A randomised controlled trial to evaluate the effects of a self-help workbook intervention on distress, coping and quality of life after breast cancer diagnosis

Although breast cancer survival rates are improving,1 a diagnosis of breast cancer elicits greater distress than other medical diagnoses.2 Depression, anxiety, and posttraumatic stress occur in up to 66% of women in the first year following diagnosis,3,4 with quality of life (QOL) being similarly globally adversely affected over this period.5-7 Maladaptive coping has been shown to predict distress and impaired QOL, and particularly emotional repression, cognitive and behavioural avoidance and helplessness/hopelessness.8-9 While group interventions are demonstrably effective in improving outcomes,10 only a fifth of Australian women participate in such interventions.11 Group programs are generally run during working hours in urban treatment centres, thus rural patients and full-time workers are often unable to attend. Other reasons for non-attendance include: (i) not feeling comfortable in a group setting; (ii) not wanting to hear other women’s problems; and (iii) preferring to manage problems alone.11 In contrast to “information alone” resources, which research shows are insufficient for changing behaviour or attitude,12 innovative interventions are required that are interactive but can be completed by the individual.

Self-help interventions can provide solutions to attendance barriers, while providing the interactive benefit. A self-help workbook for 100 women either recently diagnosed or recently completing treatment was designed and then evaluated by Ansell and colleagues in a randomised controlled trial.13 After 3 months, control participants who had completed treatment experienced significantly increased posttraumatic stress symptoms and venting, and decreased fighting spirit compared with workbook participants who reported stable levels. Women closer to diagnosis did not benefit from the workbook, leading the authors to conclude that treatment completion was a more appropriate time to use this resource.13 This conclusion contrasts with meta-analytic reviews which have found that targeting closer to diagnosis is more effective.10 Thus, in this study, we examined whether an Australian self-help workbook could be efficacious in women recently diagnosed with breast cancer. We hypothesised that workbook participants would show greater reductions than controls in the primary outcome, distress, and greater improvements in the secondary outcomes, QOL and coping.

Participants were women with Stage 0 to II breast cancer diagnosed in the previous month, who spoke English, were aged 18 years or over, and had no pre-existing neurological conditions. Participants were recruited from 1 February 2007 to 1 February 2008, in two public hospitals located in urban settings and serving a range of socioeconomic groups. While one hospital served a large geographical region, including rural patients, the other served a high proportion of culturally and linguistically diverse patients. The trial obtained ethics approval from the Flinders Clinical Research Ethics Committee, and is registered with the Australian New Zealand Clinical Trials Registry.

Procedural elements of this study conformed as closely as possible to the 2010 CONSORT (Consolidated Standards of Reporting Trials) statement,14 and no changes were made to the methods after trial commencement. Block random allocation was used (implemented through the use of numbered containers) and the sequence was concealed until interventions were assigned. Box 1 illustrates the flow of participants through the study. Women were informed of the study by a breast-care nurse, and those interested in participating were contacted by a researcher (L J B).

After completing baseline questionnaires, participants were allocated to the intervention or control group and informed of their treatment status on receiving the workbook (treatment intervention) or an information booklet (control condition). Follow-up questionnaires were completed 3 and 6 months later. Non-respondents numbered four at 3 months follow-up and zero at 6 months follow-up.

Of the 80 women who met inclusion criteria, 49 (61%) consented to participate (25 in the intervention group, 24 in the control group). The overall mean age was 55.2 years (SD, 12.7; range, 32–86). There were no differences between groups at baseline (Box 2). The median amount of information read by women in the workbook group was 100%, compared with 75% for those in the control group. Women in both groups used their intervention for up to 15 minutes each week. Participants in the workbook group completed a median of 25% of worksheets.

Current findings indicate that a self-help workbook can be an effective resource for women recently diagnosed with breast cancer, and particularly for those with higher baseline distress, but that modifications need to be made to the body image module. At 3 months, participants in the workbook group had greater reductions in posttraumatic stress, cognitive avoidance, and helplessness/hopelessness compared with those in the control group. While no longer significant at 6 months, the benefits obtained by workbook participants in posttraumatic stress and helplessness/hopelessness were maintained, and the loss of significance was the result of control group participants making later improvements. Workbook group participants returned to baseline levels of cognitive avoidance at 6 months, but did not experience the deterioration reported by control group participants. Thus, it is clear that the workbook was effective in the short term while women actively used it, helping them to decrease distress more quickly. Further support was obtained from the finding that those with high baseline distress received superior benefit from the workbook compared with those with low distress, consistent with previous group intervention research.10,22 These favourable results must be balanced against the significantly greater reductions in body image experienced by participants in the workbook group compared with those in the control group at both follow-ups, and the lack of impact that the workbook had on anxiety and depression. The most substantial clinically significant change supported the beneficial impact of the workbook on symptoms of posttraumatic stress and the detrimental impact on body image.

The posttraumatic stress and coping benefits obtained in our study generally support previous research,17 but two important differences emerged. First, in the previous study, the workbook was not effective in women who had recently been diagnosed, while the present study obtained significant interactions for this population. Second, Angell and colleagues found their workbook prevented the increase in posttraumatic stress symptoms which occurred in control participants,13 while the workbook in our study actually reduced symptoms.

Our finding of impaired body image in participants in the workbook group was surprising and contrary to our hypothesis. One potential explanation relates to the mirror desensitisation worksheets in the workbook, which asked women to develop an exposure hierarchy to different body parts and then systematically view these body parts using a mirror until the anxiety response resolved. One recent review of treatments for body image disturbance reported mixed evidence for the utitlity of mirror desensitisation.23 Numerous sessions are required for benefits to be obtained, and might result in deteriorations in mood and self-esteem in the short term.23 Thus, these worksheets may have sensitised women to an issue they had been previously unaware of, during a potentially vulnerable time (during chemotherapy). Given that sub-analyses demonstrated that women in the workbook group who were not distressed about body image at baseline experienced deteriorations, self-help may not be an appropriate method for addressing body image. Clearly, information can be provided (as both groups received this), but women who wish to address body image should be referred to alternative resources.

This study had three methodological strengths. First, it adhered rigorously to the 2010 CONSORT statement for the reporting of randomised trials.14 Second, it included a 6-month follow-up assessment, to further delineate the impact of the workbook. If only 3-month data had been gathered, the workbook would have appeared more efficacious than it really was. Third, the control group was exposed to information alone, rather than receiving no intervention. Given the evidence that suggests that receiving information alone is not enough to effect change,12 providing information to the control group is considered a better test of the strength of the intervention condition than just treatment as usual. However, one limitation of our study — small sample size — means that our results must be interpreted cautiously and that further studies are required before firm conclusions can be drawn.

Future research might valuably compare the self-help workbook with existing group interventions to compare benefits and cost-effectiveness. Alternative methods for delivering self-help also warrant exploration, in particular, via the internet, as this has demonstrated efficacy in other populations and further increases accessibility.24 Overall, our study provided preliminary support that a self-help workbook can beneficially impact on posttraumatic stress, cognitive avoidance and helplessness/hopelessness in women currently undergoing treatment for breast cancer.

1 Flow diagram of participant recruitment and involvement in the randomised trial of a workbook intervention for primary breast cancer patients