An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.
Condition: Shoulder Pain; Late Effect; Breast Cancer; Rehabilitation
MeSH terms: Breast Neoplasms; Shoulder Pain
Study type: Interventional

Summary: 
      In breast cancer patients late-term upper limb sequelae, such as shoulder pain and impaired
      shoulder function remain common after primary breast cancer surgery. The aim of this trial is
      to evaluate whether an expert assessment of shoulder impairments, followed by an
      individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation
      program in reducing shoulder symptoms, assessed 12 weeks after initiation of treatment, among
      women with late-term shoulder impairments after primary breast cancer surgery.
    

Detailed description: 
      Worldwide, breast cancer is the second most common cancer. Internationally, an
      age-standardised incidence rate between 83.1 and 111.9 per 100.000 women is seen, with
      Denmark taking an unfortunate second place. Standard surgical treatment in Denmark is
      breast-conserving surgery (BCS) or mastectomy in combination with sentinel lymph node
      dissection (SLND) or axillary lymph node dissection (ALND). In part due to early diagnosis
      and optimised treatment methods, 5-year survival has improved to a current 87%. Despite fewer
      mastectomies and more BCS, less invasive surgical procedures of the axilla (e.g. fewer ALND
      vs. SLND), and more refined radiotherapy procedures, late-term upper limb impairment still
      remains common. The most frequent are lymphoedema, sensory disturbances, pain and impaired
      shoulder function, with up to 70% of patients reporting at least one of these symptoms three
      years after surgery. These impairments lead to difficulties in activities of daily living,
      increased risk of depression and anxiety and decreased quality of life (QoL).

      Previous research has primarily focused on prevention and treatment of lymphedema, and less
      on other upper limb impairments. Pre- and early postoperative physiotherapeutic interventions
      are known to be effective in reducing shoulder pain and improving shoulder function after
      breast cancer treatment. Nonetheless, late-term upper limb impairments need further focus
      with prevalence´s of up to 50% is reported for impaired shoulder function and pain up to 6
      years after surgery, and a substantial knowledge gap exists as to how to help these women.
      Currently, no standardised evaluation of their impairments or treatment is offered, and it is
      therefore up to the individual woman to seek care, resulting in large variations in
      rehabilitation. Thus a substantial knowledge gap exists in how to meet the rehabilitation
      needs of these women and evaluation of the actual burden of late-term shoulder impairments
      after primary treatment for breast cancer and the effect of different treatment strategies is
      warranted.

      The primary aim of this study is to investigate whether the effect of a patient-centred
      specialised intervention, consisting of an expert assessment followed by an individualised
      treatment plan (i.e. Intervention group), is superior to a minimal physiotherapeutic
      rehabilitation program delivered in a pamphlet (i.e. Control comparator group) among women
      with late-term shoulder impairments 3-7 years after their primary breast cancer surgery. The
      hypothesis is that women randomised to the Intervention Group will improve significantly more
      in shoulder function and pain 12 weeks after initiating the treatment than those randomised
      to the Control comparator group.

      This trial is a stratified (by type of surgery and radiotherapy), block randomised (1:1
      allocation), controlled, parallel group and assessor blinded superiority trial conducted in
      Denmark. 130 participants with late-term shoulder impairments 3-7 years after primary surgery
      for breast cancer will be recruited.
    

Intervention name(s): The expert assessment of shoulder impairments and individualised treatment plan; A minimal physiotherapeutic rehabilitation program delivered in a pamphlet
Intervention type(s): Other; Other
Intervention description(s): The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan.; This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder Impairments; Late Term; Breast Cancer; Rehabilitation