Efficacy of a Web-based Tailored Self-management Program

NCT ID: NCT01512069

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-08-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Web-based Health Planner on diet and exercise

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Non-tailored booklet on exercise and diet

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

English name: Health Planner; Korean name: 건강플래너

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

YoungSung Lee

Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YoungSung Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Gyenggi-do, Goyang-si, South Korea

Asan Medical Center

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24856854 (View on PubMed)

Other Identifiers

NCCNCS-11-501

Identifier Type: -

Identifier Source: org_study_id