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국문

1. 연구목적
저위전방절제술을 받는 직장암 환자를 위한 회복증진 프로그램을 개발하고 그 효과를 검증하기 위함.

2. 연구배경
1) 필요성
- 우리나라 대장암 발병률 인구 10만명당 45.0명으로 세계에서 가장 높음(WHO, 2015).
- 대장암은 결장암과 직장암으로 분류되며, 결장암의 경우 근치적 수술과 항암화학요법을, 직장암은 방사선요법을 추가로 적용함.
- 수술만 시행했을 때보다 항암화학요법, 방사선요법 등 보조요법을 추가할수록 생존율은 높아지지만, 변실금, 설사, 위장관 증상경험, 성기능장애 등 치료관련 독성이 증가함. 
- 따라서 직장암 환자는 결장암 환자보다 치료 관련 독성에 더 노출될 수 있는 취약한 집단으로 간호요구도가 높음.
- 현재 직장암 표준 수술인 저위전방절제술 후 배변기능장애를 경험하는 환자는 25~80%에 달하며, 이에 따른 삶의질 저하가 심각함.
- 골반저근강화운동은 수술 후 배변기능 향상을 위한 1차적 중재로 고려 가능함.
- 운동 중재는 행위 변화 및 유지가 중요하여 Bandura의 자기효능감 이론이 효과적일 수 있음.

2) 선행연구의 제한점
- 운동 실천 및 유지 이론 기반 중재 프로그램 적용 연구가 부족함. 
- 식이를 포함한 통합 중재 프로그램이 부재하여 증상 완화를 위한 식이 중재를 포함할 수 있음.
- 재입원, 응급실 방문 등 의료자원 이용 및 비용에 대한 고려가 부족함.
- 국내 연구의 경우, 직장암 환자의 질병 경험에 대한 질적연구, 불안, 우울, 사회적지지, 배변기능 및 건강관련 삶의질 간의 관계를 확인한 조사연구가 대부분으로 중재연구는 부족한 실정임.

3. 연구가설
- 가설 1: 실험군은 대조군에 비해 (시간의 경과에 따른) 자기효능감이 높을 것이다.
- 가설 2: 실험군은 대조군에 비해 (시간의 경과에 따른) 배변기능이 좋을 것이다.
- 가설 3: 실험군은 대조군에 비해 (시간의 경과에 따른) 건강관련 삶의 질이 높을 것이다. 
- 가설 4: 실험군은 대조군에 비해 의료자원 이용이 감소할 것이다.

4. 연구방법
1) 연구대상자: 서울 1개 상급종합병원에서 직장암을 진단 받고 저위전방절제술을 받은 성인 남성 환자
2) 연구설계: 무작위 대조군 전후 실험 설계
3) 실험적 처치: Bandura의 자기효능감 이론 기반 4주간의 중재 프로그램(운동 교육, 시범, 수행 확인 및 식이 및 증상관리 교육)
4) 효과평가
- 자기효능감: general self-efficacy (GSE) 도구 이용하여 측정한 점수(자가설문)
- 배변기능: low anterior resection syndrome (LARS) score 도구 이용하여 측정한 점수(자가설문)
- 건강관련 삶의질: European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire (EORTC-QLQ-CR) 29 도구를 이용하여 측정한 점수(자가설문)
- 의료자원이용: 의료기관 연락 빈도, 기대하지 않은 재입원/응급실 방문/외래 방문/약국 이용, 추가 발생 의료비용
- 운동수행율(운동일지)
- 일반적/수술 및 질병 관련 특성(EMR): 연령, 키, 체중, 교육수준, 보호자, 종교, 병기, ASA, ECOG, 종양위치, 수술종류, 절제범위, Loperamide, 5-HT3 antagonist, (Neo) adjuvant theraphy, length of stay, 운동수행율
5) 통계분석방법
- 일반적/수술 및 질병관련 특성: 평균±표준편차, 빈도/백분율, 중위수±IQR
- 동질성 검증: Independent t-test, chi-square test, Fisher’s exact test, Mann-Whitney U test
- 시점별 효과 평가: Independent t-test, Mann-Whitney U test, ANCOVA, regression
- 시간경과에 따른 효과평가: RM ANOVA, LMM, GEE
- 중도탈락: ITT analysis, PPA

