Non-metastatic Patients With Breast CancerEMOTIONNCT01977053
Impact of a Telephonic Monitoring During Inter-treatment Intervals on Emotional State, Quality of Life and Toxicities, on Neo Adjuvant or Adjuvant Chemotherapy-treated Patients
A study testing Clinical and psychosocial phone calls in people with Non-metastatic Patients With Breast Cancer and Non-metastatic Patients With Colon Cancer, run by Centre Antoine Lacassagne at 2 sites in France.
Trial summary
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-metastatic Patients With Breast Cancer, Non-metastatic Patients With Colon Cancer, Non-metastatic Patients With Rectal Cancer
- What is being tested?
- Clinical and psychosocial phone calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2013to Dec 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18.
- Patient surgically-treated or no for non inflammatory breast cancer or for colon cancer or rectal cancer.
- Patient to be treated by neo-adjuvant or adjuvant chemotherapy by 5-fluorouracil, epirubicin and cyclophosphamide (FEC)-docetaxel, docetaxel-cyclophosphamide, 5-fluorouracil/leucovorin with oxaliplatin(FOLFOX) or XELOX. A treatment with trastuzumab is allowed in association.
- Patient never treated by chemotherapy.
- Patient with Performance Status under or equal to 2.
- Patient with adequate hematopoietic, hepatic and cardiac functions according to the investigator.
- Patient having read with the information note and having signed the informed consent.
- Patient beneficiating from French health insurance cover.
Who cannot join
- Patient with psychological state, geographical remote or social problems that contraindicated the participation into the study according to the investigator.
- Patient that must be treated for a metastatic disease.
- Patient not able to attend all study visits.
- Patient not understanding French.
- Patient who don't have a phone.
- Vulnerable patient: pregnant or breast-feeding women, person deprived of freedom by an administrative or judicial decision, person older than 18 being the object of a legal protection measure or outside state to express their consent.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Polyclinique St Jean
Cagnes-sur-Mer, 06800
Centre Antoine Lacassagne
Nice, Cedex 2, 06189
About this study
Official title: Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.
Read more
The patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and / or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
Read the detailed description
Cancer is widely associated with the concept of psychological distress in a population of patients subject to numerous stressful events. Between 10 to 50% of patients with cancer and their families suffer from clinically significant psychological disorders.
The existence of a broad continuum of manifestations of distress makes it difficult for clinical evaluation. Underestimated and misjudged, it is not always taken into account appropriately. However, these problems have a direct impact not only on the quality of life of patients but also on their ability to share decisions , adhere to treatment, and therefore to get the best care available for the treatment of their cancer.
Interactions between the presence of psychopathological disorders, quality of life and treatment toxicities will be the focus of this study assessing the impact of telephonic monitoring (targeting clinical, psychological and social objectives) in patients with current chemotherapy.
There are communication difficulties on the distress between the patient and the doctor, in part due to the gap between the perceptions of the patient and the caregiver. Indeed, many studies have highlighted the important differences existing between subjective psychosocial needs of the patient and the physician's ability to detect them. In particular, the study of Fallowfield on nearly 2300 medical consultations shows that only 29% of patients whose threshold of distress is clinically significant are identified by their doctors. Similarly, the synthesis carried out in 2005 by Thorne et al. reported the impact of failures of communication between clinicians and patients on the psychosocial experience of illness and treatment, symptom management, decision making and quality of life.
Justification and research hypothesis
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.
The patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and / or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during the first 3 inter-treatment intervals, the overall measure of mood states (anxiety, depression , confusion , anger , fatigue , vigor and interpersonal ) of the patient and his entourage . We also study the gain in quality of life, anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
We propose to determine on a population of 280 patients, the impact of two phone calls during the 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
- Conditions
- Non-metastatic Patients With Breast Cancer, Non-metastatic Patients With Colon Cancer, Non-metastatic Patients With Rectal Cancer, Patients Undergoing Adjuvant Chemotherapy
- Being tested
- Clinical and psychosocial phone calls
- Keywords
- breast cancer, colon cancer, rectal cancer, adjuvant chemotherapy, phone calls, emotional states, quality of life
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and psychosocial phone callsOther
Also called medical care including social and psychological domains
The standard medical supervision is defined as follows:
- Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy.
- Nominative notebook containing details of chemotherapy administered and medical contacts.
- Consultations with psycho-oncologist or psychiatrist (if necessary).
The intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported.
| Study group | Role | What they receive |
|---|---|---|
| A: Standard medical care | No intervention | Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France |
| B: telephonic monitoring | Experimental | Arm B: telephonic monitoring during inter-treatment intervals + personalized medical care. Receives: Other: Clinical and psychosocial phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)
comparison of the 2 types of monitoring in terms of overall measure of emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) of patients, with Profile of Mood States (POMS-f) questionnaire.
