Oral TherapiesNCT01597284
Oral Therapies in Oncology: Cognitive Function and Compliance
An observational study of Oral Therapies and Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Therapies, Cancer, Cognitive Function
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Mar 2016
- Phase
- Observational
- 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
Study population: Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)
Who may be able to join
- Age over 18 years,
- Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer,
- Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables,
- Patients with asymptomatic brain metastases are incluables,
- Lack of personality disorders and psychiatric illness scalable,
- Knowledge of spoken and written French,
- Having signed the informed consent of study participation.
Who cannot join
- Pathology psychiatric
- Refusal to participate,
- Patient unable to respond to cognitive tests, - Documented use of drugs,
- Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan
- Conditions
- Oral Therapies, Cancer, Cognitive Function, Compliance
- Keywords
- Oral therapies, Cancer, cognitive function, compliance
- Medical subject headings
- Neoplasms, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Loss of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral TherapiesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOLY Florence, PhD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597284
- Sponsor's protocol ID
- COG-OBS
- Status last verified
- Mar 2016
- First submitted
- 10 May 2012
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Therapies in Oncology: Cognitive Function and Compliance
- ClinicalTrials.gov ID
- NCT01597284
- Acronym / sponsor ID
- COG-OBS
- Conditions
- Oral Therapies, Cancer, Cognitive Function, Compliance
- Keywords
- Oral therapies, Cancer, cognitive function, compliance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of recruitment
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 May 2012 (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 investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)
Key inclusion criteria (7 listed)
- Age over 18 years,
- Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer,
- Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables,
- Patients with asymptomatic brain metastases are incluables,
- Lack of personality disorders and psychiatric illness scalable,
Key exclusion criteria (4 listed)
- Pathology psychiatric
- Refusal to participate,
- Patient unable to respond to cognitive tests, - Documented use of drugs,
- Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.
Time frame: 8 months
Results and safety
The study was stopped early (reason given: Loss of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Related trials for Oral Therapies
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
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.
JOLY Florence, PhD principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Therapies and Cancer, run by Centre Francois Baclesse at 1 site 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Feb 2017. 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 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 was stopped early (reason given: Loss of recruitment). 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?
Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment. (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.