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Support Care Cancer (2010) 18:1597–1603

DOI 10.1007/s00520-010-0962-2

SHORT COMMUNICATION

A randomised pilot of a self-help workbook intervention


for breast cancer survivors
Lisa Beatty & Melissa Oxlad & Bogda Koczwara &
Tracey D. Wade

Received: 3 December 2009 / Accepted: 20 July 2010 / Published online: 29 July 2010
# Springer-Verlag 2010

Abstract Keywords Breast cancer . Psychosocial adjustment .


Purpose The aim of this study is to evaluate the efficacy of Self-help workbook . Survivorship
a self-help workbook for improving adjustment for breast
cancer survivors.
Methods An RCT compared the workbook (n=20) with no- Introduction
workbook controls (n=20). Coping, traumatic stress and
quality of life were measured at baseline, then 3 and The psychological impact of breast cancer has been well
6 months later. documented [1], with long term sub-threshold depression,
Results No interactions were found. A significant group anxiety, impaired quality of life (QOL) [2–4], occurring in
main effect was found for venting coping; controls used up to 30% of patients. Group psychosocial interventions
less venting coping than workbook participants (p=0.034). targeting these issues have demonstrable efficacy and cost
A significant time main effect was obtained for cognitive effectiveness [5], however only 14–21% of Australian
functioning (p=0.003). Reliable change indices showed a women elect to participate [4]. Attendance barriers include
trend towards a protective effect across all coping measures (1) not feeling comfortable with a group setting, (2)
for workbook participants compared to controls. Qualitative preferring to deal with issues alone and (3) access
feedback suggested that participants felt well supported by difficulties for rural patients.
the intervention, but would have preferred receiving it Self-help interventions provide solutions to these barriers
during treatment. and have received recent empirical attention. Stiegelis et al.
Conclusions While trends showed some promise for im- [6] developed an information booklet for patients undergo-
proving coping, endorsement for the workbook was not ing radiotherapy. Patients with high illness uncertainty and
obtained. The difficulties encountered in recruiting survi- low perceived control experienced less tension, anger and
vors and the resulting implications regarding the feasibility depression 3 months after receiving the booklet than
of offering self-help resources to this population are controls. Distress was measured cross-sectionally, thus
discussed. changes over time could not be examined. However the
psychological literature suggests that providing information
alone is insufficient to facilitate change, and active
cognitive and emotional processing of the cancer is
Submitted to: Supportive Care in Cancer required to lower distress [7]. Angell et al. [8] provided
L. Beatty (*) : M. Oxlad : T. D. Wade
this opportunity in their workbook~journal based on
School of Psychology, Flinders University, supportive–expressive therapy principles for American
GPO Box 2100, Adelaide, South Australia, Australia women with breast cancer. Three interactions were
e-mail: lisa.beatty@flinders.edu.au obtained: (1) workbook participants who had completed
treatment experienced fewer post-traumatic stress disorder
B. Koczwara
Department of Medical Oncology, Flinders Medical Centre, (PTSD) symptoms compared to usual care; and rural
Adelaide, South Australia, Australia practice patients reported (2) decreased fighting spirit and
1598 Support Care Cancer (2010) 18:1597–1603

(3) increased emotional venting if they did not receive the were English speaking and aged 18 years or over.
workbook. Participants were recruited from a single institution
While promising, neither self-help study conducted a between March 2004 and August 2006. This study was
longer term follow-up, treatment engagement was not approved by the Flinders Clinical Research Ethics
measured, and interactive opportunities could be increased. Committee.
The current study therefore developed and evaluated a self-
help workbook targeting treatment completion, in order to Procedure
replicate Angell et al.'s [8] design and findings. It was
hypothesised that workbook participants would show Women were recruited by one oncologist (BK) and
significantly greater improvements compared to usual care research nurse. Computer-generated block randomisation
(no-workbook) controls over the 6-month study period, in in blocks of two was utilised (‘treatment’ and ‘control’).
the primary outcome, coping; and secondary outcomes, Allocation was implemented sequentially through num-
PTSD and QOL. bered containers, and the sequence was concealed.
Figure 1 illustrates the flow of participants through the
study. Consenting participants were informed of their
Methods treatment allocation by the research nurse prior to
completing baseline questionnaires (T1), as this was a
Participants requirement of the institution. Upon receiving this ques-
tionnaire, the workbook was posted out to treatment
Participants were women with stage I or II breast cancer, participants. The research coordinator LB assessed treat-
who had completed treatment within the past 3 months, ment compliance with WB participants by telephone 1 and

