Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Behaviors and Mental Disorders

Recurrence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

The intervention group will receive face-to-face training, giving patient education booklet and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months.

CRCaSSM

Nazli Ozturk, MSC

Akdeniz University Hospital

Fatma Arikan

Objective: The aim of this study was to examine the effects of nursing interventions based on the symptom management model on symptom management, fear of recurrence, and quality of life in colorectal cancer survivors.

Method: The research was planned as a randomized controlled trial. The research is planned to be carried out at Akdeniz University Hospital. It is planned to be done with 52 patients, 26 experimental and 26 control groups. The intervention group will receive face-to-face training and telephone counseling based on the symptom management model. After the training, it is planned to provide telephone counseling for a total of 6 times, once every 2 weeks for 3 months. Participant Information Form, Memorial Symptom Assessment Scale, Fear of Cancer Recurrence Inventory and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale Scale will be used to collect data.

Colorectal Cancer Survivor Symptom Management

The Effect of Nursing Interventions Based on a Symptom Management Model on Symptom Management, Fear of Recurrence, and Quality of Life in Colorectal Cancer Survivors

Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.

Fear of Cancer Recurrence Inventory (FCRI): It consists of 42 items with seven subscales triggers, severity, psychological distress, coping strategies, functioning impairments, insight, reassurance. FCRI, is a Likert-type scale that ranges from 0 (not at all/never) to 4 (all the time/a great deal). Increasing scores received from the scale demonstrate a high level of FCR. The minimum score to be taken from the scale is 0, and the maximum score is 168.

EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.

EORTC QLQ-CR29 The QLQ-CR29 includes 29 items that evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others). Similar to the EORTC QLQ-C30, the QLQ-CR29 has a Likert scale of four response categories (item 48 requires a yes or no answer). All patient-rated scores are linearly converted into a scale from 0 to 100 for both the QLQ-C30 and QLQ-CR29.

Akdeniz University

Research Assistant

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Participants will receive lymphedema education and educational brochures from the researcher on the 2nd day after gynecological cancer surgery.

Routine post-op discharge education is given to patients who undergo gynecological cancer surgery at the institution by nurses on the day of discharge.

On post-op day 2, patients will receive Symptom Management Model-Based Lower Extremity Lymphedema Training. Brochures will be introduced and delivered to the patient.

lymphedema education program

This study aims to examine the effect of lower extremity lymphedema prevention training based on the Symptom Management Model on women undergoing gynecological cancer surgery on lymphedema development, quality of life, and women's self-efficacy. The hypotheses of the study are:

H1a: The quality of life of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is statistically significantly higher than the quality of life of women in the control group.

H1b: The self-efficacy levels of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model are statistically significantly higher than the self-efficacy levels of women in the control group.

H1c: The frequency of experiencing lower extremity lymphedema symptoms of women who underwent gynecological cancer surgery and received lower extremity lymphedema prevention training based on the Symptom Management Model is significantly lower than the frequency of experiencing lower extremity lymphedema symptoms of women in the control group.

Participants will be given training on lower extremity lymphedema. At the end of the study, researchers will evaluate the impact of the training on quality of life, self-efficacy, and lymphedema development.

The incidence of lower extremity lymphedema following gynecological cancer treatment varies depending on the type of gynecological cancer. The prevalence of lymphedema varies between 1-38% in endometrial cancers, 17-81% in cervical cancers, 6-75% in vulvar-vaginal cancers, and 5-21% in ovarian cancers. Studies have shown that the risk of developing lymphedema after gynecological cancer persists in the long term, although the majority of cases occur in the first year. The main factors that increase the risk of developing lower extremity lymphedema are stated as Body Mass Index (BMI), age, The International Federation of Gynecology and Obstetrics (FIGO) cancer stage, lymph node dissection and number of lymph nodes. Lower extremity lymphedema is characterized by symptoms such as unilateral or bilateral swelling, heaviness, pain, itching, numbness, skin changes, infection, etc. These symptoms can seriously affect the patient's quality of life by limiting their daily living activities. Therefore, there is a need for effective interventions to prevent and manage lower extremity lymphedema associated with cancer treatment to improve quality of life and well-being. The training is planned to be structured according to the Symptom Management Model. After gynecological cancer surgery, women's ability to self-diagnose the symptoms they experience related to lymphedema and their responses to these symptoms become part of the management process. In this regard, it is thought that nurse-led education programs positioned in a theoretical framework to prevent lower extremity lymphedema will enable patients to diagnose the early symptoms of lymphedema by improving their knowledge, quality of life, self-efficacy, and reduce the risk of lymphedema. It is anticipated that the model-based nurse-led education program to be developed in this study will be applicable in the clinic and the evidence obtained will guide future research. After obtaining institutional permission, data will be collected by the researcher through a face-to-face interview with women over the age of 18 who meet the inclusion criteria. During this visit, face-to-face information about the research will be given, written consent will be obtained, and data collection tools will be introduced and filled in. The risks of the participants will be determined with the lymphedema risk assessment questionnaire and stratified randomization will be provided accordingly. Research data will be collected with the Socio-demographic Information Form, the Information Form on Cancer Diagnosis, the Lymphedema Risk Assessment Questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Scale, the 6-Item Self-Efficacy Scale for Chronic Disease Management, Gynecological Cancer Lymphedema Questionnaire and Lower extremity circumference measurement. After data collection, the data will be transferred to the Statistical Package for the Social Sciences (SPSS) 26.0 software package for analysis. The data analysis will include percentages, mean values, standard deviations and chi-square test, independent sample t-test, repeated measures ANOVA test, and the corrected Bonferroni test for advanced analyses.

Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery

Development and Evaluation of the Effectiveness of Lower Extremity Lymphedema Education Program After Gynecological Cancer Surgery

The scale questions are answered with a "yes" or "no". GCLQ contains 20 questions that evaluate the presence of symptoms over the past four weeks, scored as 0. If a patient scores 20 points on GCLQ, it indicates the presence of all symptoms, while a score of 0 indicates the absence of all symptoms.

Circumference measurements will be taken in the supine position, moving from the medial malleolus to the inguinal region at 5 cm intervals for both lower extremities. The difference between both extremities will be recorded in cm. A difference of 2 cm between sides measured from at least 6 points is considered significant.

The answers are rated from "not at all" (1 point) to "a lot" (4 points). The last two questions (29th and 30th) are related to the general quality of life and ask the patient to evaluate their health and quality of life in the last week on a scale of 1 to 7 (1 being "very bad" and 7 being "very good"). High scores from these questions indicate high quality of life, while low scores indicate low quality of life.; very bad, 7 points; very good).

The scale consists of six items, with the first four measuring behavioral attitude and the last two measuring psychological attitude. Each item is rated on a 10-point scale ranging from "not at all confident" to "completely confident." To obtain the score, the average of all six items is calculated, with higher scores indicating greater self-efficacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University
Feasibility and Effectiveness of Lymphedema Education Program After Gynecological Cancer Surgery	NCT06251856	Lower Extremity...	lymphedema educ...	18 Years -	Koç University
Colorectal Cancer Survivor Symptom Management	NCT05876338	Colorectal Canc... Survivorship	CRCaSSM	18 Years -	Akdeniz University

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