Uptake of the intervention was high. Every woman allocated to the intervention group participated in the face-to-face session and the telephone session. The number of concerns that were raised by woman ranged from 0 to 8, with most woman having 2 to 3 concerns. Together, these observations suggest that there is a high level of need among women with advanced breast cancer that is not currently being met by existing standard health care services. The three most commonly raised issues were concerns about family members, treatment-related issues and fatigue. However, the dominant concerns raised by women varied substantially which demonstrates that a one-size fits all approach to meeting patients' needs is inappropriate. Adult learning occurs most effectively when instruction is focused on issues that are highly relevant to the individual at that time (Knowles, 1989
Overall, the findings did not support the primary hypotheses: there were no significant differences between the two groups in terms of changes in quality of life or unmet needs from baseline. There are a few explanations for the lack of differences. First, perhaps the sample size was not sufficiently large to detect differences between the two groups. A retrospective power calculation suggests that using the sample size obtained, a standardised difference of 0.5 could be detected assuming P<0.05 and power of 70%. However, there was no indication of a trend for any differences in change of quality of life between the two groups. For unmet needs subscales, there were nonsignificant trends for differences between the two groups observed at 1 month, but not 3 months. These trends suggested that there might be a drop in unmet needs in the intervention group but not in the usual care group. However, even if the sample size were increased, would these modest differences represent a clinically significant change?
Second, the uptake of the recommended self-care strategies was only moderate. There appeared to be slightly better uptake of psychological/communication strategies than physical strategies. As uptake of the strategies was essential to the success of the intervention in enhancing quality of life and reducing needs, this is clearly a potentially valid explanation.
Third, despite taking a ‘targeted' approach to the intervention, it may be that the intervention was not sufficiently intense to achieve change. As women's needs vary (Aranda et al, 2005
), it is clear that systematically assessing the most prominent needs and tailoring the intervention specifically to meeting those needs is an important aspect of an effective intervention. More intervention sessions may well have encouraged greater uptake of the strategies, which in turn may have resulted in clinically significant differences between the two groups. Moreover, 56% of woman said that they did not have all their needs met. More sessions may have allowed a greater number of concerns to be addressed. Northouse et al (2005)
came to similar conclusions with their trial of a psycho-educational family intervention program that was also based on the FOCUS framework. However, this may create issues for adoption in routine practice as more sessions would be more resource intensive (Schofield et al, in press
) and patients may not be prepared to attend many more sessions, particularly because fatigue was a major problem (Aranda et al, 2005
There was one important significant effect that indicates that this intervention approach warrants further development. Among woman who expressed high initial psychological needs, those who received the intervention experienced a greater reduction in psychological needs compared with those who did not receive the intervention. This finding reinforces the importance of assessing individual needs and providing this information to the treatment team for intervention, in line with Velikova et al (2004)
earlier work. It also reflects earlier findings (McArdle et al, 1996
) that showed that empathy combined with information reduced psychological distress in women with breast cancer. The approach taken with the current intervention was based on cognitive behaviour techniques, which was found to be successful in previous research (Savard et al, 2005
; Yates et al, 2005
). It involved actively listening, offering empathy and support, helping patients to identify beliefs contributing to their psychological issues and collaborating with patients to select effective strategies, for example: help patients to restructure negative thoughts to positive thoughts.
Overall, quality of life was observed to slightly decrease over the time of the study. This is not surprising among a group of people with advanced cancer. However, there was a tendency for physical functioning to improve by the 3-month follow-up period. This may be because the clinic treatment teams are identifying and controlling the physical symptoms. Indeed, there is evidence that physical symptoms are more likely to be managed than psychosocial ones. In one UK study of cancer patients, concerns about physical symptoms, which the patients generally rated as of ‘low concern', were more frequently addressed by the treatment team than the psychological concerns which patients rated as of ‘high concern' (Hill et al, 2003