The Efficacy of Health Navigation® for Cancer-Related Fatigue in Cancer Survivors
This study is enrolling participants by invitation only.
Sponsor:
National Cancer Center, Korea
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
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Purpose
The objective of this study is
- to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors, which is comprehensive and evidence-based,
- to evaluate the efficacy for cancer-related fatigue as a result of participating in the Web based, tailored program(Health Navigation®) for 12 weeks
- 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
- 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 May 16, 2013