Fig. 1 Flow diagram of partic-


ipants' involvement in the rand- Assessed for eligibility
omised trial for breast cancer (n=55)
survivors Excluded (n=13)
- Refused to participate
(n=3)
- Verbally consented but
did not provide subsequent
Randomized written consent
(n=42) (n=10)

Allocated to intervention Allocation Allocated to treatment as usual


(n=20) (n=22)
Received allocated intervention Received allocated intervention
(n=20) (n=20)
Did not receive allocated Did not receive allocated intervention
intervention (n=0) - Unable to contact (n=2)

Provided 3 month follow-up (n=17) Follow-Up Provided 3 month follow-up (n=20)


Lost to follow-up Lost to follow-up (n=0)
-Moved (n=1) Discontinued intervention (n=0)
-No response (n=1)
Discontinued intervention
- Illness (n=1)

Provided 6 month follow-up (n=15) Provided 6 month follow-up (n=20)


Lost to follow-up or discontinued Lost to follow-up or discontinued
intervention intervention (n=0)
- No response (n=1)
- Death (n=1)

Analysed (n=20) Analysis Analysed (n=20)


Support Care Cancer (2010) 18:1597–1603 1599

2 months later. Follow-up questionnaires were completed Follow-up questions


3 months (T2) and 6 months (T3) after T1. Control
participants received the workbook after T3 questionnaires Workbook participants completed a short structured evalu-
were completed. There were three and five non- ative feedback telephone interview with LB 1 and 2 months
respondents at 3- and 6-month follow-ups respectively. after receiving the workbook, addressing how useful the
workbook components were, which aspects were helpful,
Intervention and recommended changes.
Treatment fidelity was assessed at T2 using a self-help
The workbook, entitled ‘Women Moving On: A work- compliance measure [12]. Participants rated the percentage
book~journal for women moving forward after treatment of (1) information read, (2) suggestions/exercises complet-
for breast cancer’, was derived in consultation with ed and (3) the average amount of time spent per week using
consumers from a series of focus-groups with survivors the workbook, using three five-point Likert scales. Results
[9]. While some themes were suggested by the previ- were dichotomised into ‘high’ versus ‘low’ levels. Data was
ously evaluated American workbook [8], the current not collected regarding participant utilisation of other
workbook had a different therapeutic basis and content. psychosocial programmes.
Each chapter contained three major components: educa-
tion on common medical and psychosocial issues; sugges- Analyses
tions and worksheets to address the issues; and survivor's
stories and quotes. The chapters address (1) maintaining A repeated measures power analysis was conducted using
the medical partnership, (2) physical well-being, (3) Cohen's f2 moderate effect size coefficient of 0.15. With
feeling alone, (4) family and friends, (5) emotional alpha set at 0.05, and desired power set at 0.80, the required
recovery, (6) spirituality, (7) seeking closure, (8) moving sample size was 65 (33 per condition). Due to slow
forward, (9) living the life you want, and (10) local and recruitment rates a stopping rule was implemented after
national resources. Based on cognitive behaviour therapy 40 women were enrolled, thus resulting in a lack of power
and written emotional expression, the workbook included (0.57).
a relaxation and meditation tape, and was illustrated Analyses were conducted using version 14.0 of the
throughout. The introduction recommended gradually Statistical Package for the Social Sciences. Baseline
reading sections over a 3-month period to reduce partic- differences between groups in demographic, medical and
ipant burden, and to select sections of higher relevance, outcome measures were investigated using t tests or chi-
rather than reading sequentially. square tests of independence. Change between groups
over time was assessed using Linear mixed modelling
Measures [13], which offers the benefit of including participants
with missing data in analyses. This approach allows for
Demographic and illness variables measured were age, direct comparisons between the groups at the 3- and 6-
marital status, education, employment, breast cancer month follow-ups, respectively, by creating a pooled
family history, stage of disease and interventions received baseline mean across groups [14]. Fixed main effects
(surgery, chemotherapy, radiation and hormonal therapy). were treatment-condition (workbook, control), time (3 and
The primary outcome, coping, was assessed using six 6-month) and the covariate (baseline). No adjustments
subscales of the Coping Operations Preference Enquiry were made for multiple comparisons. Within-group effect
[COPE: 10]: planning, restraint coping, seeking social sizes (ES) were calculated, obtaining Cohen's d where
support (instrumental and emotional), turning to religion, 0.20 is considered small, 0.50 moderate and 0.80 large.
and venting emotions. Subscale scores range from 4 to 16, Reliable change indices (RCI) were calculated as an
with higher scores indicating greater endorsement of that indicator of clinical significance according to the method
style. described by Jacobson and Truax [15].
Secondary outcomes, traumatic stress and QOL, were
assessed as follows: PTSD symptoms were measured using
the total scale score of the Posttraumatic Stress Scale-Self Results
Report [10], with scores ranging from 0 to 51. QOL was
assessed using five subscales (global, physical, cognitive, Forty participants were entered into the study (treatment
social and emotional functioning) of the European Organi- n = 20, control n = 20), with an overall mean age of
sation for Research and Treatment of Cancer Quality of 53.05 years (SD=11.44, range 29–79 years). At baseline,
Life Core Questionnaire [11]. Higher scores indicate better groups did not differ on any psychosocial outcome
functioning. measure, demographic or medical variable (Table 1),
1600 Support Care Cancer (2010) 18:1597–1603

