NCT05940740

Brief Summary

The incidence of colorectal cancer ranks fourth worldwide after lung, prostate and breast cancers. Although chemotherapy has an important place in the treatment of colorectal cancers, it can cause side effects such as diarrhea and fatigue in patients. Cancer patients' ability to cope with treatment side effects can be benefited from technological developments. Studies have shown that mobile health applications reduce symptom experience and increase quality of life in patients with breast cancer and leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

April 14, 2023

Last Update Submit

July 9, 2025

Conditions

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • Functional Assessment of Cancer Therapy-Colorectal

    The Functional Assessment of Cancer Therapy-Colorectal Scale was first developed by Ward et al. in 1999 in the USA by the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. The scale consists of a total of 5 dimensions and a total of 46 items. The scale consists of Ordinary Physical Status sub-dimension, Social Life and Family Status sub-dimension, intense Status sub-dimension, Activity Status sub-dimension and Other Concerns sub-dimensions. In the evaluation made with the FACT-C Scale, the subject is asked to answer each statement by observing the last 7th day indicator. Each item of the scale is evaluated on a 5-point Likert-type scale ("never" = 0, "very little" = 1, "some" = 2, "quite" = 3, "a lot" = 4). Its total score is between 0-136.

    Two weeks

  • Patient Information Form

    The Patient Information Form was prepared considering the factors that may affect the self-care of patients diagnosed with colorectal cancer who underwent outpatient chemotherapy within a year. This form consists of a total of 19 questions questioning the characteristics of the individual, the disease and the treatment.

    Two weeks

  • Nightingale Symptom Evaluation Scale

    The Nightingale Symptom Evaluation Scale (2009) was developed by Can and Aydıner for patients diagnosed with cancer. The scale includes three sub-dimensions. These sub-dimensions are "Physical Well-Being", "Social Well-Being" and "Psychological Well-Being". The answers given by the patients to the scale are scored from 0 to 4 and answered on a five-point Likert type scale. Patients are asked to evaluate these questions by choosing one of the points "No" "0 points", "Very little" "1 point", "A little" "2 points", "Quite" "3 points", "Too much" "4 points".

    Two weeks

Secondary Outcomes (1)

  • Self-Care Needs Evaluation Form

    Two weeks

Study Arms (2)

INTERFERENCE (EXPERIMENT)

EXPERIMENTAL

1. Giving patients with colorectal cancer about 20-30 minutes of training during chemotherapy with the mobile health application and answering face-to-face questions about the use of mobile health application. 2. Sending a reminder message about the use of mobile health application via phone once a week. Answering the questions about the mobile health application and the training given during the chemotherapy application every two weeks / summarizing the training

Other: Colorectal-Mobile application

CONTROL

NO INTERVENTION

1. Giving approximately 20-30 minutes of routine treatment and care and answering questions during premedication application to colorectal cancer patients when they come to the unit to receive 1st cure chemotherapy. 2. Pre-test-post-test at the beginning of the 1st course of treatment and at the end of the 3rd cycle of treatment

Interventions

The use of Colorectal-Mobile application by the patients on a daily basis by the researcher will be monitored remotely via the management platform of the usage status of the mobile health application.

INTERFERENCE (EXPERIMENT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chemotherapy was started with the diagnosis of colorectal cancer,
  • Receiving adjuvant chemotherapy,
  • His psychological and general condition is suitable for the interview and
  • Identified as colorectal cancer patients who volunteered to participate in the study

You may not qualify if:

  • Not diagnosed with colorectal cancer
  • Not diagnosed adjuvant chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykent University

Istanbul, Buyukcekmece, 34528, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal NeoplasmsCell Phone Use

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCommunicationBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 14, 2023

First Posted

July 11, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

January 14, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations