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

NCT01228773 | Unknown Phase 2 DMC

• 1 other identifier: NCC-YoungHo
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is

1. 1.to develop a web-based, tailored program for Cancer-related fatigue in cancer survivors, which is comprehensive and evidence-based,
2. 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. 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. 4.to assess the efficacy of such intervention compared with usual care in cancer survivors

Conditions

Cancer-related Fatigue

Keywords

Cancer Survivors, Fatigue, web-based, tailored program

Outcome Measures

Primary Outcomes (1)

• Score of fatigue Severity

  BFI and FSS

  24 weeks

Secondary Outcomes (3)

• Mean scores of symptom scores

  24 weeks

• Scores of EORTC QLQ-C30

  24 weeks

• stage of readiness

  24 weeks

Study Arms (2)

A

EXPERIMENTAL

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®)

B

OTHER

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®)

Interventions

Tailored web-based care program (Health Navigation®) BEHAVIORAL

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.

Also known as: Non-tailored usual care service

A; B

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Korea University Anam Hospital: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Location

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MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Youngho Yun, Ph.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: October 27, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 27, 2010

Record last verified: 2009-06

Locations

KR (1)