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Educational Nursing Intervention on Nutrition Intake Related Chemotherapy Induced Side-effects' Self-care Among the Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04160650
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Leena Tuominen, University of Turku

Brief Summary:

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. Nurse-led empowering education may have positive effect on self-care activity of this patient group. Therefore, purpose is to test the effect of educational nursing intervention on self-care activity 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 malnutrition risk 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 activation related to chemotherapy-induced side effects that may deteriorate nutrition intake among patients with colorectal cancer. The findings will contribute to patient education and better self-care of nutrition related side effects, thus better quality of life.


Condition or disease Intervention/treatment Phase
Patient Empowerment Patient Activation Self Care Cancer of Colon Cancer of Rectum Behavioral: Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures
Masking: Single (Participant)
Masking Description: Participants are blinded after assignment to interventions, those in intervention and control groups are not aware which treatment they get.
Primary Purpose: Supportive Care
Official Title: Educational Nursing Intervention Among the Patients With Colorectal Cancer - a Research Protocol of Randomised Controlled Trial
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160650


Contacts
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Contact: Leena Tuominen, MNSc +358440421371 leetuo@utu.fi
Contact: Marita Ritmala-Castrén, PhD +358503095518 marita-ritmala-castrén@hus.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Leena Tuominen, MNSc    +358440421371    leetuo@utu.fi   
Contact: Marita Ritmala-Castrén, PhD    +3583095518    marita.ritmala-castren@hus.fi   
Sponsors and Collaborators
University of Turku
Helsinki University Central Hospital
Investigators
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Principal Investigator: Helena Leino-Kilpi, PhD University of Turku
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leena Tuominen, Principal Investigator, University of Turku
ClinicalTrials.gov Identifier: NCT04160650    
Other Study ID Numbers: NursEff
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases