Quality of Life and Outcomes in Patients with Malignancies of the Groin


Name

Target measurement

Logistics of administration

Comments and use

Generic quality of life assessment tools

Sickness Impact Profile (SIP)

• Measures perceived health status based on impact on behavior

• Interviewer- or self-administered

• 136 items over 12 areas of dysfunction

• 20–30 min to complete

• Designed for new treatments and health levels in populations

EuroQol (EQ-5D)

• Measures physical, mental, and social function

• Interviewer- or self-administered

• 5 items over five areas

• 2 min to complete

• Designed as a general-purpose tool

• Useful for cost utility evaluation

• Extreme simplicity

• Best used with other tools

36-Item Short Form (SF-36)

• Measures physical, social, and emotional function

• Interviewer- or self-administered

• 36 items over eight health areas

• Generic health concepts with diverse applications

• Most widely used

Patient Generated Index (PGI)

and

Schedule for Evaluation of Individual Quality of Life (SEIQoL)

• Measures five areas as chosen by the patient

• Interviewer- or self-administered

• Scales and scoring are slightly different between PGI and SEIQoL

• PGI is more simple

• Can identify issues important to an individual patient

• Less helpful for clinical trials and comparing groups

Disease-specific assessment tools

European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

• Cancer-specific different modules for different diseases

• Focus on clinical symptoms and ability to perform

• Interviewer- or self-administered

• 30 items

• Applicable across multiple cultural settings

• Used for clinical trials

• Very sensitive tool

Functional Assessment of Cancer Therapy-General (FACT-G)

• Cancer-specific different modules for different diseases

• Focus on feelings and concerns

• Interviewer- or self-administered

• 27 items

• Applicable across multiple cultural settings

• Similar to EORTC QLQ-C30 difference is the focus

Rotterdam Symptom Checklist (RSCL)

• Cancer specific

• Focus on symptoms and side effects

• Interviewer- or self-administered

• 30 items

• Question style differs from EORTC QLQ-C30 and FACT-G

• Used for clinical trials

Dimension-specific assessment tools

McGill Pain Questionnaire (MPQ)

• Measures pain levels

• Interviewer- or self-administered

• 20 items

• 5–15 min to complete

• A shorter SF-MPQ exists

Barthel Index of Disability (BI)

• Measures disability, assesses ADLs

• Usually interviewer-administered

• 10 items

• 1 min to complete

• Used for measuring rehab outcomes

Multidimensional Fatigue Inventory (MFI)

• Measures fatigue

• Usually self-administered

• 20 items
 



The SF-36


In the early 1990s, Ware et al. conducted a multicenter trial entitled the Medical Outcomes Study (MOS) [4]. The aim of this study was to produce a health-related quality of life assessment tool that would serve as a “happy medium” between lengthy, all-inclusive tools and the shorter, crude instruments. The result of the MOS was the Short Form 36 (SF-36). The SF-36 is a by-product of previous assessment tools. It incorporates and focuses on the dimensions that are most frequently affected by treatments and disease, as well as those most often measured in healthcare surveys. Because of its efficiency and comprehensive nature, the SF-36 remains one of the most widely used assessments of health-related quality of life. Over the years, various versions and updates have been produced. The most current version is the SF-36v2. Other shorter versions of the SF-36 have been developed: SF-12, SF-8, and SF-6D.

As its name would suggest, the SF-36 consists of a total of 36 questions. The questions span a total of eight health dimensions and are ultimately broken down into an evaluation of physical health and mental health. Within the physical health domain are items measuring physical functioning (ten items), role functioning (four items), bodily pain (two items), and general health (five items). Within the physical health domain are items measuring vitality (four items), social functioning (two items), role emotional (three items), and mental health (five items). Designers of the SF-36 have tested and validated the above questions so that they can be scored against a standard scoring method. Logistically, the questionnaire can either be self-assessed or administered by a trained interviewer.



Malignancies of the Groin


There are four main oncologic diseases that involve the inguinal and groin region: melanoma, penile cancer, soft tissue sarcoma, and vulvar cancer. Soft tissue sarcoma would present as a primary site of disease in the groin. Otherwise inguinal lymph nodes serve as a site of regional metastasis for primary diseases of the pelvis, trunk, and lower extremities. Metastatic disease can be identified at the time of initial presentation or as a site of recurrence.

The mainstay of treatment for malignancies of the groin is surgical resection. Resection can take many forms including extirpation of primary or recurrent disease, sentinel lymph node biopsy, and completion lymph node dissection. Indications and technical aspects of these procedures, including the nuances of critical anatomic structures, are discussed elsewhere. There is often a direct relationship between increased complexity of resection and increased morbidity, with an ensuing negative impact on QoL. The use of radiotherapy is infrequently substituted for resection, but is not uncommonly considered as an adjunct to resection. In such situations, the impact on appearance and function can be severe and must be weighed when considering risks versus benefit of treatment.

