The Efficacy of Health Navigation® for Cancer-Related Fatigue in Cancer Survivors

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01228773
First received: April 21, 2010
Last updated: October 26, 2010
Last verified: June 2009
  Purpose

The objective of this study is

  1. to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors, which is comprehensive and evidence-based,
  2. to evaluate the efficacy for cancer-related fatigue as a result of participating in the Web based, tailored program(Health Navigation®) for 12 weeks
  3. to evaluate the efficacy for quality of life, fatigue-related behavior, satisfaction with the treatment as a result of participating in the Web based, tailored program(health navigation®) for 12 weeks
  4. to assess the efficacy of such intervention compared with usual care in cancer survivors

Condition Intervention Phase
Cancer-related Fatigue
Behavioral: Tailored web-based care program (Health Navigation®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Web-based, Tailored Program(Health Navigation®) for the Management of Cancer-Related Fatigue in Cancer Survivors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Score of fatigue Severity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    BFI and FSS


Secondary Outcome Measures:
  • Mean scores of symptom scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Scores of EORTC QLQ-C30 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • stage of readiness [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    stage of readiness(physical activity, nutrition, sleep hygiene, distress, pain control, energy conservation)


Estimated Enrollment: 266
Study Start Date: July 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

Providing tailored web-based care program(Health Navigation®), which provides various information related to the CRF.

Web-based fatigue care program consists of 6 strategic areas (energy conservation, nutrition, exercise, sleep disturbance, pain, and distress); three areas (pain, exercise, sleep disturbance) are based on the transtheoretical model (TTM), and others (energy conservation, distress, nutrition) are based on psycho-education method or cognitive behavioral therapy. Cancer survivors who participate in the Web-based care program (Health Navigation®) will be received tailored EMS/SMS message that notify participants of the next program's news and the last program's issue etc.

Behavioral: Tailored web-based care program (Health Navigation®)
When intervention group participate in the Web-based care program (Health Navigation®), they can receive various information which is related with the CRF. Web-based fatigue care program consists of 6 strategic areas (energy conservation, nutrition, exercise, sleep disturbance, pain, and distress); three areas (pain, exercise, sleep disturbance) are based on the transtheoretical model (TTM), and others (energy conservation, distress, nutrition) are based on psycho-education method or cognitive behavioral therapy. Cancer survivors who participate in the Web-based care program (Health Navigation®) will be received tailored EMS/SMS message that notify participants of the next program's news and the last program's issue.
Other Name: Non-tailored usual care service
B
Attention control arm: Providing usual care for CRF. Three months later, as attention control, they will be provided tailored web-based care program(Health Navigation®), which provides various information related to the CRF.
Behavioral: Tailored web-based care program (Health Navigation®)
When intervention group participate in the Web-based care program (Health Navigation®), they can receive various information which is related with the CRF. Web-based fatigue care program consists of 6 strategic areas (energy conservation, nutrition, exercise, sleep disturbance, pain, and distress); three areas (pain, exercise, sleep disturbance) are based on the transtheoretical model (TTM), and others (energy conservation, distress, nutrition) are based on psycho-education method or cognitive behavioral therapy. Cancer survivors who participate in the Web-based care program (Health Navigation®) will be received tailored EMS/SMS message that notify participants of the next program's news and the last program's issue.
Other Name: Non-tailored usual care service

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (≥20, ≤65)
  • moderate to severe fatigue (fatigue VAS ≥4), which persists at least 1 week in the Average Fatigue or the the Worst Fatigue
  • Stage I-III
  • Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy)
  • Cancer survivors who are familiar with the high-speed internet and mobile phone, or cancer survivors who can participate in the web-based program with their supporter's assistance.

Exclusion Criteria:

  • patients undergoing or planning surgery, radiation therapy or chemotherapy
  • Major health problem which might cause fatigue or in which exercise/nutrition intervention is contraindicated at the discretion of clinician; from PAR-Q and ACSM test, cardiovascular disease(congestive heart failure, angina), pulmonary disease(chronic obstructive pulmonary disease, restrictive pulmonary disease), uncontrolled hypertension, poorly controlled diabetes and severe musculoskeletal disease and so on
  • Sign of infection (body temperature ≥ 37.2℃, WBC≥11,000)
  • Thrombocytopenia (platelet count ≤ 100,000/mcl)
  • Anemia (Hb ≤ 10g/dL)
  • SGOT or SGPT > 40 IU/L
  • Creatinine > 1.4 mg/dL
  • severe psychiatric disorders (psychotic disorder, major depression and so on) or suicidal tendencies
  • dyspnea
  • evidence of metastasis and recurrence
  • ECOG(Eastern Cooperative Oncology Group) performance status of 3-4
  • Not Korean speaking
  • Not understanding of the study purpose and not written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228773

Locations
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Samsung Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Investigators
Principal Investigator: Youngho Yun, Ph.D National Cancer Center
  More Information

Publications:

Responsible Party: Young Ho Yun. M.D., Ph.D. /Hospice & Palliative care branch, National Cancer Center
ClinicalTrials.gov Identifier: NCT01228773     History of Changes
Other Study ID Numbers: NCC-YoungHo
Study First Received: April 21, 2010
Last Updated: October 26, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
Cancer Survivors, Fatigue, web-based, tailored program

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014