Prevention of Constipation in Cancer Patients

The Effect of Abdominal Massage in Prevention of Chemotherapy-Induced Constipation

Constipation is the third most common symptom in patients undergoing chemotherapy, with an incidence rate ranging from 31% to 90%. Despite its high prevalence and adverse effects on patients, constipation is often not reported by patients and is not frequently monitored by nurses, resulting in delays in treatment and care. Prolonged constipation can lead to health problems such as fecal impaction/obstruction, hemorrhoids, rectal pain, and intestinal perforation, thereby reducing patients' quality of life. Additionally, increased severity of constipation in cancer patients may lead to the interruption or complete cessation of chemotherapy. Therefore, it is essential to monitor and assess patients for the risk of developing constipation and to implement an effective nursing care protocol.

Abdominal massage is an approach that increases peristalsis, i.e., digestive system movement, by altering intra-abdominal pressure, thereby reducing the severity of constipation.

Study Overview

• Status: Recruiting
• Conditions: Constipation Drug Induced
• Intervention / Treatment: Other: Abdominal Massage

Detailed Description

Cancer is one of the most important health problems in our country and in the world. According to the Global Cancer Observation Data (GLOBOCAN), 9.7 million people lost their lives due to cancer in 2022. There are many methods such as chemotherapy, radiotherapy and surgical treatment in the treatment of cancer. Chemotherapy is the most commonly used of these systemic treatment approaches. Chemotherapy-related gastrointestinal symptoms such as constipation, diarrhea, bloating, incontinence, flatulence and abdominal distension are observed in patients. Constipation is the third most symptom in patients receiving chemotherapy, with a prevalence of 40% to 90%.

Although constipation is common and affects patients negatively, it is not expressed by patients and is not frequently followed up by nurses, resulting in disruptions in the treatment and care process. Prolongation of the constipation process health problems such as fecal impaction / obstruction, hemorrhoids, rectal pain and intestinal perforation and decreases the quality of life of the patients. In addition, increased severity of constipation in cancer patients leads to interruption or complete termination of chemotherapy. Therefore, patients be monitored and evaluated in terms of the risk of constipation development and an effective nursing care protocol should be implemented.

Pharmacologic, non-pharmacologic and surgical methods are used to prevent constipation. Pharmacologic and surgical approaches are quite costly. In the non-pharmacological approach; methods such as increasing fiber food and water consumption, regular exercise, abdominal massage are used. Abdominal massage is a non-invasive nonpharmacologic approach that increases digestive system movement by changing intra-abdominal pressure, reduces the severity of constipation, is safe and has no side effects, and can be applied by nurses with independent decision-making authority and educator role.

This thesis was planned to evaluate "The Effect of Abdominal Massage in the Prevention of Chemotherapy Associated Constipation".

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Can LAFÇI, PhD(c); Phone Number: +90 546 931 90 39; Email: can.lafci@ogr.iuc.edu.tr
• Study Contact Backup: Name: Gülbeyaz CAN, PhD; Phone Number: +90 532 626 49 69; Email: gulbeyaz@istanbul.edu.tr

Study Locations

• Turkey
  • Marmara
    • Istanbul, Marmara, Turkey, 34381
      • Recruiting
      • Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
      • Contact: Can LAFÇI, PhD(c); Phone Number: +90 546 931 90 39; Email: can.lafci@ogr.iuc.edu.tr
      • Contact: Gülbeyaz CAN, PhD; Phone Number: +90 532 626 49 69; Email: gulbeyaz@istanbul.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older,
• Receiving chemotherapy for breast cancer or lung cancer that causes constipation
• Patients who received at least one cycle of chemotherapy and experienced chemotherapy-associated constipation within five days of treatment (stool type 1 or 2 according to the Bristol Stool Scale)
• Volunteers who are willing to participate in the research, can communicate, and can read and write,
• Without psychiatric illness and abdominal obstruction,
• No mass in the abdominal region was detected,
• No intestinal bleeding,
• No history of radiation therapy to the abdominal region,
• No surgical procedures in the abdominal region,
• Patients without intra-abdominal infection, inflammatory bowel disease and irritable bowel syndrome will be included

Exclusion Criteria:

• Patients with stool type 3, 4, 5, 6 and 7 points according to the Bristol Stool Scale

