Rationale

• Breast cancer treatments can affect the shoulder and upper body, resulting in limited range of motion, weakness, persistent pain and lymphoedema.
• These symptoms can sometimes last for years after treatment.
• Structured exercise programmes, commenced within days or weeks of surgery, can improve shoulder movement and reduce complications.
• Usual NHS care is to provide information leaflets recommending upper body movements after breast cancer surgery to all women.

Aim

The PROSPER trial aims to prevent shoulder problems in women treated for breast cancer. The trial will investigate the clinical and cost-effectiveness of early supervised exercise compared to usual care, on outcomes of shoulder/arm function, health-related quality of life, chronic pain and other postoperative complications, following treatment for breast cancer.

Trial Design

A multi-centre, pragmatic randomised controlled trial of usual care (written information leaflets) versus an individualised physiotherapist-led exercise and information programme.

Randomisation between the two arms will be stratified by surgery (first, repeat), centre, and whether the patient was informed of a need for radiotherapy within 6 weeks of having their surgery.

PROSPER aims to recruit 350 patients from approximately 15 NHS Breast Cancer Centres.

Outcome Measures

Primary outcome:

• Arm function measured using the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire at 12 months

Secondary outcomes:

• Arm, shoulder and hand function DASH subscores at baseline, 6 months and 12 months;
• Health-related qualitfy of life measured using SF-12 and EQ-5D-5L at baseline, 6 months and 12 months;
• Postoperative adverse events, including; surgical site infection (SSI) at 6 weeks (clinical and patient reported criteria); acute and chronic postoperative pain at 6 weeks, 6 months and 12 months (DASH pain scale, DN4); lymphoedema symptoms (PROSPER specific items);

• Healthcare resource use at 6 months and 12 months