Efficacy of a Web-based Tailored Self-management Program

This study has been completed.
Sponsor:
Collaborators:
Seoul National University
Asan Medical Center
Korea University Anam Hospital
Information provided by (Responsible Party):
YoungSung Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01512069
First received: January 4, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.

Condition Intervention
Breast Cancer
Behavioral: Web-based Health Planner on diet and exercise
Behavioral: Non-tailored booklet on exercise and diet

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

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Change from baseline in numbers of goal behaviors at 3 months [ Time Frame: Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment) ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Change from baseline in Stage of Change at 3 months [ Time Frame: Baseline, 1month, 2 month, 3 month after starting the intervention ] [ Designated as safety issue: Yes ]
    Stage of motivational readiness for exercise and diet based on the established TTM

  • Change from baseline in self-efficacy at 3 months [ Time Frame: Baseline, 1month, 2 month, 3 month after starting the intervention ] [ Designated as safety issue: Yes ]
    The self-efficacy for exercising≥12.5kcal/kg/week, eating vegetables≥5serv/day and fruits 1-2 serv/day

  • Change from baseline in psychosocial outcomes at 3 months [ Time Frame: Baseline, 1month, 2 month, 3 month after starting the intervention ] [ Designated as safety issue: Yes ]
    The psychosocial outcomes are HRQOL, fatigue, anxiety and depression

  • Change from baseline in Diet quality at 3 months [ Time Frame: Baseline, 1month, 2 month, 3 month after starting the intervention ] [ Designated as safety issue: Yes ]
    Diet quality based on a three-day diet recall and the Diet Quality Index (DQI) revised for the Korean population


Enrollment: 59
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

Other Names:
  • English name: Health Planner
  • Korean name: 건강플래너
Active Comparator: 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.
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.

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512069

Locations
Korea, Republic of
National Cancer Center
Gyenggi-do, Goyang-si, Korea, Republic of, 410-769
Seoul National University
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Seoul National University
Asan Medical Center
Korea University Anam Hospital
Investigators
Principal Investigator: YoungSung Lee, PhD National Cancer Center
  More Information

No publications provided

Responsible Party: YoungSung Lee, Head, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01512069     History of Changes
Other Study ID Numbers: NCCNCS-11-501
Study First Received: January 4, 2012
Last Updated: April 23, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
randomized controlled trial
internet
diet
exercise
health planning
the TTM

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014