Cancer PatientNCT07560605
The Effect of a Nutrition Education Program
A study testing Nutrition Education Program in people with Cancer Patient, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled trial aimed at evaluating the effect of a nutritional education program on dietary intake and nutritional status in cancer patients. Patients were randomly assigned to intervention and control groups, with the intervention group receiving structured nutritional education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Patient
- What is being tested?
- Nutrition Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 15 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with cancer (>18 years)
- Receiving active cancer treatment (chemotherapy and/or radiotherapy)
- Able to take oral nutrition
- Willing and able to participate in the nutrition education program
- Provided written informed consent
Who cannot join
- Patients receiving enteral or parenteral nutrition
- Severe cognitive impairment or inability to communicate
- Critical or terminal condition preventing participation in education sessions
- Severe comorbidities affecting dietary intake independently (e.g., advanced heart failure, end-stage renal disease)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University, Beşyol Mah. İnönü Cad. No: 38 Küçükçekmece / İstanbul
Istanbul, Istanbul, 34295
About this study
Official title: The Effect of a Nutrition Education Program on Dietary Intake and Nutritional Status in Cancer Patients: A Randomized Controlled Trial
This study is a randomized controlled trial aimed at evaluating the effect of a nutritional education program on dietary intake and nutritional status in cancer patients. Patients were randomly assigned to intervention and control groups, with the intervention group receiving structured nutritional education. Participants' nutritional status and daily dietary intake were assessed at baseline and during the follow-up period. The study aims to demonstrate that nutritional education can increase food intake and be effective in improving nutritional status in patients.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of a structured nutritional education program in improving nutritional status in cancer patients. In cancer patients, the disease itself and the treatments administered (chemotherapy, radiotherapy, etc.) increase the risk of malnutrition due to decreased appetite, taste alterations, nausea, vomiting, and metabolic changes. Therefore, nutritional interventions are critically important for clinical outcomes in this group.
Patients included in the study were randomly assigned to intervention and control groups. The intervention group received an individualized and structured nutritional education program. This program included the importance of adequate energy and protein intake, nutritional strategies for symptoms, appropriate food selection, meal planning, and practical nutritional recommendations. The training was supported by both face-to-face sessions and follow-up interviews as needed. The control group continued with routine clinical care.
The nutritional status of the patients was assessed at baseline and at designated follow-up intervals. Clinical nutritional screening tools (such as NRS-2002), anthropometric measurements (body weight, BMI), and food intake records were used to determine nutritional status. Daily energy and protein intakes of the patients were also analyzed.
The primary aim of this study is to determine whether nutritional education increases patients' dietary intake and consequently reduces their risk of malnutrition. The impact of the educational intervention on patients' nutritional awareness, symptom management, and overall eating behaviors is also evaluated.
The results are expected to contribute to the inclusion of nutritional education as a standard intervention in nursing care for oncology patients and to guide clinical practice.
- Conditions
- Cancer Patient
- Being tested
- Nutrition Education Program
- Keywords
- Cancer patients, Nutritional status, Randomized controlled trial, Nutritional intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education ProgramOther
The intervention consisted of a structured and individualized nutrition education program designed for cancer patients. The program was delivered by a trained healthcare professional and aimed to improve dietary intake and nutritional status. It included education on adequate energy and protein consumption, management of treatment-related symptoms affecting food intake (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs. The intervention was implemented through face-to-face educational sessions with follow-up reinforcement during the study period, in addition to routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group received a structured and individualized nutrition education program in addition to routine clinical care. The intervention was delivered by a trained healthcare professional and focused on improving dietary intake and nutritional status in cancer patients. The program included education on adequate energy and protein intake, management of treatment-related symptoms affecting nutrition (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs. The education was provided through face-to-face sessions with follow-up reinforcement sessions during the study period. Receives: Other: Nutrition Education Program |
| Control Group | No intervention | Participants in the control group received routine clinical care only during the study period. No structured nutrition education or additional dietary counseling was provided beyond standard hospital practices. Patients continued their usual follow-up and medical care as determined by their treating healthcare team. Nutritional status and dietary intake assessments were performed at the same time points as in the experimental group for comparison purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
The Patient Information Form was developed by the researchers in accordance with the relevant literature. It included items related to patients' sociodemographic and clinical characteristics, such as age, gender, educational status, presence and site of metastasis, number of chemotherapy cycles administered at the time of enrollment, chemotherapy schedule, chemotherapy regimen, and type of chemotherapy (adjuvant or neoadjuvant).
Measured: First Day
Subjective Global Assessment
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Measured: First day
Subjective Global Assessment
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Measured: at the 4th week
Subjective Global Assessment
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Measured: at the 8th week
Nutritional Risk Screening
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
Measured: The First day
Nutritional Risk Screening
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
Measured: at the 4th week
Nutritional Risk Screening
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
Measured: at the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start20 Jan 2024
- Primary completion30 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560605
- Sponsor's protocol ID
- Nutrition Education Program
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutrition Education Program on Dietary Intake and Nutritional Status in Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07560605
- Acronym / sponsor ID
- Nutrition Education Program
- Conditions
- Cancer Patient
- Keywords
- Cancer patients, Nutritional status, Randomized controlled trial, Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 1 May 2026 (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.
