LAS GARANTÍAS DE LA PROTECCIÓN

Title: Economic Evaluation Alongside a Clinical Trial of Psycho-Educational Interventions to Improve Adjustment to Survivorship Among Patients With Breast Cancer

Aims: To collect data alongside a randomised trial to comparethe costs and benefits of three

psycho-educational strategiesto improve transition to cancer survivorship.

Title: Economic evaluation alongside a clinical trial of psycho-educational interventions to improve adjustment to survivorship among patients with breast cancer.

Aims: To collect data alongside a randomised trial to comparethe costs and benefits of three

psycho-educational strategiesto improve transition to cancer survivorship.

Participants: Women wereeligible if they had received surgery for invasive breast cancerof any size or nodal status. Exclusion criteria included useof neoadjuvant chemotherapy, high- dose chemotherapy with bone marrow or stem-cell rescue or protracted reconstructive surgery,and inability to read and write in English. Exactly 418 women completed the original trial; 396 women returned calendar data; 389 women were available for the economic analyses.

Outcomes: The outcomes for this analysis were changes in distress andenergy 6 months

post-intervention, as measured by the RevisedImpact of Events Scale (IES-R) and the SF-36 vitality scale, respectively. The vitalityscale captures energy level and fatigue. Because of skewness in the IES-R score distribution, a logarithmic transformation was performed to produce a relatively normal distribution ofIES scores; the scores were retransformed for cost- effectiveness analysis. Higher change scores for the SF-36 represent more energyand a higher IES change score represents less distress pre-to post-intervention. There were some baseline imbalances in the study arms, so baseline depression was controlled for in calculating outcomes. Costs stratified bybaseline level of preparedness for transition were also calculated. Preparednesswas defined by responses to two items ("Overall, I feel very well prepared about what to expect during recovery; Overall,I feel the medical team has done a great deal to prepared mefor what to expect during my recovery."). Overall 12-month health care costs were assessed bystudy arm.

Methods: Women completed a baseline survey 4 to 6 weeks after primarytreatment; the survey was repeated at 6 and 12 months after the intervention. The research staff used weekly logs to record the time and resources used to deliver the interventions. Finally, participants were mailed calendars every 3 months to document all health services used; those notreturning calendars were provided mail and telephone reminders. Three strategies for improving survivorship transitions were compared. The least expensive approach (a booklet control condition) wascompared with the next most expensive (an educational video plus the control booklet); the video was compared incrementallyto the most expensive option (counselling plus the video plusthe booklet). Women randomly assigned to the control arm were maileda copy of the 1994 National Cancer Institute publication FacingForward.Women assigned to the educational videotape arm alsoreceived the booklet and a videotape entitled, "Moving beyondCancer." This 23-minute film was designed to address re-entrychallenges in physical health, emotional well-being, interpersonalrelations, and life perspectives. The video includes peer modelling of active coping approaches to fatigue and other survivorship concerns. The last arm included psycho-educational counselling(one individually conducted in-person session and one telephonesession) plus the video and booklet.

Randomisation: Women were randomised to one of three conditions: a booklet control

group; educational video plus the control booklet; and counselling plus video plus control booklet.

65

Response Rates: Exactly 418 women (74.9%) completed the original trial; 396 women

(94.7%) returned calendar data. Seven women were missingtreatment or other information, leaving 389 women (69.7%) for economic analyses. There were no significant differences betweenthose completing economic data and those not doing so.

Results: The costs of the control, video, and video plus counselling arms were $11.30,

$25.85, and $134.47 per person, respectively. Thevideo costs were $2.22 per unit increase in energy comparedwith control; among women who were the least prepared for transition,the video was more effective, resulting in even lower costs. The video cost $7,275 per unit change in distress versus control, but costs were lower in the subgroup least prepared for transition($355). The counselling arm was more expensive and less effectivethan the video for virtually all end points. However, in one group, women more prepared for transition, counselling cost $1,066per unit decrease in distress compared with the video. Health care costs tended to increase as intervention intensity increased.

Conclusion: In this trial, the educationalvideo was the most cost-effective way to improve

transitionto survivorship. It will be important to confirm whether thereis an increased use of services after such interventions andif this represents appropriate use of rehabilitative and supportivecare or over-use.

Strengths and Limitations: The patients included in this trial had high education and

income. It is possible that less advantaged women might be more vulnerable to poor adaptationand might benefit more from intervention or require differentor more costly types of interventions. The study was limited tovolunteers for a randomised controlled trial in three geographicregions and may not be generalisable to all breast cancer survivors. The study arms were unbalancedfor baseline depression and although depression was controlled for,it is possible that there are residual unmeasured differencesbetween the groups. Although the videoproduced benefits at the lowest costs, this benefit was for a defined, limited period of time: the 6 months after active treatment ended. The video tended to produce continued positiveeffects at 12 months, but this trend was not statistically significant. The findings are further limited by self-report of health care use. However, the use of randomisation and validated outcome measures adds strength to results.

66