Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation

Abstract

Objective To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Design Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. Setting 17 UK National Health Service cancer centres. Participants 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Interventions Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Main outcome measures Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Results Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) −2.02, −3.11 to −0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average −£387 (€457; $533) (95% confidence interval −£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. Conclusions The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. Trial registration ISRCTN Registry ISRCTN35358984 .

Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery: study protocol for a randomised controlled trial

“…We applied the following pragmatic search terms to identify studies; searched on 8 August 2022: {Exercise[tiab] AND shoulder[ti] AND (impairment [tiab] OR pain [tiab]) AND (("breast cancer" OR breast) AND cancer)}. We found 19 records in database searching, from which 8 records corresponded to randomised trials [28,[33][34][35][36][37][38][39]. Thus, the result of the present randomised trial is expected to have a high impact in the health system to in terms of having more focus on late-term shoulder impairments and improving the quality of physiotherapeutic rehabilitation, especially for physiotherapists involved in the management of breast cancer and late-term shoulder impairments.…”

“…Previous international research has primarily focused on prevention and treatment of lymphoedema, and less on other upper limb impairments [9,15,18,20,26,27]. Preoperative and early postoperative physiotherapeutic interventions are known to be effective in reducing shoulder pain and improving shoulder function after breast cancer treatment [9,[28][29][30], but there is a lack of international knowledge on the effectiveness of these interventions on the late-term sequelae. The importance of more focus on this is emphasised by studies of a prevalence of up to 50% of impaired shoulder function and pain up to 6 years after surgery [9,11,19,20,23,27].…”

Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT

“…FIGURE 2 The CONSORT flow diagram of trial participants. Adapted with permission from Bruce et al102 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/.…”

“…102 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/ licenses/by/4.0/.…”

“…DASH scores by treatment group and time period: ITT analysis Adjusted for age, baseline DASH score, type of breast surgery, axillary surgery, radiotherapy and chemotherapy. Adapted with permission from Bruce et al102 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/.TABLE 13 Comparison of primary outcome by ITT and CACE analysis at 12 months…”