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Completed

NCT Number: NCT01512069

Efficacy of a Web-based Tailored Self-management Program

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center, Gyenggi-do, Goyang-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 20 years and older
  • 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
  • Serum platelet ≥ 100,000/mm3
  • Serum hemoglobin ≥ 10g/dl
  • 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)
  • Ability to use internet, and being accessible internet at home
  • Mobile phone user
  • Consent form to participate in the study

Exclusion criteria

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

Treatment and study plan

Web-based Health Planner on diet and exercise

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.

Other names: English name: Health Planner, Korean name: 건강플래너

Non-tailored booklet on exercise and diet

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.

Primary outcomes

  1. Change from baseline in numbers of goal behaviors at 3 months

    Time frame: 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 outcomes

  1. Change from baseline in Stage of Change at 3 months

    Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention

    Stage of motivational readiness for exercise and diet based on the established TTM

  2. Change from baseline in self-efficacy at 3 months

    Time frame: 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

  3. Change from baseline in psychosocial outcomes at 3 months

    Time frame: Baseline, 1month, 2 month, 3 month after starting the intervention

    The psychosocial outcomes are HRQOL, fatigue, anxiety and depression

  4. Change from baseline in Diet quality at 3 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Asan Medical Center
  • Korea University Anam Hospital
  • Seoul National University

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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