisfaction with Life Scale 4.45 [71.5] 3.68 [71.9]
Perceived expectation of treatment 1.3 [70.5] 0.3 [71.3]
packagen
n
P ¼ 0.02.

Table 2 Change in measurements from baseline to 12 weeks.


Measurements Exercise group Control group P-value
(10 women) (nine women) group
Mean (SD) Mean (SD) comparison
12-minute walk (metres) þ 328 [7145] 5 [7139] 0.001nn
SPAQ (minutes) 343 [7190] 5 [7214] 0.003nn
FACT B þ 14.3 [719.8] 1.7 [719.4] 0.094
Subscales
Functional wellbeing þ 3.67 [75.24] 1.5 [75.97] 0.062
Physical wellbeing þ 4.33 [74.03] 1.2 [77.61] 0.066
Breast cancer specific þ 2.44 [76.93] þ 1.2 [75.14] 0.666
FACT G þ 11.9 [713.8] 2.9 [716.1] 0.046n
Piper Fatigue Scale 2.11 [72.3] 0.25 [72.5] 0.115
Satisfaction with Life Scale þ 0.4 [70.9] 0.02 [70.7] 0.315
Perceived benefits of treatment 1.78 [70.4] 0.44 [71.7] 0.004nn
package
n
P ¼ o0.05.
nn
P ¼ o0.01.

the baseline level of physical activity. The self- With FACT-B, which includes breast cancer
reported levels of physical activity at baseline for specific concerns, no significant differences were
both groups and at follow up for the control group observed between groups although the results
were similar to those found in sedentary popula- favoured the intervention. However, when changes
tions (Lowther et al., 1999). The intervention group over 12 weeks were analysed for FACT-G, the
increased their activity to levels associated with general quality of life questionnaire for cancer
regularly active people and improved their 12- patients, the difference between groups was
minute walk distance to what would be expected of significant, with the physical and functional sub-
those walking at a fast pace. This increase in scales showing the most difference between
routine activities correlated (Pearson’s correlation groups. The women in Kolden’s (2002) group
0.456; P ¼ 0.025) with the significant increase in exercise study showed similar QoL improvements –
the distance the women could walk in 12 minutes they also found a significant improvement in the
after the programme – a measurement of physical FACT functional subgroup. However, in Segal’s RCT
fitness. (Segal et al., 2001), no significant differences
ARTICLE IN PRESS
62 A. Campbell et al.

amongst the groups in FACT-G and FACT-B were use this evidence to consider exercise as part of
reported over a 26-week intervention period. rehabilitation during adjuvant therapy.
In this pilot study, the mean difference between
groups for the change in FACT G score over the 12
weeks was about 15 units. This change represents a
shift from requiring bed rest half the waking day to
Acknowledgements
being fully ambulatory with symptoms (Brady et al.,
We would like to acknowledge the support of
1997). These differences in physical functioning
Greater Glasgow NHS trust for the funding to
and QoL between the two groups therefore may
complete this pilot study.
have a practical significance in that limitations
during and after treatment may prevent the women
getting back to work, coping with family life, etc.
All the participants enthusiastically endorsed the References
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