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"Impact of Chemotherapy-induced Alopecia on the Quality of Life of Women With Breast Cancer"

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ClinicalTrials.gov Identifier: NCT02797223
Recruitment Status : Unknown
Verified June 2016 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:

The main objective of this qualitative phenomenological study is to understand the impact of chemotherapy-induced alopecia, the quality of life of women with breast cancer from this experience.

The study will be conducted in the day hospital oncology-hematology of the Hospital de la Santa Creu i Sant Pau. Data collection will be done through semi-structured interviews. About 12 to 14 interviews throughout the study was conducted. So in the study involved a total of between 12 and 14 women.

These will be recorded in voice and then transcribe and code. From reading and re-reading the patterns or data that relate to each other, thus establishing the categories (thematic analysis) were identified. These categories describe the experiences of the participants alopecia.


Condition or disease Intervention/treatment
Chemotherapy-induced Alopecia Behavioral: Semi-structured interviews

Detailed Description:

The main objective of this study is to understand the impact of chemotherapy-induced alopecia, the quality of life of women with breast cancer from this experience.

Therefore, it is a qualitative phenomenological study. The problem of the study is the impact of alopecia as a side effect of chemotherapy in women with breast cancer in the areas of privacy, welfare, sexuality and femininity, self-esteem, social relations and the world of work.

The study will be conducted in the day hospital oncology-hematology of the Hospital de la Santa Creu i Sant Pau. Data collection will be done through semi-structured interviews. Each interview will last between 60 and 90 minutes will be the participant who decides the date and time. The site will be a day hospital office.

It will be the same researcher who interviewed and analyze them. To make the selection of participants with an opinion sampling is performed. Attracting participants who are patients in the study investigator.

Inclusion criteria are: being female, of age, suffer from breast cancer, receive or have received chemotherapy have the side effect of alopecia and alopecia file or have filed at the time of the interview. Excluded from the study participants to present cognitive impairment, intellectual disability, presence of disease that prevents the story of their experience and / or not be able to sign the study informed orally and written consent.

About 12 to 14 interviews throughout the study was conducted. So in the study involved a total of between 12 and 14 women.

These will be recorded in voice and then transcribe and code. From reading and re-reading the patterns or data that relate to each other, thus establishing the categories (thematic analysis) were identified. These categories describe the experiences of the participants alopecia.

In a first phase of the project only 6 interviews will be conducted, as it requires the presentation of preliminary results as part of a master work carried out by the principal investigator. Subsequently, the remaining interviews will be conducted and the results will be analyzed in its entirety.

These six interviews are conducted between June and July 2016 total planned month duration of the study: 8 months.

Ethical considerations of this study are that to participate in the study informed consent is required describing procedures and the role of the participants, stressing the voluntary and total freedom to leave when they want. where the information sheet explaining why the study, its purpose and the importance of their participation among others shall also be included.

In addition, interviews will be recorded only voice and difficult to identify the participants. Finally, compliance with current regulations concerning the confidentiality and anonymity of the data is guaranteed.

This study does not have sources of funding.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: "Impacto de la Alopecia Inducida Por Quimioterapia en la Calidad de Vida de Mujeres Con cáncer de Mama"
Study Start Date : June 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Semi-structured interviews
    Qualitative phenomenological study. Data collection will be done through semi-structured interviews. Each interview will last between 60 and 90 minutes. It will be the same researcher who interviewed and analyze them.


Primary Outcome Measures :
  1. Quality of life [ Time Frame: 8 months ]
    Impact of chemotherapy-induced alopecia on the quality of life of women with breast cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women suffered breast cancer and alopecia post treatment
Criteria

Inclusion Criteria:

  • Being female, > 18 years old, suffer from breast cancer, receive or have received chemotherapy have the side effect of alopecia and alopecia file or have filed at the time of the interview.

Exclusion Criteria:

  • Participants to present cognitive impairment, intellectual disability, presence of disease that prevents the story of their experience and / or not be able to sign the study informed orally and written consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797223


Contacts
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Contact: Jorgina Serra, Nurse 0034-678891527 jserral@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Jorgina Serra, Nurse    +34678891527    jserral@santpau.cat   
Principal Investigator: Jorgina Serra         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Jorgina Serra, Nurse Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02797223     History of Changes
Other Study ID Numbers: IIBSP-CAL-2016-20
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
alopecia
chemotherapy
breast cancer

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical