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

Cancer-related Fatigue Clinical Trial

Official title:

The Efficacy of Web-based, Tailored Program(Health Navigation®) for the Management of Cancer-Related Fatigue in Cancer Survivors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01228773
• Other study ID #: NCC-YoungHo
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: April 21, 2010
• Last updated: October 26, 2010
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2009
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

*** Background

Cancer-related fatigue (CRF) and its impact on patients' quality of life has been increasing subject of research. Especially, cancer survivors who are complaining of fatigue (moderate - severe) should be cared.

Multidimensional characteristics of CRF were addressed in the NCCN guideline for CRF, and NCCN guideline points out the importance of behavioral approaches in managing of CRF.

NCCN guideline in 2008 suggests that 6 strategic areas (1) Energy Conservation, 2) Pain 3) Sleep disturbance 4) Distress 5) exercise, 6) Nutrition) are important issues in caring CRF in addition to the medical treatment caring chronic disease or co morbidity.

Behavioral strategy can lead those 6 areas to be effective.

However, to our knowledge, no study has examined the comprehensive fatigue management program.

The objective of this study is to develop the Web based, tailored program(Health Navigation®) for disease-free cancer patients to cope with CRF, and then evaluate the efficacy of the Web-based program(Health Navigation®).

From evidence extracted from a literature review, contents of the program was elaborated, and tailored from the TTM model. The curriculum is currently being reviewed and validated by an expert group of palliative care physician, oncologists, nurse, psychologist and health education scientists. The module will be pretested with a small number of patients, discussed in terms of feasibility and acceptance.

*** Method

To determine the efficacy of the program(Health Navigation®), a randomized controlled trial will be conducted:

After excluding patients with other causes (anemia, thyroid diseases, liver disease, co morbidities etc), 296 patients will be recruited based on statistical assumption of alpha (0.05), beta (0.20=power 80%), effect size (0.375) and drop out rate (10%).

First, they will be stratified according to their age (<50 vs. >50) and sex (male vs. female), cancer type (type 1: stomach cancer & colon cancer, type 2: Cervix & Breast cancer & Thyroid, type 3 : Lung cancer ), cancer stage (I-III) ; and then allocated to an intervention or a wait-list control group.

When intervention group participate in the Web-based care program (Health Navigation®), they can receive various information which is related with the CRF.

And 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.

Their assistants (family member or friend) help them change their behaviors. Wait-list (control) group could not participate in the fatigue-care program (based on the Web based care program: Health Navigation®).

They could only be treated by usual care and use internet for health information. However, they can participate in the fatigue care program (Health Navigation®) after 12 weeks.

Data will be collected before randomization, after intervention, and after a follow-up of 6 months.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 266
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si, Gyeonggi-do

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Korea University Anam Hospital, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of fatigue Severity	BFI and FSS	24 weeks	No
Secondary	Mean scores of symptom scores		24 weeks	No
Secondary	Scores of EORTC QLQ-C30		24 weeks	No
Secondary	stage of readiness	stage of readiness(physical activity, nutrition, sleep hygiene, distress, pain control, energy conservation)	24 weeks	No