Colorectal Cancer Survivor Symptom Management

NCT05876338 | Completed

• 1 other identifier: KAEK-686
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Survivorship

Keywords

colorectal cancer survivor; symptom management model; fear of recurrence; nursing interventions; quality of life

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in symptom management at week 12

  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.

  Baseline, 4th week, 8th week and 12th week

• Change from Baseline in Fear of Cancer Recurrence at week 12

  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.

  Baseline and 12th week

• Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12

  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.

  Baseline and 12th week

• Change from Baseline in Quality of Life Level on the EORTC QLQ-CR29 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.

  Baseline and 12th week

Study Arms (2)

CRCaSSM

EXPERIMENTAL

CRCaSSM

Other: CRCaSSM

Control

NO INTERVENTION

Interventions

CRCaSSM OTHER

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

Eligibility Criteria

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

You may qualify if:

• Be 18 years or older
• Being able to read and write
• Being oriented to place, time, person
• Not having a hearing problem
• Not having a speech problem
• Being able to use the phone
• Primary medical diagnosis is colorectal cancer
• Patients who have completed primary treatment for colorectal cancer and are followed up
• Not to relapse
• Being in remission
• Having a Karnofsky Performance Scale of 70% and above and being followed on an outpatient basis

You may not qualify if:

• Patients with cognitive problems
• Patient's wish to leave the study
• Continuing the outpatient follow-up of the patient in the medical oncology outpatient clinic of another institution

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Fatma Arikan

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 25, 2023
• Study Start: July 11, 2023
• Primary Completion: June 5, 2024
• Study Completion: November 6, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)