Clinical trial NCT01512069: Efficacy of a Web-based Tailored Self-management Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: randomized controlled trial
internet
diet
exercise
health planning
the TTM
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University
name: Asan Medical Center
name: Korea University Anam Hospital
First posted: 2012-01-19
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in numbers of goal behaviors at 3 months
timeFrame: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)
Secondary outcomes:
measure: Change from baseline in Stage of Change at 3 months
timeFrame: Baseline, 1month, 2 month, 3 month after starting the intervention
measure: Change from baseline in self-efficacy at 3 months
timeFrame: Baseline, 1month, 2 month, 3 month after starting the intervention
measure: Change from baseline in psychosocial outcomes at 3 months
timeFrame: Baseline, 1month, 2 month, 3 month after starting the intervention
measure: Change from baseline in Diet quality at 3 months
timeFrame: Baseline, 1month, 2 month, 3 month after starting the intervention
Other outcomes:
Locations:
city: Gyenggi-do
country: Korea, Republic of
facility: National Cancer Center
state: Goyang-si
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: National Cancer Center
name: YoungSung Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.