영문

1. Purpose
To develop a recovery enhancement program for rectal cancer patients undergoing low anterior resection and to test its effectiveness

2. Background
1) Introduction
The prevalence of colorectal cancer in Korea is the highest in the world (45.0 per 100,000 population) (WHO, 2015). Colorectal cancer is classified as colon cancer and rectal cancer. In the case of colon cancer, surgery and chemotherapy are used for treatment, and radiation therapy is added to rectal cancer. The more the adjuvant therapies such as chemotherapy and radiotherapy are added, the higher the survival rate. However, the treatment related toxicity such as fecal incontinence, diarrhea, gastrointestinal symptom experience, sexual dysfunction increases. Therefore, rectal cancer patients are more vulnerable to treatment-related toxicity than colon cancer patients and have high needs for nursing care.
Currently, 25~80% of patients experience bowel dysfunction after low anterior resection of rectum, resulting in severe quality of life deterioration. Pelvic floor muscle training can be considered as a primary intervention to improve post-operative bowel function. In the case of exercise intervention, the behavior change and maintenance are important, and Bandura's self-efficacy theory may be effective.

2) Limitations of previous studies
- Lack of theory based intervention program focus on exercise performance and maintenance.
- Absensce of an integrated intervention program that includes diet.
- Lack of consideration of healthcare resource utilization and costs such as readmission, emergency room visit, etc.
- In Korea, most studies were observational studies investigating the relationship between anxiety, depression, social support, bowel function and health-related quality of life in rectal cancer patients.
- Insufficient intervention studies.

3. Hypotheses
1) The experimental group will have higher self-efficacy (over time) than the control group.
2) The experimental group will have better bowel function (over time) than the control group.
3) The experimental group's health-related quality of life will be higher (over time) than the control group.
4) The experimental group will have less use of healthcare resources than the control group.

4. Methods
1) Participants: Adult male patients diagnosed with rectal cancer and underwent low anterior resection in a tertiary hospital in Seoul
2) Study design: a randomized controlled trial
3) Treatment: 4-weeks intervention program(exercise eduation, demostration and performace, dietary education, symptom management education) based on Bandura's self-efficacy theory
4) Measurements
- Self-efficacy: self-reported score by general self-efficacy (GSE) scale
- Bowel function: self-reported score by low anterior resection syndrome (LARS) scale
- Health-related quality of life: self-reported score by European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire (EORTC-QLQ-CR) 29 scale
- Healthcare resources utilization: Frequency of contact with hospital, unplanned readmission/emergency department visit/outpatient department visit/utilzation of pharmacy, additional medical expenses
- Exercise performance rate (exercise diary)
- General/surgery and disease related characteristics(EMR): age, height, weight, education level, caregiver, religion, stage, ASA, ECOG, site of tumor, type of surgery, range of excision, Loperamide, 5-HT3 antagonist, (Neo) adjuvant theraphy, length of stay
5) Statistical analysis
- General/surgery and disease related characteristics: mean±standard deviation, frequency/percentage, median±interquartile range
- Homogeneity test: Independent t-test, chi-square test, Fisher’s exact test, Mann-Whitney U test
- Test of effects by time points: Independent t-test, Mann-Whitney U test, ANCOVA, regression
- Test of effects over time: RM ANOVA, LMM, GEE
- Attrition: intention-to-treat(ITT) analysis, per-protocol analysis (PPA)

국문

1. 실험군
1) 1주차: 퇴원 전 날
- 목표: 식이관리, 증상관리, 운동수행
- 교육내용: 직장의 기능, 저위전방절제술증후군의 정의, 직장암 수술 환자들의 질병 경험, 골반저근강화운동 목적 및 방법, 식이관리 방법, 일반적인 수술 후 관리(증상관리)
- 교육방법(전략): 면대면, 태블릿 PC 이용, 운동 시범 및 수행 확인, 운동 영상 제공 (휴대폰, USB), 보호자 참여, 운동/식이일지 교육
- 시간: 30분
2) 2주차: 첫 외래 방문
- 목표: 운동점검, 동기부여(강화)
- 교육내용: 골반저근강화운동 성공사례 소개, 골반저근강화운동 수행 적절성 점검
- 교육방법(전략): 면대면, 성공사례 소개(인쇄물), 문자메시지, 운동/식이일지 기록
- 시간: 30분
3) 3주차: 퇴원 후 3주
- 목표: 이행점검, 장애요인 확인
- 교육내용: 골반저근강화운동 이행도 및 수행의 어려움 확인, 신체적/심리적 상태 확인 및 코칭, 정서적 지지
- 교육방법(전략): 전화코칭, 문자메시지, 운동/식이일지 기록
- 시간: 10-20분
4) 4주차: 퇴원 후 4주
- 목표: 장애극복, 운동유지
- 교육내용: 성공적인 골반저근강화운동 경험에 대한 논의, 운동 지속 유지 계획 설정
- 교육방법(전략): 전화코칭, 문자메시지, 운동/식이일지 기록
- 시간: 10-20분