Measured: Change from baseline in POMS-f score at 6 weeks
Secondary outcomes (7)
Evolution of emotional states scores
To compare 2 types of supervision in terms of:
The difference between the overall scores on the POMS-f before the start of treatment, at each treatment and after 3 courses of treatment
Measured: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks
toxicities
To compare 2 types of supervision in terms of proportion of patients with toxicity during treatment, and the maximum grade observed per patient
Measured: up to 15 weeks
quality of life
To compare 2 types of supervision in terms of:
The quality of life of the patient by the European Organization for Research and Treatment of Cancer Qulity of life questionnaire (EORTC QLQ-C30), before the start of treatment, during the 2nd cycle of chemotherapy and after three courses of treatment
Measured: Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks
anxiety
To compare 2 types of supervision in terms of:
The level of anxiety assessed by the number of visits to psychologists, psychiatrists, the sub-score "Anxiety" obtained in the Hospital Anxiety and Depression State (HADS) questionnaire, the anxiolytics and antidepressants intakes
Measured: up to 15 weeks
caregiver mood states
To compare 2 types of supervision in terms of:
- The overall scores obtained by the caregiver on the POMS-f before, during and after 3 courses of treatment
Measured: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks
patient satisfaction
To compare 2 types of supervision in terms of overall satisfaction scores obtained by the patient after 3 courses of treatment
Measured: up to 12 weeks
relationship between psychosocial criteria and anxiety
To compare 2 types of supervision in terms of:
- The relationship between the presence of psychosocial frailty criteria and the level of anxiety for patients in group B (number of visits to psychologists, psychiatrists; anxiolytics and antidepressants intake; HADS anxiety scores)
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-metastatic Patients With Breast CancerStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe FOLLANA, Dr., Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977053
- Sponsor's protocol ID
- 2012/04
- Other IDs
- 2013-A00506-39
- Acronym
- EMOTION
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2013
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ganz PA, Kwan L, Stanton AL, Krupnick JL, Rowland JH, Meyerowitz BE, Bower JE, Belin TR. Quality of life at the end of primary treatment of breast cancer: first results from the moving beyond cancer randomized trial. J Natl Cancer Inst. 2004 Mar 3;96(5):376-87. doi: 10.1093/jnci/djh060.
PubMed 14996859Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775.
PubMed 17093275Carlson LE, Bultz BD. Cancer distress screening. Needs, models, and methods. J Psychosom Res. 2003 Nov;55(5):403-9. doi: 10.1016/s0022-3999(03)00514-2.
PubMed 14581094Pitceathly C, Maguire P. The psychological impact of cancer on patients' partners and other key relatives: a review. Eur J Cancer. 2003 Jul;39(11):1517-24. doi: 10.1016/s0959-8049(03)00309-5.
PubMed 12855257Vitek L, Rosenzweig MQ, Stollings S. Distress in patients with cancer: definition, assessment, and suggested interventions. Clin J Oncol Nurs. 2007 Jun;11(3):413-8. doi: 10.1188/07.CJON.413-418.
PubMed 17623625Contu S, Hebert C, Ferrero JM, Creisson A, Mari V, Kaluzinski L, Hoch B, Largillier R, Borchiellini D, Viellard T, Chateau Y, Chamorey E, Follana P. EMOTION: Assessing the Impact of a Telephone Intervention for Patients With Breast Cancer, a Randomized Controlled Trial. JCO Oncol Pract. 2026 Mar;22(3):474-483. doi: 10.1200/OP-24-00857. Epub 2025 Jun 11.
PubMed 40499090
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01977053
- Acronym / sponsor ID
- EMOTION / 2012/04
- Conditions
- Non-metastatic Patients With Breast Cancer, Non-metastatic Patients With Colon Cancer, Non-metastatic Patients With Rectal Cancer, Patients Undergoing Adjuvant Chemotherapy
- Keywords
- breast cancer, colon cancer, rectal cancer, adjuvant chemotherapy, phone calls, emotional states, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Nov 2013 (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.
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.
The patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and / or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
Detailed description
Cancer is widely associated with the concept of psychological distress in a population of patients subject to numerous stressful events. Between 10 to 50% of patients with cancer and their families suffer from clinically significant psychological disorders.
The existence of a broad continuum of manifestations of distress makes it difficult for clinical evaluation. Underestimated and misjudged, it is not always taken into account appropriately. However, these problems have a direct impact not only on the quality of life of patients but also on their ability to share decisions , adhere to treatment, and therefore to get the best care available for the treatment of their cancer.
Interactions between the presence of psychopathological disorders, quality of life and treatment toxicities will be the focus of this study assessing the impact of telephonic monitoring (targeting clinical, psychological and social objectives) in patients with current chemotherapy.
There are communication difficulties on the distress between the patient and the doctor, in part due to the gap between the perceptions of the patient and the caregiver. Indeed, many studies have highlighted the important differences existing between subjective psychosocial needs of the patient and the physician's ability to detect them. In particular, the study of Fallowfield on nearly 2300 medical consultations shows that only 29% of patients whose threshold of distress is clinically significant are identified by their doctors. Similarly, the synthesis carried out in 2005 by Thorne et al. reported the impact of failures of communication between clinicians and patients on the psychosocial experience of illness and treatment, symptom management, decision making and quality of life.
Justification and research hypothesis
In health care, the phone has emerged as a clinical tool in its own right, especially for the development of psychological support to patients and that, in many pathologies. Its potential in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a telephone call to both the anxiety and the management of side effects of neoadjuvant or adjuvant chemotherapy.
