Clinical trial NCT05277909: An Individualised Treatment vs. a Minimal Program in Women With Late-term Shoulder Impairments After Breast Cancer.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Late Effect
Breast Cancer
Rehabilitation
Keywords: Shoulder Impairments
Late Term
Breast Cancer
Rehabilitation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2022-03-14
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Breast cancer patients who underwent unilateral BCS or mastectomy on the left or right side, including SLND or +/- ALND within the last 3-7 years (2015-2019)
2. Currently living in the Region of Southern Denmark or Central Denmark Region with a radius of 75 km from Vejle Hospital
3. Between 18 and 71 age on time of surgery for primary breast cancer
4. Indicate pain in chest and/or shoulder area (shoulder impairments) as the biggest problem/late-term effect in everyday life
5. Indicate impaired shoulder function due to pain or due to tightness/tension
6. Indicate shoulder pain at rest, during general activities, during sleep or during flexion, rotation or abduction of the shoulder
7. A score ≥15 on the Disabilities of the Arm, Shoulder and Hand (Quick DASH)
8. Agree to participate in this trial and signs written informed consent

Exclusion Criteria:

1. No previous breast cancer (before 2014)
2. Cancer relapse after the date of index surgery, cancer spread outside of thorax and axilla, tumor fixed to chest wall
3. Primary- or secondary breast reconstruction performed at any time
4. Severe lymphedema (an average score ≥ 70% in the first 7 questionnaires on the LYMPH-ICF-DK
5. Bilateral breast cancer surgery
6. Previous surgery in the affected shoulder (prior to inclusion)
7. Previous shoulder or upper limb fractures (left/right)
8. Currently receiving chemo, immuno- or radiotherapy
9. Co-morbidity expected to influence shoulder function (e.g. rheumatoid arthritis, previous stroke, multiple sclerosis)
10. Other reasons for exclusion (e.g. pregnancy, not legally competent, unable to comprehend the information or unable to consent)

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
Secondary outcomes:
measure: Change in SPADI pain from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in SPADI function from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: SPADI clinical response.
timeFrame: 12 weeks (follow-up)
measure: Global Perceived Effect (GPE) measured at 4, 8 and 12 weeks after initiating the treatment.
timeFrame: 4, 8 and 12 weeks
measure: Change in Active Range Of Motion (A-ROM) in the affected shoulder from baseline to 12 weeks after initiating the treatment.
timeFrame: 0 and 12 weeks
measure: Change in Passive Range Of Motion (P-ROM) in the affected shoulder from baseline to 12 weeks after initiating the treatment.
timeFrame: 0 and 12 weeks
measure: Number of treatments received due to shoulder symptoms from baseline to 12 weeks after initiating the treatment.
timeFrame: 12 weeks (follow up)
measure: Change in maximum shoulder pain intensity within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in shoulder pain during general activities within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in shoulder pain at rest within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in shoulder pain during sleep within the previous 24 hours in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in shoulder pain assessment during flexion/rotation/abduction in the affected shoulder measured by Numeric Rating Scale (NRS) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0 and 12 weeks
Other outcomes:
measure: Change in pain medication consumption from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in Patient Health Questionnaire - 9 (PHQ-9) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
measure: Change in General Anxiety Disorder - 7 (GAD-7) from baseline to 12 weeks after initiating the treatment.
timeFrame: 0, 4, 8 and 12 weeks
Locations:
city: Vejle
country: Denmark
facility: Department of Physio- and Occupational Therapy, Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Kim Gordon Ingwersen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feder KM, Rahr HB, Lautrup MD, Egebaek HK, Christensen R, Ingwersen KG. 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. Trials. 2022 Aug 20;23(1):701. doi: 10.1186/s13063-022-06659-1.