Anal CancerNCT00896467
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
An observational study of Anal Cancer and Anxiety Disorder, run by Centre Oscar Lambret at 2 sites in France.
Trial summary
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Anxiety Disorder, Breast Cancer
- What is being tested?
- questionnaire administration, psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2007to Nov 2010
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer
- Metastatic disease for which the median progression-free survival is ≥ 4 months
- Breast, digestive, kidney, lung
- Receiving first-line antitumor therapy (i.e., chemotherapy or targeted therapy) as part of either:
- Phase II or III randomized clinical trial
- Standard treatment off-trial
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-3 or Karnofsky PS 50-100%
- No psychological or physical inability to respond to a questionnaire
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No psychotropic treatment, except for antidepressants, anxiolytics, or sleeping pills taken for more than 30 days
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Oscar Lambret
Lille, 59020
Laboratoire URECA
Villeneuve-d'Ascq, 59653
About this study
Official title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.
PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.
Secondary
- To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
- To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
- To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.
OUTLINE: This is a multicenter study.
Patients complete four questionnaires, including assessment of symptoms of anxiety and depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of emotional behavior (ERQ), during their first course of treatment, after the first evaluation of treatment effectiveness, and one week after completion of treatment. During their first evaluation, patients also complete a questionnaire on the modalities of randomized clinical trials and their impact on care (ICEC-R).
- Conditions
- Anal Cancer, Anxiety Disorder, Breast Cancer, Depression, Esophageal Cancer, Gallbladder Cancer
- Being tested
- questionnaire administration, psychosocial assessment and care, quality-of-life assessment
- Keywords
- anxiety disorder, depression, stage IV breast cancer, stage IV renal cell cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, stage IV gastric cancer, stage IV anal cancer, stage IV pancreatic cancer, stage IV esophageal cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, small intestine cancer
- Medical subject headings
- Anus Neoplasms, Anxiety Disorders, Breast Neoplasms, Depression, Esophageal Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life as assessed by the QLQ-30 questionnaire
Symptoms of anxiety and depression as assessed by the HADS questionnaire
Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- Observational
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Investigators
- Stephanie Clisant, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896467
- Sponsor's protocol ID
- COL-0701
- Other IDs
- CDR0000626737, COL-IPSY, COL-RCB 2007-A00223-50, INCA-RECF0480
- Status last verified
- Jul 2009
- First submitted
- 8 May 2009
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology
- ClinicalTrials.gov ID
- NCT00896467
- Acronym / sponsor ID
- COL-0701
- Conditions
- Anal Cancer, Anxiety Disorder, Breast Cancer, Depression, Esophageal Cancer, Gallbladder Cancer
- Keywords
- anxiety disorder, depression, stage IV breast cancer, stage IV renal cell cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, stage IV gastric cancer, stage IV anal cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 May 2009 (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.
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.
PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.
Secondary
- To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
- To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
- To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.
OUTLINE: This is a multicenter study.
Patients complete four questionnaires, including assessment of symptoms of anxiety and depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of emotional behavior (ERQ), during their first course of treatment, after the first evaluation of treatment effectiveness, and one week after completion of treatment. During their first evaluation, patients also complete a questionnaire on the modalities of randomized clinical trials and their impact on care (ICEC-R).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| questionnaire administration | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Quality of life as assessed by the QLQ-30 questionnaire
Symptoms of anxiety and depression as assessed by the HADS questionnaire
Adjustment strategies and emotional regulation as assessed by the WCC and ERQ questionnaires
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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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.
Stephanie Clisant
Centre Oscar Lambret
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Anxiety Disorder, run by Centre Oscar Lambret 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?
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 Jul 2013. 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 was stopped early. 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?
Quality of life as assessed by the QLQ-30 questionnaire. The study lists 3 primary outcomes in all. 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 Jul 2013.