Cancer-related FatiguePhase 2NCT01228773
The Efficacy of Health Navigation® for Cancer-Related Fatigue in Cancer Survivors
A Phase 2 study testing Tailored web-based care program (Health Navigation®) in people with Cancer-related Fatigue, run by National Cancer Center, Korea at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- Tailored web-based care program (Health Navigation®)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Web-based, Tailored Program(Health Navigation®) for the Management of Cancer-Related Fatigue in Cancer Survivors
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
Read the detailed 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.
- Conditions
- Cancer-related Fatigue
- Being tested
- Tailored web-based care program (Health Navigation®)
- Keywords
- Cancer Survivors, Fatigue, web-based, tailored program
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored web-based care program (Health Navigation®)Behavioural
Also called Non-tailored usual care service
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Tailored web-based care program (Health Navigation®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of fatigue Severity
BFI and FSS
Measured: 24 weeks
Secondary outcomes (3)
Mean scores of symptom scores
Measured: 24 weeks
Scores of EORTC QLQ-C30
Measured: 24 weeks
stage of readiness
stage of readiness(physical activity, nutrition, sleep hygiene, distress, pain control, energy conservation)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Korea University Anam Hospital
- Investigators
- Youngho Yun, Ph.D, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228773
- Sponsor's protocol ID
- NCC-YoungHo
- Status last verified
- Jun 2009
- First submitted
- 21 Apr 2010
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cella D, Davis K, Breitbart W, Curt G; Fatigue Coalition. Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001 Jul 15;19(14):3385-91. doi: 10.1200/JCO.2001.19.14.3385.
PubMed 11454886Nieboer P, Buijs C, Rodenhuis S, Seynaeve C, Beex LV, van der Wall E, Richel DJ, Nooij MA, Voest EE, Hupperets P, Mulder NH, van der Graaf WT, TenVergert EM, van Tinteren H, de Vries EG. Fatigue and relating factors in high-risk breast cancer patients treated with adjuvant standard or high-dose chemotherapy: a longitudinal study. J Clin Oncol. 2005 Nov 20;23(33):8296-304. doi: 10.1200/JCO.2005.10.167. Epub 2005 Oct 11.
PubMed 16219926Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
PubMed 10673515Servaes P, Verhagen S, Bleijenberg G. Determinants of chronic fatigue in disease-free breast cancer patients: a cross-sectional study. Ann Oncol. 2002 Apr;13(4):589-98. doi: 10.1093/annonc/mdf082.
PubMed 12056710Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
PubMed 16400678Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
PubMed 11040270Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Reid LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom management in cancer: pain, depression, and fatigue, July 15-17, 2002. J Natl Cancer Inst Monogr. 2004;(32):9-16. doi: 10.1093/jncimonographs/djg014.
PubMed 15263035Groopman JE. Fatigue in cancer and HIV/AIDS. Oncology (Williston Park). 1998 Mar;12(3):335-44; discussion 345-6, 351.
PubMed 9534184Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997 Jul;34(3 Suppl 2):4-12.
PubMed 9253778Ryan JL, Carroll JK, Ryan EP, Mustian KM, Fiscella K, Morrow GR. Mechanisms of cancer-related fatigue. Oncologist. 2007;12 Suppl 1:22-34. doi: 10.1634/theoncologist.12-S1-22.
PubMed 17573453Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093.
PubMed 12721239Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658.
PubMed 12748973Daley AJ, Crank H, Saxton JM, Mutrie N, Coleman R, Roalfe A. Randomized trial of exercise therapy in women treated for breast cancer. J Clin Oncol. 2007 May 1;25(13):1713-21. doi: 10.1200/JCO.2006.09.5083.
PubMed 17470863Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.
PubMed 17557948Dimeo F, Schwartz S, Wesel N, Voigt A, Thiel E. Effects of an endurance and resistance exercise program on persistent cancer-related fatigue after treatment. Ann Oncol. 2008 Aug;19(8):1495-1499. doi: 10.1093/annonc/mdn068. Epub 2008 Apr 1.
