Efficacy of a Web-based Tailored Self-management Program

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Web-based Health Planner on diet and exercise; Behavioral: Non-tailored booklet on exercise and diet

• Registration Number: NCT01512069
• Lead Sponsor: National Cancer Center, Korea

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:

1. 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.

2. 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.

3. The intervention group will show a higher proportion of attaining goal of diet (or higher level of diet quality) compared to the control group.

4. The intervention group will show a better HRQOL level compared to the control group.

5. The intervention group will show a better self-efficacy level compared to the control group.

6. The intervention group will show a lower fatigue level compared to the control group.

7. The intervention group will show less anxiety compared to the control group.

8. 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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2012-03
• Study Completion: 2012-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

1. Women aged 20 years and older
2. 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
3. Serum platelet ≥ 100,000/mm3
4. Serum hemoglobin ≥ 10g/dl
5. 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)
6. Ability to use internet, and being accessible internet at home
7. Mobile phone user
8. Consent form to participate in the study

Exclusion Criteria

1. Currently receiving any cancer treatment
2. 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
3. Conditions that could interfere with a high vegetable and fruit diet, such as kidney failure or chronic warfarin use
4. Progressive malignant disease or additional primary cancers
5. Infectious condition (body temperature ≥ 37.2℃ or WBC ≥ 11,000mm3)
6. Inability to use computer or internet
7. Visual and motor dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based, Stage-matched Exercise and Diet Planning program	Web-based Health Planner on diet and exercise	The 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	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in numbers of goal behaviors at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Stage of Change at 3 months	Baseline, 1month, 2 month, 3 month after starting the intervention	Stage of motivational readiness for exercise and diet based on the established TTM
Change from baseline in self-efficacy at 3 months	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
Change from baseline in Diet quality at 3 months	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
Change from baseline in psychosocial outcomes at 3 months	Baseline, 1month, 2 month, 3 month after starting the intervention	The psychosocial outcomes are HRQOL, fatigue, anxiety and depression

Trial Locations

Locations (4)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Cancer Center; 🇰🇷 Gyenggi-do, Goyang-si, Korea, Republic of