Table 1 Summary of demo-


graphic and medical Variable Control Intervention Statistic p
characteristics
Age at study entry 55.64 (11.76) 50.46 (10.77) t(38)=−1.45 0.16
Married/partnered 15 (75%) 16 (80%) χ2(1,N=40)=0.14 0.70
Education level completed
Primary school 3 (15%) 5 (25%)
Secondary 9 (45%) 3 (15%)
Tertiary 8 (40%) 12 (60%) χ2(2,N=40)=4.3 0.12
Employed 9 (45%) 11 (55%) χ2(1,N=40)=0.40 0.53
Family history 6 (30%) 13 (65%) χ2(1,N=40)=5.16 0.05a
Stagea
I 5 (26.3%) 2 (10.5%)
II 14 (73.7%) 17 (89.5%) χ2(1,N=38)=1.58 0.41
Nodes (n with positive nodes)a 10 (52.6%) 16 (84.2%) χ2(1,N=38)=4.39 0.08
Oestrogen receptor positivea 12 (63.2%) 14 (73.7%) χ2(1,N=38)=0.49 0.73
Surgery
Partial mastectomy 10 (50%) 12 (60%)
Total mastectomy 9 (45%) 8 (40%)
a
Analysed 38 participants, one Bilateral total 1 (5%) 0% χ2(2,N=40)=1.24 0.54
missing case per condition Chemotherapya 15 (78.9%) 18 (94.7%) χ2(1,N=38)=2.07 0.34
b
Analysed 39 participants, one Radiationb 16 (80%) 16 (84.2%) χ2(1,N=39) =0.12 0.99
missing case in the intervention Hormonala 11 (57.9%) 13 (68.4%) χ2(1,N=38)=0.45 0.74
group

