Follicular Thyroid CancerNCT03639662
Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer
A study testing sophrology sessions in people with Follicular Thyroid Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Follicular thyroid cancers are excellent prognoses. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Thyroid Cancer
- What is being tested?
- sophrology sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Nov 2022
- 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
- Major subject, affiliated to a social security scheme;
- Subject accepting to participate in the study and having signed informed consent; Subject with histologically confirmed follicular thyroid cancer (initial diagnosis);
- Subject having a minimum period of 4 weeks between surgery and the administration of iodine 131.
Who cannot join
- Subjects with any of the following criteria will not be included:
- Subject with thyroid cancer known as distant metastatic
- Subject presenting another evolutionary cancer
- Subject not mastering the French language
- Subject presenting severe affective, behavioral or psychiatric disorders which, according to the investigator, compromise the ability to meet the requirements of the study.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
PATRICIA OLIVE, MD, +33 491385867, Patricia.OLIVE@ap-hm.fr
About this study
Official title: Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer Compared With Usual Initial Management: Multicenter Randomized Prospective Study
Follicular thyroid cancers are excellent prognoses. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells remaining and thus minimize the risk of recurrence and facilitate future controls.
Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH.
Read more
Then, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases.
It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety?
Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality.
No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life.
The aim is to offer patients a sophrological support provided by each of the 3 participating centers. These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.
Read the detailed description
Follicular thyroid cancers are excellent prognoses (> 90% survival at all stages at 10 years). They occur preferentially in women where they represent the 5th cause of cancer and less than 0.5% of the causes of cancer mortality. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells (normal or cancerous) remaining and thus minimize the risk of recurrence and facilitate future controls (the blood test of thyroglobulin produced only by the thyroid cells can be used as a marker of persistence / recurrence of the disease).
Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH.
Approximately one week after iodine-131, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases.
It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety?
Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality.
Previous work has already demonstrated the interest of sophrology in different situations such as the management of cancer patients, before performing a bronchial fibroscopy, a ventilation session as part of the management of cancer. neuropathic pain, but also in the elderly and finally in people cared for infertility.
No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life.
The aim is to offer patients a sophrological support provided by each of the 3 participating centers (CHU Marseille, Institut Claudius Regaud Toulouse, Center Jean Perrin Clermont-Ferrand). These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.
- Conditions
- Follicular Thyroid Cancer
- Being tested
- sophrology sessions
- Medical subject headings
- Adenocarcinoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sophrology sessionsOther
Patients benefit from additional support consisting of at least 3 sessions of sophrology, one per week, from the week following the announcement of the diagnosis and until the week preceding the hospitalization for irathérapie. It will be group sessions, 1h carried out in the participating center by a nurse sophrologist who will use the techniques of sophrology such as relaxation, breath control, mastery of thoughts and visualization. Each session will be recorded in digital format and the recording will be given to the patient at the end of the session so that he can, if he wishes, reproduce it at home.
Patients will also be able to share their feelings and ask questions
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Patients benefit from additional support consisting of at least 3 sessions of sophrology (sophrology sessions), one per week, from the week following the announcement of the diagnosis and until the week preceding the hospitalization for "iratherapie". It will be group sessions, 1h carried out in the participating center by a nurse sophrologist who will use the techniques of sophrology such as relaxation, breath control, mastery of thoughts and visualization. Each session will be recorded in digital format and the recording will be given to the patient at the end of the session so that he can, if he wishes, reproduce it at home.
Patients will also be able to share their feelings and ask questions Receives: Other: sophrology sessions |
| control group | No intervention | Between the announcement of their thyroid cancer and the post-therapeutic scintigraphy, the patients will follow the usual route: information on the management, receipt of an information booklet (containing the telephone contacts of the hospital units), and they wish it, meet with the staff and visit a room of hospitalization. The nurses of the hospitalization service are available to answer any questions they may have, either during this visit or during a telephone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score to STAI questionnaire
The State-Trait Anxiety Inventory (STAI) is a self-questionnaire, developed by Spielberger (7) and validated in French. It has 20 questions, assessing the subject's usual emotional state. A score is calculated, ranging from 20 to 80, a high score indicating the presence of anxiety.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639662
- Sponsor's protocol ID
- RCAPHM18_0016
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer Compared With Usual Initial Management: Multicenter Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03639662
- Acronym / sponsor ID
- RCAPHM18_0016
- Conditions
- Follicular Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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.
Follicular thyroid cancers are excellent prognoses. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells remaining and thus minimize the risk of recurrence and facilitate future controls.
Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH.
Then, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases.
It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety?
Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality.
No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life.
The aim is to offer patients a sophrological support provided by each of the 3 participating centers. These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.
