Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial

Abstract

BackgroundFatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave.Methods/DesignThe Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term) and after 9 months (long term). Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List) and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey), impact on functioning and autonomy (Impact on functioning and autonomy questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), physical fitness (aerobic peak capacity, muscle strength), body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level will be measured using the Short Questionnaire to Assess Health-Enhancing Physical Activity and will be monitored with an exercise log and a pedometer.DiscussionThis study investigates the (cost)-effectiveness of exercise during adjuvant treatment of patients with breast or colon cancer. If early physical exercise proves to be (cost) effective, establishing standardised physical exercise programmes during cancer treatment will be planned.Trial registrationCurrent Controlled trials ISRCTN43801571, Dutch Trial Register NTR2138

Conservative handling of missing information

“…Indeed, our study found a relatively high percentage of trials with unclear blinding status, varying between 48.5% (for blinding of patients) and 84.1% (for blinding of data analysts) [1]. At the same time, it has been previously documented, and confirmed in our study, that a substantive percentage of trials not reporting the blinding status of those involved had actually blinded them [2].…”

“…As noted by Berger [2], ''in most cases the parties with the most vested interests in the outcomes are the very ones conducting the studies, and enjoying the discretion to sway the results one way or another. The last thing we want, from a scientific perspective, is to provide incentives to these experimenters to 'accidentally' lose some key data.''…”

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization

“…We will discuss several alternatives using the PACT study as an example [1]. The PACT study is a multicenter randomized controlled trial (RCT) that studies the (cost) effectiveness of exercise during cancer treatment.…”

“…Participants who were allocated to the control group were recommended to be physically active for at least 30 minutes a day, 5 days a week according to the Dutch guideline for physical activity [14], which is based on international recommendations [15,16]. During the pilot study, 64 patients were included (September 2008eDecember 2009) [1]. The proposed Zelen design could have been effective if patients had not had the chance to meet each other.…”

Efectividad del ejercicio físico en la fatiga de pacientes con cáncer durante el tratamiento activo: revisión sistemática y metaanálisis

“…Estos resultados coinciden con lo descrito por Velthuis et al 41 , quienes observaron que una intervención con entrenamiento de resistencia durante 18 semanas reducía de manera significativa los niveles de fatiga en pacientes con cáncer de mama y cáncer de colon en fase de tratamiento activo. De manera similar, Winters-Stone et al 42 concluyen que el entrenamiento de resistencia no sólo reduce la fatiga en pacientes oncológi-cos, sino que además disminuye la posibilidad de sufrir caídas accidentales en estos pacientes.…”