except women in the workbook condition had a higher Engagement and feedback
frequency of breast cancer family history (65%) compared
to controls (30%). At T2, 88% had read all the information, 81% had
completed 25% or more of the suggestions and exercises,
Repeated measures and 88% spent 1–15 min or more per week using the book.
The dichotomised engagement items did not significantly
No significant group × time interactions were found predict outcomes. Qualitatively, two themes emerged: (1)
(Table 2). A significant fixed effect for group (controlling women said they found the workbook supportive and
for time and baseline) was found for venting coping affirming, preparing them for potential issues, and provid-
[F (1,50.58)=4.74, p=0.034]. Workbook participants had ing strategies to deal with these; and (2) timing; women
higher mean scores at 3- and 6-months than controls. A stated it may have been more relevant and beneficial to
significant fixed effect for time (controlling for group receive at diagnosis and treatment.
and baseline) was found for cognitive functioning
[F (1,35.32) =4.47, p =0.042]. While an improvement
occurred over time for both groups, the ES at 6-months Discussion
showed an improvement of d=0.44 for WB participants
compared to a d=0.03 for controls. In contrast with Angell et al. [8], this pilot study did not
find a strong endorsement for the workbook, as no
Clinical significance interactions were found. However, two trends were
obtained from significant fixed effects and associated effect
A higher percentage of workbook participants experienced sizes. Workbook participants experienced a protective effect
improvements compared to controls across all coping in venting coping, and experienced a benefit compared to
domains, except planning coping (Table 3). Workbook control participants in cognitive functioning. These trends
participants also had a lower percentage of deterioration were supported by the reliable change scores at 6 months,
across all coping domains compared to controls, except where workbook participants experienced more improve-
religious coping. Across secondary outcomes, differences ment and less deterioration in most coping domains
between groups were small, except social function where a compared to controls.
higher percentage of workbook participants experienced The trend of a protective effect on coping was consistent
improvement compared to controls. with conclusions drawn by Angell et al. [8]. However,
Support Care Cancer (2010) 18:1597–1603 1601

Table 2 Mixed model analyses of dependent variables (Time 1 covariate) by time (2) and group (2)

Measure Baseline Workbook Control


covariate valuea
3 month T1–T2 d 6 month T1–T3 d 3 month T1–T2 d 6 month T1–T3 d

Primary outcome
Coping
Planning 8.76 9.32 (0.53) 0.02 8.46 (0.80) 0.18 8.36 (0.49) 0.10 8.51 (0.70) 0.06
Restraint 7.28 7.56 (0.61) 0.02 7.53 (0.78) 0.02 7.67 (0.56) 0.07 6.97 (0.68) 0.13
Instrumentala 8.47 8.41 (0.69) 0.14 8.18 (0.68) 0.23 8.25 (0.64) 0.10 6.80 (0.60) 0.61
Emotional 10.47 9.60 (0.63) 0.40 10.07 (0.57) 0.25 9.42 (0.58) 0.34 8.32 (0.50) 0.71
Religious 7.76 7.30 (0.37) 0.10 7.51 (0.35) 0.02 7.67 (0.34) 0.05 7.32 (0.31) 0.13
Ventingb 7.88 8.03 (0.59) 0.10 8.09 (0.65) 0.05 6.61 (0.54) 0.36 6.71 (0.57) 0.33
Secondary outcomes
PTSDc 10.71 8.74 (1.63) 0.46 9.07 (1.66) 0.42 10.4 (1.50) 0.06 8.55 (1.43) 0.29
QOL
Global 70.60 73.78 (5.98) 0.25 74.55 (6.20) 0.33 73.84 (5.84) 0.17 73.84 (5.95) 0.17
Physical function 84.91 83.06 (2.55) 0.05 85.30 (2.83) 0.33 86.69 (2.36) 0.14 85.02 (2.48) 0.04
Emotional function 70.02 74.28 (3.41) 0.26 69.78 (5.27) 0.07 75.59 (3.15) 0.24 75.17 (4.60) 0.18
Social function 63.43 72.79 (5.62) 0.38 81.12 (4.12) 0.67 80.55 (5.18) 0.62 81.38 (3.67) 0.65
Cognitive functionc 69.91 69.21 (10.97) 0.14 78.14 (11.24) 0.44 67.92 (10.83) 0.10 72.09 (10.99) 0.03

Baseline covariate value=the pooled baseline mean for both groups


The effect of the baseline value of the dependent variable has been statistically removed to allow for direct comparisons across time and group
a
Significant main effect for time, p=0.057
b
Significant main effect for group, p=0.034
c
Significant main effect for time p=0.003
d within-group effect size calculated using raw (not adjusted) mean scores; effect size magnitude: 0.2=small, 0.5=moderate, 0.8=large
T1 baseline, T2 3 month follow-up, T3 6 month follow-up, QOL quality of life

