Effect of lymphadenectomy on limb function and health related outcomes
Research type
Research Study
Full title
The effect of lymphadenectomy on limb function and health related outcomes- to determine whether early identification of psychological, physical and support issues improve patient quality of life and unmet needs.
IRAS ID
200856
Contact name
Jennnifer Garioch
Contact email
Sponsor organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 6 days
Research summary
Summary of Research
There is a lack of quality of life data in the literature specific to melanoma and nodal dissection patients. The aims of this study is to assess whether targeted supportive interventions delivered by a multi-disciplinary team in a specifically designed pre and post operative clinic for this cohort of patients will improve the quality of life and improve patient-reported outcome measures (PROMS) in those undergoing radical lymph node dissections (neck, axilla and groin) for metastatic melanoma. (Stage III).Summary of Results
Effect of lymphadenectomy on limb function and health related outcomesThis pilot study was carried out at the Norfolk and Norwich University Hospital in collaboration with the dermatology and plastic surgery team. The chief investigator is a consultant dermatologist supported by a dermatology nurse consultant as principle investigator.
Patients who met the criteria for this study were identified at the skin cancer multidisciplinary team weekly meetings with subsequent recruitment. No funding was required for this study, there are no identified competing interests. The study is sponsored by Norfolk and Norwich University Hospitals NHS Foundation - research governance committee.
The study commenced on 13/07/2016 with recruited patients seen across both the dermatology and plastic surgery outpatient departments.
The study was identified as a prospective longitudinal cohort study of melanoma patients who had undergone radical lymph node dissection (lymph node removal). This is a patient focused level of research targeted at supportive interventions for patients requiring lymph node removal as part of their melanoma treatment.
Patients were assessed with attendance at a pre and post operative clinic (before and after surgery). The interventions within the study protocol were designed to measure improved quality of life and improved outcomes for patients with a melanoma diagnosis where surgical intervention had involved lymph node removal (Lymphadenectomy/dissections) for the spread of melanoma (metastatic disease). A more consistent pathway was felt to be required to improve patient outcomes including early recognition of development of lymphoedema as well as identifying where increased psychological support post surgery may be required.
The main questions of this study are:
Would provision of a more consistent pathway for patients undergoing lymph node removal pre and post operatively benefit this patient group as part of their normal routine care?
Patients diagnosed with melanoma who have undergone lymph node surgery have unmet supportive care needs. The research looks to determine if a Melanoma Dissection Clinic involving clinical nurse specialists and lymphoedema nurses for stage 3 melanoma patients would benefit patient care and management.
To determine whether early identification of psychological, physical and support issues and early referral for assistance improves patient quality of life and unmet needs assessment.
Participants:
20 patients over the age of 18 years old were recruited via the weekly skin cancer multidisciplinary meetings over a 12-18 month period. The study period was extended by two years due to low recruitment. The recruitment criteria identified patients who were diagnosed with stage 3 melanoma cancer requiring radical lymph node dissection of either the neck, groin or axilla. Diagnosis will have been confirmed through the outcome of a sentinel lymph node biopsy or patients that presented with a palpable lymph node on clinical examination.Patient participants received a series of appointments as follows:
Appointment 1: Pre-operative visit before lymph node surgery Appointment 2: 2-4 weeks post operative following surgery Appointment 3: 3 months post operative Appointment 4: 6 months post operative Appointment 5: 12 months post operative Appointment 6: 18 months post operative Appointment 7: 24 months post operativeAt each appointment the patient will have completed a series of questionnaires titles as follows:
FACT- M (assessing physical, social/family, emotional, functional well-being)
SCNS- SF34 (supportive care needs survey) DASH questionnaire for axilla surgery - upper limb function survey A lower limb functional survey- groin surgery Lymphoedema self assessment surveyThe patient will have had baseline limb measurements taken by a specialist nurse at the first pre-operative appointment using physical measurements with a tape measure and volume assessment using a bioimpedance instrument. A physical assessment by the clinical nurse specialist/lymphoedema nurse or nurse consultant was then carried out at each subsequent appointment. Physical assessment included assessment of any increase in limb volume suggesting lymphoedema by means of measurements of the identified limb. Any lymphoedema or psychological issues identified required referral to appropriate service or the treating surgeon.
No adverse reactions were reported during the study other than progression of melanoma disease and death of some patients on the study from their condition.
Results of study:
20 patients recruited.4 - patients died as result of disease progression during study
4 - patients withdrew for multiple reasons, including poor health, travel and difficulty in attending appointments
12 - patients completed the studyFull analysis of the completed questionnaires has not yet been carried out but once completed will be published. Initial summary of questionnaires depict variation in overall limb function ranging from very little impact to severe impact on quality of life. Early analysis has highlighted early lymphoedema intervention by means of limb volume measurements, some patients requiring compression garments as direct result. Psychological assessment is varied and influenced by social networks. No patient required further psychological referral but received support via skin cancer nurse specialist team and surgeon. It is not possible to depict any long term psychological issues but the potential to offer support at an early stage in this type of clinic is feasible which may impact on improved quality of life.
The study has highlighted the importance of monitoring of increased limb volume for the benefit of early management of lymphoedema with the use of compression garments to reduce swelling and discomfort. Indications are that after lymph node surgery patients experience a short term loss of physical function. The disadvantages are the added hospital exposure for the patient in terms of further appointments and consideration how this service could be built into a skin cancer pathway needs to be evaluated.
It is possible that this study could be replicated across other skin cancer units in the UK.
REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0041
Date of REC Opinion
13 May 2016
REC opinion
Further Information Favourable Opinion