Kwiatkowski, F., Mouret-Reynier, M.A., Duclos, M., Leger-Enreille, A., Bridon, F., Hahn, T., . . . Bignon, Y.J. (2013). Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. European Journal of Cancer, 49(7), 1530–1538.doi: 10.1016/j.ejca.2012.12.021
Determine the effectiveness of an intensive intervention (i.e., two weeks at a SPA centre involving exercise, physiotherapy, and dietary education) on overall quality of life, weight, nutrition, and physical activity in women who recently had completed treatment for non-metastatic breast cancer
The intervention included a two-week stay at a SPA centre with a daily routine of physical training (i.e., two hours daily under the supervision of a physiotherapist, which included walking, strength training, and aquaexercise), dietary education with cooking lessons and provision of healthy meals, and aesthetic care, massage, etc. Dietary consultations every six months for three years also were incorporated into standard follow-up care.
PHASE OF CARE: Transition phase after active treatment
Prospective, randomized, repeated measures (baseline, 6, 12, 18, and 24 months after intervention) two-group clinical trial
Statistically significant differences were seen between groups on the SF-36 measure at six months, but these differences did not persist in any dimension at year one except for a difference in vitality at one year between groups. Although data were collected on weight/body mass index, diet, and sleep, results for these variables are not reported (except to note no significant differences in sleep between the groups). The plots/trends in quality of life over time (at 6, 12, 18, and 24 months) look very similar for both groups, except for a significant upward trend at six months for the intervention group. The correlation was stronger between HADS depression and SF-36 quality of life. In the SPA group, an overall decrease was seen in anxiety compared to baseline scores (p = 0.0005). No significant difference was seen in the anxiety scores between the SPA and control groups at six months. Depression decreased in both groups but to a greater degree in the SPA group. A significant difference was seen between the SPA group and control group in terms of depression scores. What the “control” or comparison group was or what care was given to them is not clear.
As reported, patients with non-metastatic breast cancer did not appear to derive significant benefit (improved quality of life as measured by the SF-36) from a two-week SPA intervention in terms of improving quality of life and reducing anxiety and depression.
This unrealistic intervention (two-week SPA stay) does not seem sustainable. Furthermore, if this “intensive” intervention did not demonstrate significant impact on quality of life or anxiety, except for depression, then the “cost” of such an intensive intervention is not worth the benefit. When exactly the intervention occurred is not reported relative to timing of completion of breast cancer treatment except to say “within nine months,” but this is an important variable/covariate because time since treatment completion (and intervention) might impact study results. Importantly, unclear is how subjects were screened or that only a “distressed” group was enrolled. The report that global SF-36 scores at study inclusion were 56 and 54 respectively (treatment and control groups) indicates that this is not a very “stressed” group, as evidenced by SF-36. The higher the scores on the SF-36, the better the quality of life. These scores at study inclusion are right at the midpoint range of 0%–100%; thus, a possible floor effect is at play. Overall, this is not a very well developed or reported study.
No real meaningful nursing implications are drawn from this study. The intervention seems unrealistic and unsustainable and did not impact outcome measures as predicted, except for depression.