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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02474-41 | Other Identifier | IDRCB |
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The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.
Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life.
The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request.
For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving oncoSexology supportive care on proactive | Experimental | Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified. |
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| Patients receiving oncoSexology supportive care on request | Other | One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life questionnaire (QLQ) | Other | Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm | EORTC Sexual Health Questionnaire (SHQ)-C22 specific questionnaire sexual satisfaction scale score. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. | at 12 months after the inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Description of evolution in sexual quality of life | Scores obtained on the EORTC SHQ-C22 questionnaire scales. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore MOUSSION | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Emmanuelle TEXIER | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Véronique D'HONDT, Dr | Institut du Cancer de Montpellier (ICM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | Saint Herblain | 44805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29227723 | Background | Carter J, Lacchetti C, Andersen BL, Barton DL, Bolte S, Damast S, Diefenbach MA, DuHamel K, Florendo J, Ganz PA, Goldfarb S, Hallmeyer S, Kushner DM, Rowland JH. Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol. 2018 Feb 10;36(5):492-511. doi: 10.1200/JCO.2017.75.8995. Epub 2017 Dec 11. | |
| 35028721 |
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Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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| Satisfaction survey | Other | The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion). |
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| Assessment of patient needs in the field of oncosexology | Other | Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed. |
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| at inclusion, 6,12,18, and 24 months before inclusion |
| Description of evolution in quality of life - QLQ-C30 | Scores obtained on the scales of the EORTC QLQ-C30. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | at inclusion, 6,12,18, and 24 months before inclusion |
| Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires. | Scores obtained on the scales of the QLQ-BR23 This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms. | at inclusion, 6,12,18, and 24 months before inclusion |
| Search for associations between comorbidities and risk factors | Coefficients obtained with a model adapted for longitudinal quality of life data scores as a function of covariates potentially associated with sexual and global quality of life. | at inclusion, 6,12,18, and 24 months before inclusion |
| Search for associations between comorbidities and risk factors -questionnaire | Anxiety and depression (psychological distress variables) will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. | at inclusion, 6,12,18, and 24 months before inclusion |
| Assessment of adherence to the programme in the interventional arm | Percentage of adherence in the interventional arm | at inclusion |
| Oncosexology programme satisfaction | Satisfaction score measured on a visual analogue scale ranging from 1 to 10 (10 indicating high satisfaction) | at 24 months before inclusion |
| Oncosexology programme satisfaction | Scores obtained of the Satisfaction questionnaire by arm. All the scale ranging from 1 to 5 (5 indicating high satisfaction). | at 24 months before inclusion |
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | Vandoeuvre LES Nancy | 54519 | France |
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| Centre Léon Bérard | Not yet recruiting | Lyon | 69008 | France |
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| ICM Val d'Aurelle | Recruiting | Montpellier | 34298 | France |
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| Centre Antoine Lacassagne | Not yet recruiting | Nice | 06189 | France |
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| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
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| Institut Curie | Recruiting | Paris | 75005 | France |
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| IUCT - Oncopole | Recruiting | Toulouse | 31100 | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
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| Background |
| Bobrie A, Jarlier M, Moussion A, Jacot W, D'Hondt V. Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures. Support Care Cancer. 2022 Apr;30(4):3633-3641. doi: 10.1007/s00520-022-06810-3. Epub 2022 Jan 14. |
| 30765487 | Background | Del Pup L, Villa P, Amar ID, Bottoni C, Scambia G. Approach to sexual dysfunction in women with cancer. Int J Gynecol Cancer. 2019 Mar;29(3):630-634. doi: 10.1136/ijgc-2018-000096. Epub 2019 Feb 13. |
| 19614908 | Background | Dizon DS. Quality of life after breast cancer: survivorship and sexuality. Breast J. 2009 Sep-Oct;15(5):500-4. doi: 10.1111/j.1524-4741.2009.00766.x. Epub 2009 Jul 14. |
| 33233583 | Background | Seguin L, Touzani R, Bouhnik AD, Charif AB, Marino P, Bendiane MK, Goncalves A, Gravis G, Mancini J. Deterioration of Sexual Health in Cancer Survivors Five Years after Diagnosis: Data from the French National Prospective VICAN Survey. Cancers (Basel). 2020 Nov 20;12(11):3453. doi: 10.3390/cancers12113453. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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