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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


N/A
20 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change from baseline in numbers of goal behaviors at 3 months

Outcome Description:

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.

Outcome Time Frame:

Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment)

Safety Issue:

Yes

Principal Investigator

YoungSung Lee, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center

Authority:

Korea: Food and Drug Administration

Study ID:

NCCNCS-11-501

NCT ID:

NCT01512069

Start Date:

October 2011

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • randomized controlled trial
  • internet
  • diet
  • exercise
  • health planning
  • the TTM
  • Breast Neoplasms

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