Implementation Context and Setting
This QI project took place from June 2021 - October 2021 in the department of GI Surgical Oncology and Oncology Rehabilitation at a single large tertiary cancer care institution in Southeast U.S., including surgical oncologists, medical oncologists, radiation oncologists, nurse practitioners, physical therapists (PTs), nurses, nursing assistants, and dieticians. The department of GI Surgical Oncology has three practicing surgical oncologists and one full-time nurse practitioner (NP). An average of 50-55 new patients are seen annually for CRC treatment and LAR surgery. During project development, over 30established CRC patients with LARS continued their cancer surveillance with the practice. The facility Institutional Review Board (IRB) approved this project and deemed it a QI initiative. A Model for Change to Evidence-Based Practice by Rosswurm and Larrabee was used to guide development and implementation [19].
Interventions
A convenience sample was used for this QI project. The target population was adult patients with either rectosigmoid or rectal cancer and a surgical treatment plan for LAR, or any patient 0 - 24 months postoperative from LAR or post-LAR ostomy closure with existing LARS. LARS severity and QOL can be improved early in symptom course but may take up to 24 months; thus, this criterion was used as reference point for this QI project.
Patients were categorized into three groups; “low risk”, “high risk”, and “established”. For newly diagnosed CRC patients, the surgeons discussed the QI project at initial consultation; capturing the “low risk” and “high risk” patients. A fact sheet detailing a brief overview of LARS, PFR intervention, project aims, and contact information was provided at consultation. The project lead then contacted individual patients to gauge interest. “Established” patients were captured by both the NP and surgeons during regularly scheduled surveillance visits, or when LARS was diagnosed. All patients received the same fact sheet reviewing project details and LARS. The high- and low-risk groups had initial PFR intervention pre-CRC treatment, exploring PFR as a preventative measure for LARS. The “established” group had PFR intervention following CRC treatment and LAR surgery, exploring the use of PFR to treat LARS.
The intervention included 1-hour PFR physical therapy sessions with the pelvic physical therapist and 5 minutes of daily self-led pelvic floor muscle exercises. The PERFECT assessment (Power, Endurance, Repetitions, Fast contractions, and Every Contraction Timed), a digital assessment of pelvic floor muscle engagement, was performed by the PT at each session to guide patients on exercise technique and inform future goals. The PERECT assessment has high inter-examiner reliability (p < .001), test-retest reliability (p < .001), and validity (p = .001) [20]. Patient-reported outcome questionnaires included the LARS Score and FiQOL Scale, completed before most PFR sessions and at the 3-month follow-up appointment with the clinician.
Collection of outcome measurements varied (Table 1). The “low risk” and “high risk” groups did not receive FIQOL Scale pre-PFR, it was not expected these patients have impaired QOL related to fecal incontinence prior to treatment. Differences in treatment for locally advanced and low-risk rectal cancer, rectosigmoid, and sigmoid colon cancer informed the number of sessions for each group. The justification for this approach is the aim to utilize PFR as a preventative measure prior to CRC treatment in both high- and low-risk groups.
The clinical staff vital in project promotion and progresswere SJ (nurse practitioner, project lead) and ET (pelvic physical therapist). Three key clinical nursing staff (SO, BG, and KZ) issued the fact sheet to patients and informed project lead of potential patients after initial consult or follow-up visit. The project lead assumed primary role for data import into the data warehouse. The three surgeons helped capture appropriate patients in initial consult and define treatment algorithms.
Table 1 Treatment Intervention Timeline. Patients were categorized into three groups: “low risk” (rectosigmoid colon cancer or T1/T2 N0 rectal cancer), “high risk” (locally advanced T3/T4 or N-positive rectal cancer with surgical plan for LAR, or any T any N-positive rectal cancer patient treated with neoadjuvant radiation with surgical plan for LAR), and “established” (patient post-LAR surgery or ostomy closure after previous LAR surgery with existing LARS).
Group Description
|
Session 1
|
Session 2
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Session 3
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Session 4
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Session 5
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Group 1:
“Low Risk”
|
Treatment timeline
|
2 weeks pre-op
|
2 weeks post-op
|
6 weeks post-op
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3 months post-op
|
---
|
Interventiona
|
X
|
X
|
X
|
---
|
---
|
Outcome measuresb
|
Xc
|
X
|
X
|
X
|
---
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Group 2:
“High Risk”
|
Treatment timeline
|
2 weeks pre-radiation
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2 weeks pre-op (LAR)
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2 weeks post-opd
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6 weeks post-opd
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3 months post-opd
|
Interventiona
|
X
|
X
|
X
|
X
|
---
|
Outcome measuresb
|
Xc
|
X
|
X
|
X
|
X
|
Group 3:
“Established”
|
Treatment timeline
|
Initial evaluatione
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2 weeks after initial evaluation
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6 weeks after initial evaluation
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3 months after initial evaluation
|
---
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Interventiona
|
X
|
X
|
X
|
---
|
---
|
Outcome measuresb
|
X
|
X
|
X
|
X
|
---
|
Note: “X”: intervention or outcome measure collection; “---”: no intervention or data collection per project protocol
a1-hour session of PFR with physical therapist; b LARS Score and FiQOL Scale; cLARS Score only; d Post-LAR ostomy closure or post-op LAR if no ostomy; e When diagnosed with LARS
Study of the Interventions
Patients often use a multi-therapy approach for LARS treatment. Strong evidence supports PFR as a treatment for LARS compared to other therapies, irrespective of timing from bowel continuity or symptom duration [16]. There is no literature showing PFR as a preventative strategy for LARS prior to definitive CRC treatment. Establishing a protocol, identifying the prevalence of LARS, and incorporating PFR as a preventative measure and treatment offers strong potential to enhance patient care and improve outcomes.
Measures
A number of instruments are used to assess bowel dysfunction; however, many focus on a single component of the condition and do not evaluate QOL [8, 10]. The LARS Score is a 5-question patient-reported outcome instrument that categorizes LARS based on severity on a binomial scale of either minor or major LARS; it is validated in English and has strong convergent validity in QOL (p < .01) and discriminative validity (p < .02), and high test-retest reliability (intraclass correlation coefficient 0.83) [6, 14]. The LARS Score assesses five different bowel dysfunction symptoms, including fecal incontinence, frequency, urgency, clustering, and indiscrimination of gas versus stool.
The Fecal Incontinence Quality of Life (FiQOL) Scale is commonly used to evaluate QOL due to fecal incontinence, a hallmark symptom of LARS. It includes 29 questions measuring QOL in four domains, including lifestyle, coping/behavior, depression/self-perception, and embarrassment. Scores range from 1 to 5, higher scores indicating better quality of life. Psychometric evaluation shows both tools produce reliable and valid measurements [3, 6, 14].
Analysis
Power analysis revealed a sample size of 30 would provide adequate effect. Data analyses were conducted via IBM SPSS Statistics 27 software. Descriptive statistics were used to summarize demographic and diagnostic data, evaluate patient acceptance, and summarize reasons for opting out. Chi squared and Fisher’s exact tests were used to evaluate categorical data among groups. Fisher’s exact test of retrospective data was used to compare the prevalence of LARS among groups. Kruskal Wallis tests were used to examine change in QOL median scores among LARS severity at various timepoints. A p value of < .05 was considered statistically significant. This manuscript was written per SQUIRE 2.0 Guidelines [21, 22].
Ethical Considerations
This project was performed in accordance with the Declaration of Helsinki. Approval was granted by facility IRB and determined to be quality improvement. No direct or indirect ethical considerations of project development or implementation were identified.