Efficacy of a Web-based Tailored Self-management Program
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Web-based Health Planner on diet and exercise
Non-tailored booklet on exercise and diet
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring randomized controlled trial, internet, diet, exercise, health planning, the TTM
Eligibility Criteria
Inclusion Criteria:
- Women aged 20 years and older
- Histologically confirmed stage 0 to III breast cancer who received curative breast cancer surgery within 12 months since completion of primary cancer treatment and 2 years since diagnosis
- Serum platelet ≥ 100,000/mm3
- Serum hemoglobin ≥ 10g/dl
- Not met one or more behavior goals: i) energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week; ii) intake of vegetables except kimchi ≥ 5 serv/day and intake of fruit 1-2 serv/day; iii) maintenance of healthy weight (18.5 kg/m2 ≤ BMI < 23 kg/m2)
- Ability to use internet, and being accessible internet at home
- Mobile phone user
- Consent form to participate in the study
Exclusion Criteria:
- Currently receiving any cancer treatment
- Conditions that could limit adherence to an unsupervised exercise program such as uncontrolled congestive heart failure or angina, recent myocardial infarction, or breathing difficulties requiring oxygen use or hospitalization; walker or wheelchair use; or plans to have hip or knee replacement
- Conditions that could interfere with a high vegetable and fruit diet, such as kidney failure or chronic warfarin use
- Progressive malignant disease or additional primary cancers
- Infectious condition (body temperature ≥ 37.2℃ or WBC ≥ 11,000mm3)
- Inability to use computer or internet
- Visual and motor dysfunction
Sites / Locations
- National Cancer Center
- Asan Medical Center
- Korea University Anam Hospital
- Seoul National University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Web-based, Stage-matched Exercise and Diet Planning program
Non-tailored booklet on exercise and diet
Arm Description
The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program.
The control group is provided a booklet containing same information on exercise and diet as in the experimental group's web-based program, but the information on a booklet is not tailored to participants' stage of motivational readiness for exercise and diet based on the TTM.
Outcomes
Primary Outcome Measures
Change from baseline in numbers of goal behaviors at 3 months
The primary outcomes of the study are to achieve goals of healthy behaviors as followed:
i) exercising≥12.5kcal/kg/week; ii) eating vegetables≥5serv/day and fruits 1-2 serv/day; iii) healthy weight (18.5kg/m2 ≤ BMI < 25kg/m2) The primary outcome of the study is the increased number of goal behaviors.
Secondary Outcome Measures
Change from baseline in Stage of Change at 3 months
Stage of motivational readiness for exercise and diet based on the established TTM
Change from baseline in self-efficacy at 3 months
The self-efficacy for exercising≥12.5kcal/kg/week, eating vegetables≥5serv/day and fruits 1-2 serv/day
Change from baseline in psychosocial outcomes at 3 months
The psychosocial outcomes are HRQOL, fatigue, anxiety and depression
Change from baseline in Diet quality at 3 months
Diet quality based on a three-day diet recall and the Diet Quality Index (DQI) revised for the Korean population
Full Information
NCT ID
NCT01512069
First Posted
January 4, 2012
Last Updated
April 23, 2014
Sponsor
National Cancer Center, Korea
Collaborators
Seoul National University, Asan Medical Center, Korea University Anam Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01512069
Brief Title
Efficacy of a Web-based Tailored Self-management Program
Official Title
Efficacy of a Web-based Self-management Exercise and Diet Intervention Program With Tailored Motivation and Action Planning for Breast Cancer Survivors: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Seoul National University, Asan Medical Center, Korea University Anam Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Life style interventions that promote exercise and a healthy diet, which have the potential to improve health-related quality of life (HRQOL), may be particularly appropriate for cancer survivors. The previous studies suggested that a key strategy to implement sustainable healthy behavior and improve health was providing appropriate feedback and promoting self-efficacy. Web-based program enables to provide the feedback in a timely manner on a daily basis, to continue the healthy behaviors.
Therefore, the investigators developed a web-based, stage-matched Exercise and Diet Planning program, and whether the program can promote significantly greater changes in behavioral outcomes [goal of exercise (energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week) and diet (intake of vegetables ≥ 5 serv/day and intake of fruit ≥ 1 serv/day)], stage of changes for exercise and diet, psychosocial outcomes (HRQOL, fatigue, anxiety and depression) and self-efficacy in implementing goal of exercise and diet among breast cancer survivors in Korea was examined.
Hypotheses were following:
Survivors of a group participating in a web-based, stage-matched Exercise and Diet Planning program (hereinafter called the 'intervention group') will show a more advanced stage of change for exercise and diet compared to survivors in the control group.
The intervention group will show a higher proportion of attaining goal of exercise (or higher level of energy expenditure of aerobic exercise) compared to the control group.
The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.
The intervention group will show a better HRQOL level compared to the control group.
The intervention group will show a better self-efficacy level compared to the control group.
The intervention group will show a lower fatigue level compared to the control group.
The intervention group will show less anxiety compared to the control group.
The intervention group will show less depression compared to the control group.
Detailed Description
The purpose of the study was to develop a web-based, stage-matched Exercise and Diet Planning program and to examine effects of the program on implementation of exercise and diet, self-efficacy, HRQOL, fatigue, anxiety and depression among breast cancer survivors.
All participants were recruited from two tertiary university hospitals and the National Cancer Center in Korea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
randomized controlled trial, internet, diet, exercise, health planning, the TTM
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based, Stage-matched Exercise and Diet Planning program
Arm Type
Experimental
Arm Description
The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program.
Arm Title
Non-tailored booklet on exercise and diet
Arm Type
Active Comparator
Arm Description
The control group is provided a booklet containing same information on exercise and diet as in the experimental group's web-based program, but the information on a booklet is not tailored to participants' stage of motivational readiness for exercise and diet based on the TTM.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Health Planner on diet and exercise
Other Intervention Name(s)
English name: Health Planner, Korean name: 건강플래너
Intervention Description
URL is closed
The program is 12-week program, provides tailored information on the exercise and diet based on the stage of motivational readiness of TTM. The program is designed to allow to plan a regular exercise of 12.5 MET per week and to recommend to eat number of portions from six food groups for balanced diet tailored to individual's BMI, ideal body weight, and calories needed per day. The program provide the feedback based on the achievement of goals of the behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Non-tailored booklet on exercise and diet
Intervention Description
The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.
Primary Outcome Measure Information:
Title
Change from baseline in numbers of goal behaviors at 3 months
Description
The primary outcomes of the study are to achieve goals of healthy behaviors as followed:
i) exercising≥12.5kcal/kg/week; ii) eating vegetables≥5serv/day and fruits 1-2 serv/day; iii) healthy weight (18.5kg/m2 ≤ BMI < 25kg/m2) The primary outcome of the study is the increased number of goal behaviors.
Time Frame
Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
Secondary Outcome Measure Information:
Title
Change from baseline in Stage of Change at 3 months
Description
Stage of motivational readiness for exercise and diet based on the established TTM
Time Frame
Baseline, 1month, 2 month, 3 month after starting the intervention
Title
Change from baseline in self-efficacy at 3 months
Description
The self-efficacy for exercising≥12.5kcal/kg/week, eating vegetables≥5serv/day and fruits 1-2 serv/day
Time Frame
Baseline, 1month, 2 month, 3 month after starting the intervention
Title
Change from baseline in psychosocial outcomes at 3 months
Description
The psychosocial outcomes are HRQOL, fatigue, anxiety and depression
Time Frame
Baseline, 1month, 2 month, 3 month after starting the intervention
Title
Change from baseline in Diet quality at 3 months
Description
Diet quality based on a three-day diet recall and the Diet Quality Index (DQI) revised for the Korean population
Time Frame
Baseline, 1month, 2 month, 3 month after starting the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women aged 20 years and older
Histologically confirmed stage 0 to III breast cancer who received curative breast cancer surgery within 12 months since completion of primary cancer treatment and 2 years since diagnosis
Serum platelet ≥ 100,000/mm3
Serum hemoglobin ≥ 10g/dl
Not met one or more behavior goals: i) energy expenditure of aerobic exercise ≥ 12.5 kcal/kg/week; ii) intake of vegetables except kimchi ≥ 5 serv/day and intake of fruit 1-2 serv/day; iii) maintenance of healthy weight (18.5 kg/m2 ≤ BMI < 23 kg/m2)
Ability to use internet, and being accessible internet at home
Mobile phone user
Consent form to participate in the study
Exclusion Criteria:
Currently receiving any cancer treatment
Conditions that could limit adherence to an unsupervised exercise program such as uncontrolled congestive heart failure or angina, recent myocardial infarction, or breathing difficulties requiring oxygen use or hospitalization; walker or wheelchair use; or plans to have hip or knee replacement
Conditions that could interfere with a high vegetable and fruit diet, such as kidney failure or chronic warfarin use
Progressive malignant disease or additional primary cancers
Infectious condition (body temperature ≥ 37.2℃ or WBC ≥ 11,000mm3)
Inability to use computer or internet
Visual and motor dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YoungSung Lee, PhD
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Gyenggi-do
State/Province
Goyang-si
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24856854
Citation
Lee MK, Yun YH, Park HA, Lee ES, Jung KH, Noh DY. A Web-based self-management exercise and diet intervention for breast cancer survivors: pilot randomized controlled trial. Int J Nurs Stud. 2014 Dec;51(12):1557-67. doi: 10.1016/j.ijnurstu.2014.04.012. Epub 2014 May 1.
Results Reference
derived
Learn more about this trial
Efficacy of a Web-based Tailored Self-management Program
We'll reach out to this number within 24 hrs