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NCT Number: NCT04160650

Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

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.

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Key information

Conditions

Patient Empowerment Behavior Cancer of Colon Cancer of Rectum Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Activation Patient Participation Rectal Diseases Rectal Neoplasms Self Care Treatment Adherence and Compliance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer

Behavioral

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

  • In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up?
  • 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?
  • In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up?
  • In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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).

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2019
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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