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出境医 / 临床实验 / Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer (QUALITY-AGE)
Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer (QUALITY-AGE)
Study Description
Brief Summary:
The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Other: self questionnaires | Not Applicable |
Detailed Description:
Evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer |
| Actual Study Start Date : | October 16, 2018 |
| Estimated Primary Completion Date : | October 2020 |
| Estimated Study Completion Date : | December 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Patient treated by adjuvant therapy
Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)
|
Other: self questionnaires
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS
|
Outcome Measures
Primary Outcome Measures :
- Assessment of Sexual Health [ Time Frame: one year ]assessment with Female sexual functionnal index (FSFI) self questionnaire
Secondary Outcome Measures :
- Assessment of Quality of life [ Time Frame: one year ]assessment with the Quality of life questionnaire (QLQ-C30) that contains 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions.
- Assessment of Body Image [ Time Frame: one year ]assessment with body image scale that contains 10 items dealing with body image
- Assessment ofTiredness [ Time Frame: one year ]assessment with Functionnal assessment of chronic illness therapy-Fatigue (FACIT-F) self questionnaire that contains 13 items dealing with fatigue
- Assessment of Anxiety [ Time Frame: one year ]assessment with Hospital anxiety and depression scale (HADS) that contains 15 items dealing with anxiety
- Assessment of Depression [ Time Frame: one year ]assessment geriatric depression scale (GDS 15 self questionnaire) that contains 15 item dealing with depression
Eligibility Criteria
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women over 65 years of age
- treatment by adjuvant therapy for breast cancer
- pTxNxM0
- sexually active at least three months before inclusion
- in couple or not
Exclusion Criteria:
- Inflammatory breast cancer
- Not sexually active before breast cancer diagnosis
- Opposition to fill sel questionnaire and collection of the data
Contacts and Locations
Contacts
| Contact: Olivier Rigal, MD | +33232082241 | olivier.rigal@chb.unicancer.fr | |
| Contact: Doriane Richard, PhD | +33232082985 | doriane.richard@chb.unicancer.fr |
Locations
| France | |
| CHU Amiens | Recruiting |
| Amiens, France | |
| Contact: Céline Bihan, MD | |
| Centre François Baclesse | Recruiting |
| Caen, France | |
| Contact: Carine Segura, MD | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76000 | |
| Contact: Olvier Rigal, MD | |
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
| Principal Investigator: | Olivier Rigal, MD | Centre Henri Becquerel |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||||||
| First Posted Date ICMJE | May 10, 2019 | ||||||||
| Last Update Posted Date | July 30, 2020 | ||||||||
| Actual Study Start Date ICMJE | October 16, 2018 | ||||||||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Assessment of Sexual Health [ Time Frame: one year ] assessment with Female sexual functionnal index (FSFI) self questionnaire
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer | ||||||||
| Official Title ICMJE | Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer | ||||||||
| Brief Summary | The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer | ||||||||
| Detailed Description | Evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other |
||||||||
| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE | Other: self questionnaires
FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS
|
||||||||
| Study Arms ICMJE | Patient treated by adjuvant therapy
Self questionnaires of sexual health and quality of life (FSFI, QLQ-C30, BR23, ELD 15, HADS, GDS 15, BIS, FACIT)
Intervention: Other: self questionnaires
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2021 | ||||||||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 65 Years and older (Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03946579 | ||||||||
| Other Study ID Numbers ICMJE | CHB18.04 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Henri Becquerel | ||||||||
| Study Sponsor ICMJE | Centre Henri Becquerel | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Centre Henri Becquerel | ||||||||
| Verification Date | July 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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