Clinical trial NCT05876338: Colorectal Cancer Survivor Symptom Management
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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Survivorship
Keywords: colorectal cancer survivor
symptom management model
fear of recurrence
nursing interventions
quality of life
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1.Patients with cognitive problems

Exclusion Criteria from the Sample During the Research:

1. Patient's wish to leave the study
2. Continuing the outpatient follow-up of the patient in the medical oncology outpatient clinic of another institution

Primary outcomes:
measure: Change from Baseline in symptom management at week 12
timeFrame: Baseline, 4th week, 8th week and 12th week
measure: Change from Baseline in Fear of Cancer Recurrence at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12
timeFrame: Baseline and 12th week
measure: Change from Baseline in Quality of Life Level on the EORTC QLQ-CR29 Quality of Life
timeFrame: Baseline and 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
Study officials:
affiliation: Akdeniz University
name: Fatma Arikan
role: STUDY_DIRECTOR
References: