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

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ClinicalTrials.gov Identifier: NCT01228773
Recruitment Status : Unknown
Verified June 2009 by National Cancer Center, Korea.
Recruitment status was:  Enrolling by invitation
First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Information provided by:
National Cancer Center, Korea

Brief Summary:

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 or disease Intervention/treatment Phase
Cancer-related Fatigue Behavioral: Tailored web-based care program (Health Navigation®) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Score of fatigue Severity [ Time Frame: 24 weeks ]
    BFI and FSS


Secondary Outcome Measures :
  1. Mean scores of symptom scores [ Time Frame: 24 weeks ]
  2. Scores of EORTC QLQ-C30 [ Time Frame: 24 weeks ]
  3. stage of readiness [ Time Frame: 24 weeks ]
    stage of readiness(physical activity, nutrition, sleep hygiene, distress, pain control, energy conservation)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:

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
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: June 2009

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

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms