Efficacy of a Web-based Tailored Self-management Program

National Cancer Center (NCC)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Non-tailored booklet on exercise and diet; Behavioral: Web-based Health Planner on diet and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01512069

NCCNCS-11-501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Web-based, Stage-matched Exercise and Diet Planning program

Experimental group

Description:

The experimental arm is a group that assigned to use web-based, stage-matched exercise and diet planning program.

Treatment:

Behavioral: Web-based Health Planner on diet and exercise

Non-tailored booklet on exercise and diet

Active Comparator group

Description:

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.

Treatment:

Behavioral: Non-tailored booklet on exercise and diet