Table 3 Number (N) and per-


centage (%) of participants who Outcome Workbook (n=15) Control (n=20)
experienced a clinically signifi-
cant level of change from base- RCI ↑ N (%)a ↓ N (%)b RCI ↑ N (%) ↓ N (%)
line to 6-month follow-up, based
on reliable change indices, by Primary outcome
group COPE
Planning 2.54 1 (6.7%) 3 (20%) 2.70 5 (25%) 6 (30%)
Restraint 2.40 3 (20%) 2 (13.3%) 2.48 3 (15%) 5 (25%)
Instrumental 3.63 1 (6.7%) 1 (6.7%) 3.67 1 (5%) 7 (35%)
Emotional 2.12 3 (20%) 3 (20%) 3.47 0 (0%) 7 (35%)
Religious 2.39 1 (6.7%) 1 (6.7%) 2.32 0 (0%) 1 (5%)
Venting 2.42 3 (20%) 2 (13.3%) 2.95 2 (10%) 7 (35%)
Secondary outcomes
PTSD 8.30 2 (13.3%) 1 (6.7%) 8.08 2 (10%) 1 (5%)
QOL
Global 25.46 2 (13.3%) 2 (13.3%) 18.68 0 (0%) 1 (5%)
Physical function 24.75 1 (6.7%) 0 (0%) 20.45 1 (5%) 1 (5%)
a
↑ represents clinically significant Emotional function 22.81 2 (13.3%) 2 (13.3%) 25.02 4 (20%) 0 (0%)
improvement in scores Social function 20.60 7 (46.7%) 0 (0%) 34.69 3 (15%) 0 (0%)
b
↓ represents clinically significant Cognitive function 26.06 3 (20%) 1 (6.7%) 31.41 3 (15%) 2 (10%)
worsening in scores
1602 Support Care Cancer (2010) 18:1597–1603

while Angell et al. reported increased emotional venting for To conclude, while trends indicate that a self-help
control participants, the present study reported a decrease. workbook may hold promise in facilitating coping with
As our workbook contained numerous worksheets aimed at breast cancer, firm efficacy conclusions cannot be drawn
facilitating emotional expression, this finding was expected. due to the lack of power and possibility of chance findings.
Previous studies have posited that emotional venting was The feasibility of implementing a self-help resource after
maladaptive [16] as it was theorised to be ruminative and treatment completion could not be not demonstrated with
could thus lead to increased distress over time. However the feedback; instead indicating that the timing for such an
opposite argument has also received empirical support: that intervention needs to be considered. Future research
venting is adaptive, correlating with post-traumatic growth potentially targeting diagnosis and treatment may thus be
[17], and is considered to be a measure of emotional warranted.
expression [18]. This in turn has been demonstrated to
reduce psychological distress [7]. In addition, there could Acknowledgements The authors wish to thank Clinical Trials Nurse
Alison Richards and staff at Flinders Medical Centre Department of
also be cultural differences that may impact whether Medical Oncology for your assistance with recruitment. Thank you
venting is considered adaptive or maladaptive. In summary, also to all the women who participated in this study. This project was
this remains an area of controversy, and it is unclear how supported by the Flinders Medical Centre Foundation ‘Blokes for
venting should be interpreted. Breast Cancer’ grant. Lisa Beatty was supported by an Australian
Postgraduate Award and the Flinders Medical Centre Foundation
A strength of the present study was the inclusion of
Helen Wrigley Award. This trial is registered on the Australian New
QOL as an outcome measure. The finding of impaired Zealand Clinical Trials Registry.
cognitive functioning at baseline and subsequent im- Presented at the 42nd Australian Psychological Society annual
provement in both groups is consistent with a recent conference, Brisbane, Australia, 25–29 September 2007; and the 34th
Clinical Oncology Society of Australia Annual Scientific Meeting,
meta-analysis [19]. The larger effect size for workbook
Adelaide, Australia, November 14–16 2007.
participants may indicate that keeping mentally active
through the workbook activities is beneficial for cognitive Conflict of interest The authors do not have a financial relationship
functioning. with the organisation that sponsored this research. The authors have
full control of all primary data and agree to allow the journal to review
It was unsurprising that workbook engagement failed to
our data if requested.
predict outcomes, given the small sample size. Engagement
was low for completing worksheets, but high for reading
the content; thus future studies need to consider ways to
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