This study is a randomized controlled trial aimed at evaluating the effect of a nutritional education program on dietary intake and nutritional status in cancer patients. Patients were randomly assigned to intervention and control groups, with the intervention group receiving structured nutritional education. Participants' nutritional status and daily dietary intake were assessed at baseline and during the follow-up period. The study aims to demonstrate that nutritional education can increase food intake and be effective in improving nutritional status in patients.
Detailed description
This study is a randomized controlled trial designed to evaluate the effectiveness of a structured nutritional education program in improving nutritional status in cancer patients. In cancer patients, the disease itself and the treatments administered (chemotherapy, radiotherapy, etc.) increase the risk of malnutrition due to decreased appetite, taste alterations, nausea, vomiting, and metabolic changes. Therefore, nutritional interventions are critically important for clinical outcomes in this group.
Patients included in the study were randomly assigned to intervention and control groups. The intervention group received an individualized and structured nutritional education program. This program included the importance of adequate energy and protein intake, nutritional strategies for symptoms, appropriate food selection, meal planning, and practical nutritional recommendations. The training was supported by both face-to-face sessions and follow-up interviews as needed. The control group continued with routine clinical care.
The nutritional status of the patients was assessed at baseline and at designated follow-up intervals. Clinical nutritional screening tools (such as NRS-2002), anthropometric measurements (body weight, BMI), and food intake records were used to determine nutritional status. Daily energy and protein intakes of the patients were also analyzed.
The primary aim of this study is to determine whether nutritional education increases patients' dietary intake and consequently reduces their risk of malnutrition. The impact of the educational intervention on patients' nutritional awareness, symptom management, and overall eating behaviors is also evaluated.
The results are expected to contribute to the inclusion of nutritional education as a standard intervention in nursing care for oncology patients and to guide clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Nutrition Education ProgramParticipants in the experimental group received a structured and individualized nutrition education program in addition to routine clinical care. The intervention was delivered by a trained healthcare professional and focused on improving dietary intake and nutritional status in cancer patients. The program included education on adequate energy and protein intake, management of treatment-related symptoms affecting nutrition (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs. The education was provided through face-to-face sessions with follow-up reinforcement sessions during the study period. |
| Control Group | No intervention | –Participants in the control group received routine clinical care only during the study period. No structured nutrition education or additional dietary counseling was provided beyond standard hospital practices. Patients continued their usual follow-up and medical care as determined by their treating healthcare team. Nutritional status and dietary intake assessments were performed at the same time points as in the experimental group for comparison purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients diagnosed with cancer (>18 years)
- Receiving active cancer treatment (chemotherapy and/or radiotherapy)
- Able to take oral nutrition
- Willing and able to participate in the nutrition education program
- Provided written informed consent
Key exclusion criteria (4 listed)
- Patients receiving enteral or parenteral nutrition
- Severe cognitive impairment or inability to communicate
- Critical or terminal condition preventing participation in education sessions
- Severe comorbidities affecting dietary intake independently (e.g., advanced heart failure, end-stage renal disease)
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 |
|---|---|---|
| Nutrition Education ProgramThe intervention consisted of a structured and individualized nutrition education program designed for cancer patients. The program was delivered by a trained healthcare professional and aimed to improve dietary intake and nutritional status. It included education on adequate energy and protein consumption, management of treatment-related symptoms affecting food intake (such as nausea, anorexia, and taste changes), appropriate food selection, meal planning strategies, and practical dietary recommendations tailored to individual needs. The intervention was implemented through face-to-face educational sessions with follow-up reinforcement during the study period, in addition to routine clinical care. | Other | Experimental Group |
Primary outcome
Patient Information Form
Time frame: First Day
The Patient Information Form was developed by the researchers in accordance with the relevant literature. It included items related to patients' sociodemographic and clinical characteristics, such as age, gender, educational status, presence and site of metastasis, number of chemotherapy cycles administered at the time of enrollment, chemotherapy schedule, chemotherapy regimen, and type of chemotherapy (adjuvant or neoadjuvant).
Subjective Global Assessment
Time frame: First day
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Subjective Global Assessment
Time frame: at the 4th week
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Subjective Global Assessment
Time frame: at the 8th week
The SGA is a nutritional assessment tool, which has been shown to demonstrate a strong correlation between subjective clinical judgment and objective nutritional measures. Due to its simplicity and predictive validity comparable to objective methods, it is widely used in clinical practice. The SGA includes components such as medical history (weight change over the past six months, dietary intake changes, gastrointestinal symptoms such as anorexia, nausea, vomiting, and diarrhea), as well as functional capacity. Physical examination findings assess subcutaneous fat loss, muscle wasting, and edema, each scored as 0 (normal), 1+ (mild), 2+ (moderate), or 3+ (severe).
Nutritional Risk Screening
Time frame: The First day
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
Nutritional Risk Screening
Time frame: at the 4th week
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
Nutritional Risk Screening
Time frame: at the 8th week
The NRS-2002 aims to identify malnutrition and the risk of malnutrition, and to determine patients who may benefit from nutritional support. The scoring system consists of two sections: 'nutritional status' and 'disease severity,' and allows for scoring as 'no problem,' 'mild,' 'moderate,' and 'severe.' Each section is scored from 0 to 3. In patients over seventy years of age, an additional 1 point is added to the score due to age. Patients with a total score ≥3 are considered to be at nutritional risk.
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 1 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education Program in people with Cancer Patient, run by Istanbul Aydın 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 5 inclusion and 4 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 1 May 2026. 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?
Patient Information Form (time frame: First Day). The study lists 7 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 1 May 2026.