Educational Nursing Intervention Among Patients With Colorectal Cancer During Chemotherapy

NCT04160650 | Completed

• 1 other identifier: NursEff
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Patient Empowerment; Patient Activation; Self Care; Cancer of Colon; Cancer of Rectum

Outcome Measures

Primary Outcomes (2)

• The rate of knowledge level (Knowledge test of malnutrition, nutrition impact side effects and their self-care, RasOma, Tuominen et al. 2019)

  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)

  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 Outcomes (2)

• The incidence of malnutrition risk (Nutritional Risk Screening NRS2002, Kondrup et al. 2003)

  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)

  From the baseline to 8 and 16 weeks after the intervention

Other Outcomes (2)

• Incidence of interruption, transfer and cancellation of the treatments

  From the baseline to 8 and 16 weeks after the intervention

• Incidence of morbidity

  From the baseline to 16 weeks after hte intervention

Study Arms (2)

Educational nursing intervention

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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).

Interventions

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: 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?

Educational nursing intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Turku: lead
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Related Publications (2)

• Tuominen L, Ritmala M, Vahlberg T, Makela S, Nikander P, Leino-Kilpi H. The effect of nurse-led empowering education on nutrition impact side effects in patients with colorectal cancer undergoing chemotherapy: A randomised trial. Patient Educ Couns. 2023 Oct;115:107895. doi: 10.1016/j.pec.2023.107895. Epub 2023 Jul 15.

  PMID: 37473602 DERIVED

• Tuominen L, Ritmala-Castren M, Nikander P, Makela S, Vahlberg T, Leino-Kilpi H. Empowering patient education on self-care activity among patients with colorectal cancer - a research protocol for a randomised trial. BMC Nurs. 2021 Jun 10;20(1):94. doi: 10.1186/s12912-021-00617-z.

  PMID: 34112154 DERIVED

MeSH Terms

Conditions

Patient Participation; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Helena Leino-Kilpi, PhD

  University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded after assignment to interventions, those in intervention and control groups are not aware which treatment they get.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A two-arm, single center, patient blinded superiority trial with stratified randomization (1:1) and with repeated measures

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 13, 2019
• Study Start: October 21, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)