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Colorectal Cancer Survivor Symptom Management (CRCaSSM)

Primary Purpose

Colorectal Cancer, Survivorship

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CRCaSSM
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer survivor, symptom management model, fear of recurrence, nursing interventions, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 and fill out the online form 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 Exclusion Criteria: Patient's wish to leave the study Continuing the outpatient follow-up of the patient in the medical oncology outpatient clinic of another institution Patients who did not complete 70% of the intervention protocol (training + at least 4 phone consultations)

Sites / Locations

  • Akdeniz University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRCaSSM

Control

Arm Description

CRCaSSM

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2023
Last Updated
July 11, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05876338
Brief Title
Colorectal Cancer Survivor Symptom Management
Acronym
CRCaSSM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Survivorship
Keywords
colorectal cancer survivor, symptom management model, fear of recurrence, nursing interventions, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRCaSSM
Arm Type
Experimental
Arm Description
CRCaSSM
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
CRCaSSM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in symptom management at week 12
Description
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.
Time Frame
Baseline, 4th week, 8th week and 12th week
Title
Change from Baseline in Fear of Cancer Recurrence at week 12
Description
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.
Time Frame
Baseline and 12th week
Title
Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12
Description
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.
Time Frame
Baseline and 12th week
Title
Change from Baseline in Quality of Life Level on the EORTC QLQ-CR29 Quality of Life
Description
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.
Time Frame
Baseline and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 and fill out the online form 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 Exclusion Criteria: Patient's wish to leave the study Continuing the outpatient follow-up of the patient in the medical oncology outpatient clinic of another institution Patients who did not complete 70% of the intervention protocol (training + at least 4 phone consultations)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazli Ozturk, MSC
Phone
+905062409172
Email
nazliozturk@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Arikan
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akdeniz University Hospital

12. IPD Sharing Statement

Plan to Share IPD
No

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Colorectal Cancer Survivor Symptom Management

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