PubMed 18381369
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Web-based, Tailored Program(Health Navigation®) for the Management of Cancer-Related Fatigue in Cancer Survivors
- ClinicalTrials.gov ID
- NCT01228773
- Acronym / sponsor ID
- NCC-YoungHo
- Conditions
- Cancer-related Fatigue
- Keywords
- Cancer Survivors, Fatigue, web-based, tailored program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Korea University Anam Hospital
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 27 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Tailored web-based care program (Health Navigation®)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. |
| B | Other | Behavioral: Tailored web-based care program (Health Navigation®)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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored web-based care program (Health Navigation®)Also: Non-tailored usual care serviceWhen 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. | Behavioural | A, B |
Primary outcome
Score of fatigue Severity
Time frame: 24 weeks
BFI and FSS
3 secondary outcomes
Mean scores of symptom scores
Time frame: 24 weeks
Scores of EORTC QLQ-C30
Time frame: 24 weeks
stage of readiness
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
- Results publication: PubMed 11454886Cella D, Davis K, Breitbart W, Curt G; Fatigue Coalition. Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001 Jul 15;19(14):3385-91. doi: 10.1200/JCO.2001.19.14.3385.
- Results publication: PubMed 16219926Nieboer P, Buijs C, Rodenhuis S, Seynaeve C, Beex LV, van der Wall E, Richel DJ, Nooij MA, Voest EE, Hupperets P, Mulder NH, van der Graaf WT, TenVergert EM, van Tinteren H, de Vries EG. Fatigue and relating factors in high-risk breast cancer patients treated with adjuvant standard or high-dose chemotherapy: a longitudinal study. J Clin Oncol. 2005 Nov 20;23(33):8296-304. doi: 10.1200/JCO.2005.10.167. Epub 2005 Oct 11.
- Results publication: PubMed 10673515Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743.
- Results publication: PubMed 12056710Servaes P, Verhagen S, Bleijenberg G. Determinants of chronic fatigue in disease-free breast cancer patients: a cross-sectional study. Ann Oncol. 2002 Apr;13(4):589-98. doi: 10.1093/annonc/mdf082.
- Results publication: PubMed 16400678Bower JE, Ganz PA, Desmond KA, Bernaards C, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in long-term breast carcinoma survivors: a longitudinal investigation. Cancer. 2006 Feb 15;106(4):751-8. doi: 10.1002/cncr.21671.
- Results publication: PubMed 11040270Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
- Results publication: PubMed 15263035Patrick DL, Ferketich SL, Frame PS, Harris JJ, Hendricks CB, Levin B, Link MP, Lustig C, McLaughlin J, Reid LD, Turrisi AT 3rd, Unutzer J, Vernon SW; National Institutes of Health State-of-the-Science Panel. National Institutes of Health State-of-the-Science Conference Statement: Symptom management in cancer: pain, depression, and fatigue, July 15-17, 2002. J Natl Cancer Inst Monogr. 2004;(32):9-16. doi: 10.1093/jncimonographs/djg014.
- Results publication: PubMed 9534184Groopman JE. Fatigue in cancer and HIV/AIDS. Oncology (Williston Park). 1998 Mar;12(3):335-44; discussion 345-6, 351.
- Results publication: PubMed 9253778Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997 Jul;34(3 Suppl 2):4-12.
- Results publication: PubMed 17573453Ryan JL, Carroll JK, Ryan EP, Mustian KM, Fiscella K, Morrow GR. Mechanisms of cancer-related fatigue. Oncologist. 2007;12 Suppl 1:22-34. doi: 10.1634/theoncologist.12-S1-22.
- Results publication: PubMed 12721239Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093.
- Results publication: PubMed 12748973Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngho Yun, Ph.D principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tailored web-based care program (Health Navigation®) in people with Cancer-related Fatigue, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of fatigue Severity (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228773, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2010.