Detailed description
Follicular thyroid cancers are excellent prognoses (> 90% survival at all stages at 10 years). They occur preferentially in women where they represent the 5th cause of cancer and less than 0.5% of the causes of cancer mortality. However, there is a very clear negative impact of the diagnosis on patients' quality of life, partly because of initial care. The therapeutic sequence is often the following: surgery and complementary administration of radioactive iodine 131. This treatment will destroy all thyroid cells (normal or cancerous) remaining and thus minimize the risk of recurrence and facilitate future controls (the blood test of thyroglobulin produced only by the thyroid cells can be used as a marker of persistence / recurrence of the disease).
Radioactive iodine uptake is optimized by stimulating thyroid cells that fix iodine better when the level of TSH is high. For this purpose, hypothyroidism is induced by weaning in hormone replacement therapy or injected with recombinant TSH.
Approximately one week after iodine-131, a full-body scintigraphy extension is performed followed by a medical consultation. This scintigraphy shows the tissues that fixed the iodine 131, the residual tissues after surgery and / or possible distant metastases.
It is recognized that when a patient learns that he has thyroid cancer, he is subject to increasing anxiety between the time of diagnosis and post-treatment scintigraphy. These patients and their loved ones are often distraught and anticipate their future in a negative way, while long-term survival is excellent. How to get these patients to consider their pathology more objectively and thus reduce their anxiety?
Sophrology is a psychocorporal method aimed at balancing our emotions, thoughts and behaviors. We suppose that if these patients could benefit from a sophrological accompaniment between the announcement of the diagnosis and the scintigraphy, they could apprehend their pathology with more serenity and reality.
Previous work has already demonstrated the interest of sophrology in different situations such as the management of cancer patients, before performing a bronchial fibroscopy, a ventilation session as part of the management of cancer. neuropathic pain, but also in the elderly and finally in people cared for infertility.
No studies providing sophrological support to patients with thyroid cancer have been performed. The anxiety of these patients being largely linked to a feeling of isolation and excessive danger, we think that this care will have an immediate favorable effect on their anxiety, or even in the longer term on their quality of life.
The aim is to offer patients a sophrological support provided by each of the 3 participating centers (CHU Marseille, Institut Claudius Regaud Toulouse, Center Jean Perrin Clermont-Ferrand). These group sessions will allow them to understand the place of their future hospitalization, to share with other patients, to obtain answers to their questions, to be listened to with neutrality and empathy, and to learn management techniques. their anxiety in order to reproduce them at home. They will be followed and will not feel abandoned in the face of their distress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: sophrology sessionsPatients benefit from additional support consisting of at least 3 sessions of sophrology (sophrology sessions), one per week, from the week following the announcement of the diagnosis and until the week preceding the hospitalization for "iratherapie". It will be group sessions, 1h carried out in the participating center by a nurse sophrologist who will use the techniques of sophrology such as relaxation, breath control, mastery of thoughts and visualization. Each session will be recorded in digital format and the recording will be given to the patient at the end of the session so that he can, if he wishes, reproduce it at home. Patients will also be able to share their feelings and ask questions |
| control group | No intervention | –Between the announcement of their thyroid cancer and the post-therapeutic scintigraphy, the patients will follow the usual route: information on the management, receipt of an information booklet (containing the telephone contacts of the hospital units), and they wish it, meet with the staff and visit a room of hospitalization. The nurses of the hospitalization service are available to answer any questions they may have, either during this visit or during a telephone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major subject, affiliated to a social security scheme;
- Subject accepting to participate in the study and having signed informed consent; Subject with histologically confirmed follicular thyroid cancer (initial diagnosis);
- Subject having a minimum period of 4 weeks between surgery and the administration of iodine 131.
Key exclusion criteria (5 listed)
- Subject with thyroid cancer known as distant metastatic
- Subject presenting another evolutionary cancer
- Subject not mastering the French language
- Subject presenting severe affective, behavioral or psychiatric disorders which, according to the investigator, compromise the ability to meet the requirements of the study.
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 |
|---|---|---|
| sophrology sessionsPatients benefit from additional support consisting of at least 3 sessions of sophrology, one per week, from the week following the announcement of the diagnosis and until the week preceding the hospitalization for irathérapie. It will be group sessions, 1h carried out in the participating center by a nurse sophrologist who will use the techniques of sophrology such as relaxation, breath control, mastery of thoughts and visualization. Each session will be recorded in digital format and the recording will be given to the patient at the end of the session so that he can, if he wishes, reproduce it at home. Patients will also be able to share their feelings and ask questions | Other | experimental group |
Primary outcome
Score to STAI questionnaire
Time frame: 1 hour
The State-Trait Anxiety Inventory (STAI) is a self-questionnaire, developed by Spielberger (7) and validated in French. It has 20 questions, assessing the subject's usual emotional state. A score is calculated, ranging from 20 to 80, a high score indicating the presence of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sophrology sessions in people with Follicular Thyroid Cancer, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 5 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 21 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact patricia OLIVE, MD (+33 491385867, Patricia.OLIVE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score to STAI questionnaire (time frame: 1 hour). 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 21 Aug 2018.