The patient incomplete care by the hospital system and the general practitioner during chemotherapy, as well as the lack of information and poor preparation and / or management of side effects, are a source of distress and lead to a decrease quality of life for the patient and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during the first 3 inter-treatment intervals, the overall measure of mood states (anxiety, depression , confusion , anger , fatigue , vigor and interpersonal ) of the patient and his entourage . We also study the gain in quality of life, anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
We propose to determine on a population of 280 patients, the impact of two phone calls during the 3 first inter-treatment intervals on the overall measure of mood states of the patient and his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation). We will also study the gain in quality of life, on anxiety level, frequency and severity of toxicities, as well as emotional comfort of the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Standard medical care | No intervention | –Arm A: standard supervision and medical care during an adjuvant chemotherapy treatment in France |
| B: telephonic monitoring | Experimental | Other: Clinical and psychosocial phone callsArm B: telephonic monitoring during inter-treatment intervals + personalized medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient older than 18.
- Patient surgically-treated or no for non inflammatory breast cancer or for colon cancer or rectal cancer.
- Patient to be treated by neo-adjuvant or adjuvant chemotherapy by 5-fluorouracil, epirubicin and cyclophosphamide (FEC)-docetaxel, docetaxel-cyclophosphamide, 5-fluorouracil/leucovorin with oxaliplatin(FOLFOX) or XELOX. A treatment with trastuzumab is allowed in association.
- Patient never treated by chemotherapy.
- Patient with Performance Status under or equal to 2.
Key exclusion criteria (6 listed)
- Patient with psychological state, geographical remote or social problems that contraindicated the participation into the study according to the investigator.
- Patient that must be treated for a metastatic disease.
- Patient not able to attend all study visits.
- Patient not understanding French.
- Patient who don't have a phone.
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 |
|---|---|---|
| Clinical and psychosocial phone callsAlso: medical care including social and psychological domainsThe standard medical supervision is defined as follows: * Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy. * Nominative notebook containing details of chemotherapy administered and medical contacts. * Consultations with psycho-oncologist or psychiatrist (if necessary). The intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported. | Other | B: telephonic monitoring |
Primary outcome
emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation)
Time frame: Change from baseline in POMS-f score at 6 weeks
comparison of the 2 types of monitoring in terms of overall measure of emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) of patients, with Profile of Mood States (POMS-f) questionnaire.
7 secondary outcomes
Evolution of emotional states scores
Time frame: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks
toxicities
Time frame: up to 15 weeks
quality of life
Time frame: Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks
anxiety
Time frame: up to 15 weeks
caregiver mood states
Time frame: Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks
patient satisfaction
Time frame: up to 12 weeks
relationship between psychosocial criteria and anxiety
Time frame: up to 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 14996859Ganz PA, Kwan L, Stanton AL, Krupnick JL, Rowland JH, Meyerowitz BE, Bower JE, Belin TR. Quality of life at the end of primary treatment of breast cancer: first results from the moving beyond cancer randomized trial. J Natl Cancer Inst. 2004 Mar 3;96(5):376-87. doi: 10.1093/jnci/djh060.
- Background: PubMed 17093275Stanton AL. Psychosocial concerns and interventions for cancer survivors. J Clin Oncol. 2006 Nov 10;24(32):5132-7. doi: 10.1200/JCO.2006.06.8775.
- Background: PubMed 14581094Carlson LE, Bultz BD. Cancer distress screening. Needs, models, and methods. J Psychosom Res. 2003 Nov;55(5):403-9. doi: 10.1016/s0022-3999(03)00514-2.
- Background: PubMed 12855257Pitceathly C, Maguire P. The psychological impact of cancer on patients' partners and other key relatives: a review. Eur J Cancer. 2003 Jul;39(11):1517-24. doi: 10.1016/s0959-8049(03)00309-5.
- Background: PubMed 17623625Vitek L, Rosenzweig MQ, Stollings S. Distress in patients with cancer: definition, assessment, and suggested interventions. Clin J Oncol Nurs. 2007 Jun;11(3):413-8. doi: 10.1188/07.CJON.413-418.
- Results publication: PubMed 40499090Contu S, Hebert C, Ferrero JM, Creisson A, Mari V, Kaluzinski L, Hoch B, Largillier R, Borchiellini D, Viellard T, Chateau Y, Chamorey E, Follana P. EMOTION: Assessing the Impact of a Telephone Intervention for Patients With Breast Cancer, a Randomized Controlled Trial. JCO Oncol Pract. 2026 Mar;22(3):474-483. doi: 10.1200/OP-24-00857. Epub 2025 Jun 11.
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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.
Philippe FOLLANA, Dr. principal investigator
Centre Antoine Lacassagne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and psychosocial phone calls in people with Non-metastatic Patients With Breast Cancer and Non-metastatic Patients With Colon Cancer, run by Centre Antoine Lacassagne at 2 sites in France.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) (time frame: Change from baseline in POMS-f score at 6 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 NCT01977053, which also lists 6 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 23 Apr 2026.