Prevention of Constipation in Cancer Patients

NCT07007468 | Recruiting

• 1 other identifier: İUC-FNHF-CL-01
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation Drug Induced

Keywords

chemotherapy; constipation; massage

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Abdominal Massage Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

Abdominal Massage OTHER

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.

Abdominal Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing

Istanbul, Marmara, 34381, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Can LAFÇI, PhD(c)

  İSTANBUL

  STUDY DIRECTOR

Central Study Contacts

CAN LAFÇI, PhD(c)

CONTACT

+90 546 931 90 39; can.lafci@ogr.iuc.edu.tr

Gülbeyaz CAN, PhD

CONTACT

+90 532 626 49 69; gulbeyaz@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups with a conventional therapy control group

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: May 8, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)