Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer

Follicular Thyroid Cancer Clinical Trial

Official title:

Psychological Impact of a Sophrological Accompaniment During the Announcement of Thyroid Cancer Compared With Usual Initial Management: Multicenter Randomized Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03639662
• Other study ID #: RCAPHM18_0016
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: November 2022

Study information

• Verified date: August 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: patricia OLIVE, MD
• Phone: +33 491385867
• Email: Patricia.OLIVE[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: November 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Follicular Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• sophrology sessions
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

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour