Breast CancerNCT01512069
Efficacy of a Web-based Tailored Self-management Program
A study testing Web-based Health Planner on diet and exercise and Non-tailored booklet on exercise and diet in people with Breast Cancer, run by National Cancer Center, Korea at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Web-based Health Planner on diet and exercise and Non-tailored booklet on exercise and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Oct 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
National Cancer Center
Gyenggi-do, Goyang-si, 410-769
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Seoul National University
Seoul
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Web-based Health Planner on diet and exercise, Non-tailored booklet on exercise and diet
- Keywords
- randomized controlled trial, internet, diet, exercise, health planning, the TTM
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Health Planner on diet and exerciseBehavioural
Also called English name: Health Planner, Korean name: 건강플래너
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.
Non-tailored booklet on exercise and dietBehavioural
The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.
| Study group | Role | What they receive |
|---|---|---|
| Web-based, Stage-matched Exercise and Diet Planning program | Experimental | The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program. Receives: Behavioral: Web-based Health Planner on diet and exercise |
| Non-tailored booklet on exercise and diet | Active comparator | 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. Receives: Behavioral: Non-tailored booklet on exercise and diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
Measured: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
Secondary outcomes (4)
Change from baseline in Stage of Change at 3 months
Stage of motivational readiness for exercise and diet based on the established TTM
Measured: Baseline, 1month, 2 month, 3 month after starting the intervention
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
Measured: Baseline, 1month, 2 month, 3 month after starting the intervention
Change from baseline in psychosocial outcomes at 3 months
The psychosocial outcomes are HRQOL, fatigue, anxiety and depression
Measured: Baseline, 1month, 2 month, 3 month after starting the intervention
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
Measured: Baseline, 1month, 2 month, 3 month after starting the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul National University, Asan Medical Center, Korea University Anam Hospital
- Responsible party
- Principal investigator, YoungSung Lee, National Cancer Center, Korea
- Investigators
- YoungSung Lee, PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512069
- Sponsor's protocol ID
- NCCNCS-11-501
- Status last verified
- Apr 2014
- First submitted
- 4 Jan 2012
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24856854
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01512069
- Acronym / sponsor ID
- NCCNCS-11-501
- Conditions
- Breast Cancer
- Keywords
- randomized controlled trial, internet, diet, exercise, health planning, the TTM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul National University, Asan Medical Center, Korea University Anam Hospital
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based, Stage-matched Exercise and Diet Planning program | Experimental | Behavioral: Web-based Health Planner on diet and exerciseThe experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program. |
| Non-tailored booklet on exercise and diet | Active comparator | Behavioral: Non-tailored booklet on exercise and dietThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based Health Planner on diet and exerciseAlso: English name: Health Planner, Korean name: 건강플래너URL 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. | Behavioural | Web-based, Stage-matched Exercise and Diet Planning program |
| Non-tailored booklet on exercise and dietThe active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching. | Behavioural | Non-tailored booklet on exercise and diet |
Primary outcome
Change from baseline in numbers of goal behaviors at 3 months
Time frame: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
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.
4 secondary outcomes
Change from baseline in Stage of Change at 3 months
Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention
Change from baseline in self-efficacy at 3 months
Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention
Change from baseline in psychosocial outcomes at 3 months
Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention
Change from baseline in Diet quality at 3 months
Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 24856854Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YoungSung Lee, PhD principal investigator
National Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based Health Planner on diet and exercise and Non-tailored booklet on exercise and diet in people with Breast Cancer, run by National Cancer Center, Korea at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in numbers of goal behaviors at 3 months (time frame: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01512069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014; AzTrials last refreshed its copy on 27 Oct 2026.