CRCaSSM: Colorectal Cancer Survivor Symptom Management

Sponsor
Akdeniz University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05876338
Collaborator
(none)
52
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CRCaSSM
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CRCaSSM

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.

Other: CRCaSSM
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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in symptom management at week 12 [Baseline, 4th week, 8th week and 12th week]

    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.

Secondary Outcome Measures

  1. Change from Baseline in Fear of Cancer Recurrence at week 12 [Baseline and 12th week]

    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.

Other Outcome Measures

  1. Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12 [Baseline and 12th week]

    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.

  2. Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12 [Baseline and 12th week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 and fill out the online form

  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 60% and above and being followed on an outpatient basis

Exclusion Criteria:
  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

  3. Patients who did not complete 70% of the intervention protocol (training + at least 4 phone consultations)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nazli Ozturk, Research Assistant, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05876338
Other Study ID Numbers:
  • KAEK-686
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nazli Ozturk, Research Assistant, Akdeniz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2023