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal Massage Group; Patients will be informed about the abdominal massage application; they will be informed that it should be applied twice a day for five days, 30 minutes after breakfast for 15 minutes and 30 minutes after dinner for 15 minutes. In order to make the massage application more understandable and effective, the abdominal massage application video to be created by the researcher will be shared with the patient and his/her family. After the fifth day of the Abdominal Massage application, patients will be evaluated for the last time with the Bristol Stool Consistency Scale (Appendix-2), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4) and Patient Monitoring and Control Form (Appendix-5).	Other: Abdominal Massage; Abdominal massage is a massage technique performed with soft and rhythmic movements applied to the abdomen. Abdominal massage is an inexpensive, non-invasive, non-harmful, non-invasive method that can be applied by nurses for the treatment of constipation or by teaching the patient and his/her family. During the application of abdominal massage, effleurage (patting), abdominal effleurage , petrissage (kneading), abdominal petrissage maneuvers are applied.
No Intervention: Control Group; Patients who were determined to have constipation as a result of the Bristol Stool Consistency Scale evaluation and assigned to the control group by randomization method will first be administered the Patient Identification Form (Appendix-1), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4), and Patient Monitoring and Control Form (Appendix-5). The researcher will provide information about the "Patient Follow-up and Control Form (Appendix-5)" and the patients will be followed up regularly for five days. After five days of follow-up, the patients will be evaluated with the Bristol Stool Consistency Scale (Appendix-2), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4) and Patient Follow-up and Control Form (Appendix-5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Identification Form	This form was created by the researcher by reviewing the literature. The form included a total of 39 questions about the patient's current disease, descriptive characteristics, socio-demographic characteristics, chemotherapy cycle and regimen, medication use that may cause constipation, performance status score, appetite status, amount of fluid consumed daily, physical activity status, and food group consumed in the last week.	one day
Bristol Fecal Consistency Scale	The Bristol Stool Consistency Scale was developed by Lewis et al. The form of the stool varies according to the transit time through the intestine. With this scale, the stool form is evaluated over seven different stool types. In the scale, 1 and 2 points are evaluated as "hard stool-constipation", 3, 4 and 5 points as "normal stool", 6 and 7 points as "soft-watery stool (diarrhea)".	five days
Constipation Severity Scale	The Constipation Severity Scale (CSS) was developed by Varma et al. in 2008. Its Turkish validity and reliability was performed by Kaya. The scale consists of 16 items to determine the frequency and intensity of defecation and difficulty/difficulty during defecation. The scale has 3 sub-dimensions: "fecal obstruction", "laziness of the large intestine" and "pain". The score that can be obtained from the fecal obstruction sub-dimension is between 0-28, the score that can be obtained from the large intestine sub-dimension is between 0-29, and the score that can be obtained from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious. Cronbach's alpha value of the original scale: 0.88-0.91; Cronbach's alpha of the Turkish scale: 0.92-0.93.	two days
Constipation Quality of Life Scale	The scale, which was developed by Marquis et al. (2005), and validated and reliably analyzed in Turkish (2015), consists of a total of 28 items. This five-point Likert scale consists of 4 sections: 'Anxiety or Worry' (11 items), 'Physical Discomfort' (4 items), 'Psychosocial Discomfort' (8 items) and 'Satisfaction' (5 items). In the Constipation Quality of Life Scale, questions 18, 25, 26, 27 and 28 are reverse items and are calculated by reversing them. A minimum score of 28 and a maximum score of 140 is obtained from this scale. The Cronbach's alpha value of the scale is 0.96. A low total score indicates a high quality of life.	two days
Patient Monitoring and Control Form	It is a simple, easy-to-implement, practical form created by the researcher to monitor the daily nutrients consumed by the patients, to monitor whether abdominal massage is performed, and to ensure that the Bristol Stool Consistency Scale (Appendix-2) evaluations are followed up by the patients and their families.	five days

Collaborators and Investigators

• Sponsor: Marmara University
• Collaborators: Istanbul University - Cerrahpasa
• Investigators: Study Director: Can LAFÇI, PhD(c), İstanbul

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): December 24, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: May 28, 2025
• First Posted (Estimated): June 5, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: chemotherapy; massage; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: İUC-FNHF-CL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No