As discussed above, quality of life is a complex construct. With regard to malignancies of the groin, this complexity makes no exceptions. One can imagine a multitude of factors that impact a patient’s QoL. Often, we experience QoL in the context of a negative impact after treatment, but it should be noted that sometimes patients suffering from oncologic diseases experience a positive effect. The term “response shift ” has been used to capture the shift in internal standards, values, and conceptualization of QoL. Receiving a cancer diagnosis gives some patients a different outlook on life and improves QoL measurement in response to treatment. It is difficult, if not nearly impossible, to study all the effects of a disease on QoL.

Over time, several disease-specific assessment tools have been developed. For example, there are QoL instruments that have been validated and tested for vulvar cancer and melanoma—the FACT-V and FACT-M, respectively. Generic instruments, such as the EORTC QLQ-C30 and SF-36, are extremely good for an overall, broad QoL assessment. These tools are also advantageous for comparisons between disease states. As expected, the more refined, disease-specific instruments are better able to detect and compare disease-specific areas of impact. For example, the FACT-M will better detect the psychological and social impact that avoiding sun exposure has on melanoma patients.

The intent of the next several sections is to provide an overview of QoL with specific consideration to disparate disease types, noting currently clinical evidence when it is available. Risks associated with progressive disease and its impact on survival outcomes as well as overall function and QoL are the major considerations when deciding to proceed with an operation. However, because complications are relatively common with resection and/or ILND, risks and benefits must be fully considered.


Quality of Life and Melanoma (with Inguinal Nodal Basin Involvement)


At one time, melanoma was a rare form of cancer. Since the mid-1950s, however, its incidence is increasing faster than any other form of cancer. For some, melanoma is a chronic disease that portends a lifetime of risk factor mitigation and careful surveillance. For intermediate and thick tumors, the likelihood of lymph node metastasis is much more frequent, and when the disease is located on the lower extremities or trunk, regional spread to the inguinal nodes must be evaluated.

In the past, inguinal lymph node dissections (ILND) were performed in either an elective setting (ILND done preemptively to diagnose and treat) or a therapeutic setting (ILND done in the setting of diagnosed (palpable) disease). The presumed trade-offs of elective ILND were early removal of disease at a microscopic level versus unnecessary removal of nodes that never would have developed disease. With the advent of sentinel lymph node biopsy (SLNB), the rates of ILND decreased, since such a procedure was reserved for those with known disease, presumably found at a much earlier stage. Current controversies around the need for completion ILND revolve around the question of whether there is any therapeutic effect of ILND following SLNB.

While many studies considered surgical complications, data on the dimensions of QoL were lacking. The surgical management of metastatic disease to the groin is fraught with morbidity and complications. Overall, wound complication rates following inguinal lymph node dissections are reported in up to 71% of patients [5]. Frequent complications include seroma (17%), wound infection (9%), wound necrosis (3%), and edema (20%) [6]. Fortunately, complications appeared to decline with more minimally invasive procedures. The complication rate for a SLNB is between 4.6 and 10.1% [7]. Several studies, including the Sunbelt Melanoma Trial, have demonstrated that the morbidity with SLNB is less than compared to SLNB plus CLND. Further, surgical techniques that utilize a minimally invasive approach have shown some promise to reduce complications, particularly wound-related ones [8, 9]. Additional longitudinal QoL data will be important as approaches to inguinal nodal disease are continuously evaluated.

Bulky adenopathy of the iliac and inguinal nodes can result in lymphedema, vascular compromise, neuropathy/pain, or locoregional wound complications (either associated with involvement of nearby structures or overlying skin). Similarly, feared complications resulting from inguinal node dissections include lymphedema, ranging from relatively asymptomatic edema based on serial leg measurements to massive lymphedema which limits physical functioning; vascular compromise, including venous thrombosis; neuropathy from direct damage to nerves; or nonhealing wounds/infectious complications. Several techniques accompanying ILND include preservation of the muscle fascia, pedicled omentoplasty, sartorius transposition, and saphenous vein sparing and have been developed in an attempt to mitigate complications, without much improvement. Despite all of the above data around morbidity of groin dissections, studies have shown that the QoL of survivors is essentially comparable to the general population [7, 10]. The exact reason for this lack of impact is unknown though possible explanations include concepts such as response shift, survival bias, as well as a selection bias.

Because the majority of patients have a good functional outcome, many believe that the major impact on QoL is psychological. A systematic review of QoL in melanoma patients supports this claim. Approximately a third of all patients will experience a significant level of distress. This effect peaks around the time of diagnosis and shortly after treatment but then decreases with time. Poor preoperative health status and psychological illness are predictors of postoperative QoL impairment [11]. Even worse, studies have shown an association between QoL impairment, psychological factors, and personality structure that may affect survival [11, 12]. The cause for such psychological distress is largely unknown. The finding that approximately 85% of patients did not receive adequate treatment or assessment for psychological distress during surveillance, however, is equally concerning. Like all of the diseases reviewed here, this highlights the need and importance of continued work with QoL in patients. It also shows how important preoperative and continued postoperative psychosocial care is to QoL.

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Feb 26, 2018 | Posted by in GYNECOLOGY | Comments Off on Quality of Life and Outcomes in Patients with Malignancies of the Groin

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