Efficacy of a Web-based Tailored Self-management Program

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512069
• Other study ID #: NCCNCS-11-501
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: April 23, 2014
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Web-based Health Planner on diet and exercise
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 diet
The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Gyenggi-do	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Asan Medical Center, Korea University Anam Hospital, Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)	Yes
Secondary	Change from baseline in Stage of Change at 3 months	Stage of motivational readiness for exercise and diet based on the established TTM	Baseline, 1month, 2 month, 3 month after starting the intervention	Yes
Secondary	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	Baseline, 1month, 2 month, 3 month after starting the intervention	Yes
Secondary	Change from baseline in psychosocial outcomes at 3 months	The psychosocial outcomes are HRQOL, fatigue, anxiety and depression	Baseline, 1month, 2 month, 3 month after starting the intervention	Yes
Secondary	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	Baseline, 1month, 2 month, 3 month after starting the intervention	Yes