THE "NEW" PROSTATE CANCER INFOLINK

The “Reach Out to Enhance Wellness” (RENEW) trial was initiated as a randomized multi-center, multi-national trial to actually prove something which many would consider to be “obvious”: the idea that lifestyle modification will help cancer survivors to avoid the risks that they are at for second malignancies, other comorbidities, and accelerated functional decline. This is an important concept as more and more patients with relatively common forms of cancer (e.g., prostate, colorectal, and breast cancers) now have 5-year survival rates of > 90 percent, and the numbers of cancer survivors are increasing significantly with time.

In order to make sure that the trial was as meaningful as possible, the investigators decided to evaluate the effectiveness of a telephone counseling and direct-mail, print-based diet and exercise intervention in “reorienting functional decline” in older, overweight cancer survivors over a period of 12 months.

The structure of the trial was as follows:

• 641 overweight (body mass index ≥ 25 and < 40), long-term (≥ 5 years) survivors (aged 65-91 years) of prostate, colorectal, and breast cancers were enrolled as participants from Canada, the United Kingdom, and 21 US states between July 1, 2005 and May 17, 2007.
• The participants were randomly assigned to an intervention group (n = 319) or a delayed intervention (control) group (n = 322).
• The active intervention was a 12-month, home-based tailored program of telephone counseling and mailed materials promoting exercise, improved diet quality, and modest weight loss.
• Participants in the control group were “wait-listed” for the initial 12 months of the trial, but were eligible to receive the same intervention after the 12-month wait period.

The primary end point for the study was change in self-reported physical function using the Short-Form 36 physical function subscale (score range, 0-100; a high score indicates better functioning) from baseline to 12 months was the primary end point. Additional measurable outcomes included changes in lower extremity function, physical activity, body mass index, and overall health-related quality of life.

The results of this trial, reported by Morey et al. (on May 13, 2009) in the Journal of the American Medical Association, show that:

• The mean baseline Short-Form 36 physical function score was 75.7.
• After 12-months, the mean Short-Form 36 function scores declined less rapidly in the intervention group (-2.15) compared with the control group (-4.84).
• The mean baseline basic lower extremity function score was 78.2.
• The mean changes in basic lower extremity function were 0.34 in the intervention group compared with -1.89 in the control group.
• Physical activity, dietary behaviors, and overall quality of life increased significantly in the intervention group compared with the control group.
• Weight loss also was also significantly greater in the intervention group (-2.06 kg) compared to the control group (-0.92 kg).

The authors conlude that, “Among older, long-term survivors of colorectal, breast, and prostate cancer, a diet and exercise intervention reduced the rate of self-reported functional decline compared with no intervention.”

One might be tempted to think that the changes in Short-Form score and other end points in this trial are relatively small (e.g., decline in overall mean functional score of 2.8 percent for the intervention group compared to 6.4 percent in the control group). However, it is clear that the overall effects of the program seem to be highly significant, since one has to assume that all of the participants in this trial were sufficiently motivated to enter the trial in the first place, and that they were all therefore making at least some attempt to maintain a reasonable quality of life.

The abstract offers no information about the costs of managing this program. However, given the costs of hospitalization and even home care for those who are unable to care for themselves, it seems highly likely that this program only needed to keep a small number of patients out of hospital and able to care for themselves over time in order for the initiative to be cost-effective.

Filed under: Living with Prostate Cancer, Management | Tagged: lifestyle, quality of life, survival |