Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

May 23, 2022 updated by: Leena Tuominen, University of Turku

Educational Nursing Intervention on Nutrition Impact Side-effects' Self-care Among Patients With Colorectal Cancer During Chemotherapy: A Research Protocol for a Randomised Controlled Trial

The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects may impact negatively on nutrition intake thus increase the risk of malnutrition and serious complications for patients. Purpose is to test the effect of empowering education on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and malnutrition.

A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and risk of malnutrition measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.

The study will provide knowledge of nurse-led educational intervention on self-care among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of malnutrition is common among patients with colorectal cancer. Chemotherapy induced side effects (nausea, vomiting, pain, mouth sores, fatigue, diarrhea, constipation, distress) may impact negatively on nutrition intake thus increase the risk of malnutrition thus serious complications for patients. Nurse-led empowering education may have positive effect on activation and knowledge level and enhance self-care of this patient group. Studies of nurse-led interventions that may enhance nutrition intake are scarce. Therefore, purpose of this study is to test the effect of educational nursing intervention on activation and knowledge level among patients with colorectal cancer during the chemotherapy. Secondary outcomes are quality of life and risk of malnutrition.

A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures is used to measure the effectiveness of face-to-face education on nutrition intake related chemotherapy induced side-effects' self-care compared to standard care. Eligibility criteria are adult patients diagnosed with colorectal cancer and receiving intra venous chemotherapy treatment. Patients are recruited in one university hospital outpatient clinic in Finland. Experienced oncology nurse delivers the intervention two weeks after the first chemotherapy. Primary outcomes are activation in self-care and knowledge level. Secondary outcomes are quality of life and malnutrition risk measured at baseline (M0) and after eight (M1) and 16 weeks (M2) after the intervention.

The study will provide knowledge of the effectiveness of nurse-led empowering educational intervention on self-care related to chemotherapy-induced side effects that may deteriorate nutrition intake among patients with colorectal cancer. The findings will contribute to patient education and self-care, thus better quality of life.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • able to speak and understand Finnish
  • receiving chemotherapy every three weeks in outpatient clinic: oxaliplatin+capecitabine= Xelox; irinotecan + capecitabine = Xeliri; Xelox or Xeliri + Bevacizumab

Exclusion Criteria:

  • weak physical, psychological or cognitive function that prevents participation
  • not able to understand Finnish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Educational nursing intervention

Patients in experimental group receive standard care and one-hour educational session. Patients are provided knowledge of

  • healthy diet
  • malnutrition, its prevalence and consequences for patients with CRC undergoing CT
  • side effects impairing nutrition intake during CT treatment.
  • prevention and self-care methods of the side effects Teach-back is used to verify participants' understanding. Empowering effect is confirmed by using active listening and asking patients' individual side effects, self-care strategies and need of additional knowledge in the beginning of the session and supporting patients' self-care methods when they have been applicable and effective. Additional knowledge of each theme is offered. To reinforce the intervention effect patients receive after the first CT a self-monitoring diary including assessment of side effects prevalence and intensity (NRS 0-10) before and after the self-care strategies. They return diaries by the 5th cycle of CT.
Behavioral: Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer

This is an educational intervention which aims to answer the questions:

  1. In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up?
  2. In patients with CRC what is the effect of empowering education versus standard education on activation level related to nutrition impact side effects' self-care in 4 months follow-up?
  3. In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up?
  4. In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?
NO_INTERVENTION: Standard care

Patients in control group receive standard care, information of

  • general CT induced side effects and their self-care; nausea, diarrhoea, obstipation and sores in the mouth, peripheral neuropathy symptoms, local venous irritation, heart symptoms, mucous and skin irritation
  • side-effects' self-monitoring, fluid intake, medication dose changes, effect of CT
  • weight control
  • taste alteration
  • cold sensitivity
  • variable diet
  • dietary supplements
  • available dietitian services

They receive a self-monitoring diary, which includes only side effects and their intensity (NRS 0-10).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of knowledge level (Knowledge test of malnutrition, nutrition impact side effects and their self-care, RasOma, Tuominen et al. 2019)
Time Frame: From the baseline to 8 and 16 weeks after the intervention
Knowledge is seen as essential for empowerment (Rankinen et al. 2014; Castro et al. 2016). It is assumed that knowledge level is better in the intervention group compared to control group. Knowledge test was developed in the research group, which included an oncologist, a dietitian, oncology nurses and a researcher. The instrument includes 15 items (yes/no, right answer=1 point, wrong answer=0 points).
From the baseline to 8 and 16 weeks after the intervention
The rate of self care activation (Patient Activation Measure PAM, Insignia Health; Hibbard et al. 2004)
Time Frame: From the baseline to 8 and 16 weeks after the intervention
Activated individuals have the knowledge, skills and confidence to self-manage their health. PAM shows how ready, willing and able an individual is to manage his or her health and healthcare.It is assumed that patients in the intervention group are more activated to self-care their side effects. The activation score is based on a 0-100 point scale. A change of 3-4 points is associated with the difference between engaging and not engaging in particular behaviors. Activation self care is rated from 1 to 4 (1= low activation level; believing the patient role is important, 2=low activation level; having the confidence and knowledge necessary to take action, 3=moderate activation level; actually taking action to maintain and improve one's health, and 4=high activation level; staying the course even in stressful situations)(InsigniaHealth 2017).
From the baseline to 8 and 16 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of malnutrition risk (Nutritional Risk Screening NRS2002, Kondrup et al. 2003)
Time Frame: From the baseline to 8 and 16 weeks after hte intervention
Nutrition consultations have affected positively on patients' food intake and nutritional status (Kiss & Krishnasamy 2014; Tu et al. 2013; Ravasco 2011, 2012). Patients with a total score of ≥3 are classified as nutritionally at risk. It is assumed that malnutrition risk is lesser in the intervention group compared to control group.
From the baseline to 8 and 16 weeks after hte intervention
The rate of quality of life (The Functional Assessment of Cancer Therapy Scale - Colorectal, FACT-C, Cella et al. 1993)
Time Frame: From the baseline to 8 and 16 weeks after the intervention
The risk of malnutrition is strongly associated with QoL in cancer patients initiating chemotherapy (Calderon et al. 2018).The FACT-C questionnaire consists of 36 items on a 5-point Likert scale in four areas of well-being: physical (0-28 points), social (0-28 points), emotional (0-24 points), functional (0-28 points) and CRC subscale (0-28 points). Higher score means better QoL (34 points=low level, 34-68 points= satisfactory, 68-102 points=average and 102-136 points=high)(Ganesh et al. 2016; Goździewicz et al. 2017).
From the baseline to 8 and 16 weeks after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of interruption, transfer and cancellation of the treatments
Time Frame: From the baseline to 8 and 16 weeks after the intervention
Better nutritional status is related to better treatment effect and better well-being, which may lead to better adherence to treatment schedule (Ravasco et al. 2012). Data is collected from patients' records.
From the baseline to 8 and 16 weeks after the intervention
Incidence of morbidity
Time Frame: From the baseline to 16 weeks after hte intervention
Worse nutritional status is related to greater morbidity (Ravasco et al. 2012). Data is collected from patients' records.
From the baseline to 16 weeks after hte intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Helena Leino-Kilpi, PhD, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 21, 2019

Primary Completion (ACTUAL)

March 15, 2022

Study Completion (ACTUAL)

March 15, 2022

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 9, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NursEff

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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