Chemotherapy-induced AlopeciaNCT02797223
"Impact of Chemotherapy-induced Alopecia on the Quality of Life of Women With Breast Cancer"
An observational study of Chemotherapy-induced Alopecia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Alopecia
- What is being tested?
- Semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Dec 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women suffered breast cancer and alopecia post treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Jorgina Serra, Nurse, +34678891527, jserral@santpau.cat
Jorgina Serra
About this study
Official title: "Impacto de la Alopecia Inducida Por Quimioterapia en la Calidad de Vida de Mujeres Con cáncer de Mama"
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.
Read the 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.
- Conditions
- Chemotherapy-induced Alopecia
- Being tested
- Semi-structured interviews
- Keywords
- alopecia, chemotherapy, breast cancer
- Medical subject headings
- Alopecia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Impact of chemotherapy-induced alopecia on the quality of life of women with breast cancer
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced AlopeciaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorgina Serra, Nurse, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797223
- Sponsor's protocol ID
- IIBSP-CAL-2016-20
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impacto de la Alopecia Inducida Por Quimioterapia en la Calidad de Vida de Mujeres Con cáncer de Mama"
- ClinicalTrials.gov ID
- NCT02797223
- Acronym / sponsor ID
- IIBSP-CAL-2016-20
- Conditions
- Chemotherapy-induced Alopecia
- Keywords
- alopecia, chemotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women suffered breast cancer and alopecia post treatment
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Semi-structured interviewsQualitative 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. | Behavioural | – |
Primary outcome
Quality of life
Time frame: 8 months
Impact of chemotherapy-induced alopecia on the quality of life of women with breast cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Chemotherapy-induced Alopecia
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Not yet recruitingPhase 2
Minoxidil With or Without Low-Level Red-Light Therapy for Improving Chemotherapy-Induced Alopecia in Breast Cancer Patients
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Clinical Study of DA-020 for the Treatment of Chemotherapy Induced Alopecia
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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.
Jorgina Serra, Nurse principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Alopecia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 1 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 13 Jun 2016. 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 Spain. 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 Jorgina Serra, Nurse (0034-678891527, jserral@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 8 months). 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 13 Jun 2016.