Colorectal CancerCRCaSSMNCT05876338
Colorectal Cancer Survivor Symptom Management
A study testing CRCaSSM in people with Colorectal Cancer and Survivorship, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Survivorship
- What is being tested?
- CRCaSSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jul 2023to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 1.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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CRCaSSM
- Keywords
- colorectal cancer survivor, symptom management model, fear of recurrence, nursing interventions, quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRCaSSMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CRCaSSM | Experimental | CRCaSSM Receives: Other: CRCaSSM |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start11 Jul 2023
- Primary completion5 Jun 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Ozturk, Akdeniz University
- Investigators
- Fatma Arikan, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876338
- Sponsor's protocol ID
- KAEK-686
- Acronym
- CRCaSSM
- Status last verified
- Feb 2025
- First submitted
- 17 May 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05876338
- Acronym / sponsor ID
- CRCaSSM / KAEK-686
- Conditions
- Colorectal Cancer, Survivorship
- Keywords
- colorectal cancer survivor, symptom management model, fear of recurrence, nursing interventions, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRCaSSM | Experimental | Other: CRCaSSMCRCaSSM |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 1.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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRCaSSMThe 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 |
Primary outcome
Change from Baseline in symptom management at week 12
Time frame: 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.
Change from Baseline in Fear of Cancer Recurrence at week 12
Time frame: 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.
Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale at week 12
Time frame: 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.
Change from Baseline in Quality of Life Level on the EORTC QLQ-CR29 Quality of Life
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Arikan study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRCaSSM in people with Colorectal Cancer and Survivorship, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in symptom management at week 12 (time frame: Baseline, 4th week, 8th week and 12th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.