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Participants randomised to the Intervention group will be referred to an expert assessment of their shoulder impairments at the Shoulder Sector, Vejle Hospital - Orthopaedic Department. The expert assessment will be performed by experienced specialists (e.g. physician and physiotherapist) who are specialised in shoulder diagnostics using x-ray, ultrasound, anamnesis/history and standard clinical tests such as Neers, Hawkins, Jobe´s Empty Can, Painful Arc and Resisted External Rotation. The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan. The individualised treatment plan will typically contain a referral to physiotherapeutic treatment at the municipality or private practice, receive specialised physiotherapeutic rehabilitation at Vejle Hospital, get an ultrasound guided corticosteroid injection in the shoulder or offer surgery.

Participants randomised to the Control comparator group will receive a pamphlet from the secretary and perform the exercises at home. This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment. The purpose is to stimulate circulation, improve shoulder function (mobility), increase muscle strength and reduce shoulder pain. The program consists of three warm-up exercises (arm swing, shoulder rolling and scapula-back pocket exercise) followed by three stretching exercises for the breast and shoulder area. Furthermore the pamphlet includes a tissue treatment and four strength exercises for the shoulder (external rotation, extension and flexion of the shoulder and diagonal pull apart). Mobility (with 5-10 repetitions), stretching exercises (in 30 seconds) and tissue treatments will be performed twice a day, while the strength exercises will be performed once a day with 3x12 repetitions.

The participant's diagnosis based on the history, symptoms and clinical findings will be used to guide the individualised treatment plan.

The expert assessment of shoulder impairments and individualised treatment plan

This pamphlet contains a program with minimal exercise recommendations for the shoulder consisting of mobility, stretching, strength exercises and tissue treatment.

A minimal physiotherapeutic rehabilitation program delivered in a pamphlet

Kim Gordon Ingwersen, PT, PhD

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.

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.

An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.

Effectiveness of an Expert Assessment and Individualised Treatment in Comparison to a Minimal Home-based Exercise Program in Women With Late-term Shoulder Impairments After Primary Breast Cancer Surgery.

Personal data for the primary and all secondary outcome measures will only be made available if required by the scientific journal, in which the result of the trial are published.

Pain medication consumption in the past week due to shoulder related pain including questions about yes/no, type (prescription or nonprescription medicine) and frequency will be collected by using a patient-reported questionnaire.

PHQ-9 is a 9-item patient-reported outcome measure to assess depression within the last 2 weeks. The total score ranges from 0 to 27; 5-9 = minimal symptoms, 10-14 = minor/mild depression, 15-19 = major depression, moderately severe, \>20 = major depression, severe. The higher the score, patients report severe depression and reduction in the PHQ-9 score will suggest improvement. PHQ-9 is a reliable and valid measure of depression in cancer patients and the general population and can measure changes over time.

GAD-7 is a 7-item patient-reported outcome measure to assess anxiety within the last 2 weeks. The total score ranges from 0 to 21; 0-4 = minimal anxiety symptoms, 5-9 = mild anxiety symptoms, 10-14 = moderate anxiety symptoms, \>15 severe levels of anxiety symptoms. The higher the score, patients report severe anxiety and reduction in the GAD-7 score will suggest improvement. GAD-7 is a reliable and valid measure of anxiety in cancer patients and the general population.

SPADI is a 13-item patient-reported outcome measure to assess shoulder pain (5 items) and shoulder function (8 items) within the last week. The items are scored on a numeric rating scale that ranges from 0 (no pain/no difficulty) to 10 (worst pain/so difficult that required help). Each domain score is equally weighted and added to a total percentage score that ranges from 0 (best) to 100 (worst). The higher the score, patients reported shoulder impairments. The region specific questionnaire can be used in patients with different or unspecified shoulder diagnoses. SPADI is valid, reliable and responsible measure among patients with shoulder impairments.

Change in SPADI pain will be reported as a separate subscale. The 5-item pain subscale are scored on a numeric rating scale that ranges from 0 (no pain) to 10 (worst pain). The higher the score, patients report greater shoulder pain and reduction in the SPADI pain score will suggest improvement.

Change in SPADI function will be reported as a separate subscale. A 6-item version (exclusion of question three and seven) of the disability subscale exhibited adequate fit in the Danish version. The 6-item disability subscale are scored on a numeric rating scale that ranges from 0 (no difficulty) to 10 (so difficult that required help). The higher the score, patients report greater shoulder disabilities and reduction in the SPADI function score will suggest improvement.

Response to treatment will be computed for the SPADI change score for each woman in both treatment groups and presented dichotomised (i.e. responder and non-responder) as number (and percentages) responders. Women will be classified as an responder if the SPADI change score improves by 8 points or more (≥), corresponding to the minimal clinically important difference on SPADI from baseline to 12 weeks follow-up.

The GPE will evaluate the impression of the treatment's success including overall shoulder problems on a 7-point Likert scale ranging from "markedly worse" to "markedly improved".

A smartphone inclinometer (GetMyROM) will be used to assess A-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.

A smartphone inclinometer (GetMyROM) will be used to assess P-ROM in flexion, internal rotation, external rotation and abduction respectively the operated side. After one test trial, the mean value of three measurements will be taken for both flexion, rotation and abduction respectively the operated side.

Number of visits to a healthcare professional (e.g. physician, chiropractor or physiotherapist) at hospital, municipality rehabilitation or private practice due to the shoulder symptoms during the intervention period, will be collected by using a patient-reported questionnaire.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess the maximum shoulder pain intensity. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain intensity and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during general activities. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain at rest. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during sleep. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

The NRS pain scale is a single 11-item patient reported outcome measure used to assess pain during flexion/rotation/abduction. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). The higher the score, patients report greater shoulder pain and reduction in the NRS score will suggest improvement. The NRS is a reliable, valid and responsive measure of pain in patients with cancer.

Spots Global Cancer Trial Database for a minimal physiotherapeutic rehabilitation program delivered in a pamphlet