2. 대조군: 일반적인 치료

영문

1. Experimental Group
1) Week 1st: Before the day of discharge
- Goal: Dietary management, symptom management, exercise
- Contents: Function of the rectum, definition of low anterior resection syndrome (bowel dysfunction), disease experience of rectal cancer patients, purpose and method of pelvic floor muscle training (PFMT), diet management, postoperative management (symptom management)
- Education method (strategy): face-to-face, tablet PC, exercise demonstration and practice, exercise video provision (mobile phone, USB), primary caregiver participation, exercise/diet diary education
- Time: 30 minutes
2) Week 2nd: First outpatient visit
- Goal: exercise check, motivation (reinforcement)
- Contents: Introduction of a successful case of PFMT, Check of suitability of PFMT
- Education Method (Strategy): face-to-face, introduction of a successful case (printed material), text messages, exercise/diet diary records
- Time: 30 minutes
3) Week 3rd: 3 weeks after discharge
- Goal: Exercise adherence check, Identification of barriers of PFMT
- Contents: Identification of difficulties in performance and maintenance of PFMT, physical/psychological state check and coaching, emotional support
- Education Method (Strategy): telephone coaching, text messages, exercise/diet diary records
- Time: 10-20 minutes
4) Week 4th: 4 weeks after discharge
- Goal: Overcoming the barriers, maintaining PFMT
- Contents: Discussion on successful PFMT experience, planning of PFMT maintenance
- Education Method (Strategy): telephone coaching, text messages, exercise/diet diary records
- Time: 10-20 minutes

2. Control Group: Usual care

상세내용 영문

Usual care

상세내용 영문

1) Week 1st: Before the day of discharge
- Goal: Dietary management, symptom management, exercise
- Contents: Function of the rectum, definition of low anterior resection syndrome (bowel dysfunction), disease experience of rectal cancer patients, purpose and method of pelvic floor muscle training (PFMT), diet management, postoperative management (symptom management)
- Education method (strategy): face-to-face, tablet PC, exercise demonstration and practice, exercise video provision (mobile phone, USB), primary caregiver participation, exercise/diet diary education
- Time: 30 minutes

2) Week 2nd: First outpatient visit
- Goal: exercise check, motivation (reinforcement)
- Contents: Introduction of a successful case of PFMT, Check of suitability of PFMT
- Education Method (Strategy): face-to-face, introduction of a successful case (printed material), text messages, exercise/diet diary records
- Time: 30 minutes

3) Week 3rd: 3 weeks after discharge
- Goal: Exercise adherence check, Identification of barriers of PFMT
- Contents: Identification of difficulties in performance and maintenance of PFMT, physical/psychological state check and coaching, emotional support
- Education Method (Strategy): telephone coaching, text messages, exercise/diet diary records
- Time: 10-20 minutes

4) Week 4th: 4 weeks after discharge
- Goal: Overcoming the barriers, maintaining PFMT
- Contents: Discussion on successful PFMT experience, planning of PFMT maintenance
- Education Method (Strategy): telephone coaching, text messages, exercise/diet diary records
- Time: 10-20 minutes

영문

Rectal Neoplasms; Colorectal Surgery

영문

Bowel function

영문

Baseline (the day before discharge after surgery), 1month after surgery (immediately after intervention), 3months after surgery

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Health-realted quality of life

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Baseline (the day before discharge after surgery), 1month after surgery (immediately after intervention), 3months after surgery

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Self-efficacy

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Baseline (the day before discharge after surgery), 1month after surgery (immediately after intervention), 3months after surgery

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Healthcare resources utilization

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1month after surgery (immediately after intervention), 3months after surgery