- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01512069
Efficacy of a Web-based Tailored Self-management Program
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Asan Medical Center
-
Seoul, Korea, Republic of
- Korea University Anam Hospital
-
Seoul, Korea, Republic of
- Seoul National University
-
-
Goyang-si
-
Gyenggi-do, Goyang-si, Korea, Republic of, 410-769
- National Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Web-based, Stage-matched Exercise and Diet Planning program
The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program.
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Non-tailored booklet on exercise and diet
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.
|
The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Stage of Change at 3 months
Time Frame: Baseline, 1month, 2 month, 3 month after starting the intervention
|
Stage of motivational readiness for exercise and diet based on the established TTM
|
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
|
The self-efficacy for exercising≥12.5kcal/kg/week,
eating vegetables≥5serv/day and fruits 1-2 serv/day
|
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
|
The psychosocial outcomes are HRQOL, fatigue, anxiety and depression
|
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
|
Diet quality based on a three-day diet recall and the Diet Quality Index (DQI) revised for the Korean population
|
Baseline, 1month, 2 month, 3 month after starting the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: YoungSung Lee, PhD, National Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCNCS-11-501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on Web-based Health Planner on diet and exercise
-
Innovation Research & TrainingCompleted
-
Cumhuriyet UniversityNot yet recruitingFear of Childbirth | Self-efficacyTurkey
-
Cumhuriyet UniversityUnknownExercise | Self Efficacy | Decision MakingTurkey
-
Yuzuncu Yıl UniversityAtaturk UniversityCompletedType2 Diabetes MellitusTurkey
-
Cumhuriyet UniversityRecruitingBariatric Surgery CandidateTurkey
-
McGill UniversityCompleted
-
Umeå UniversityCounty Council of Norrbotten, SwedenCompletedHypertension | Obesity | Type 2 Diabetes | DyslipidemiaSweden
-
Igdir UniversityAtaturk UniversityRecruiting
-
Barbara Jakše s.p.CompletedObesity | Weight Loss
-
University of Alabama at BirminghamNational Cancer Institute (NCI); University of TennesseeActive, not recruitingKidney Cancer | Breast Cancer | Multiple Myeloma | Colorectal Cancer | Prostate Cancer | Non-Hodgkin Lymphoma | Endometrial Cancer | Thyroid Cancer | Ovary CancerUnited States