deltatrials
Unknown OBSERVATIONAL NCT02797223

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

Impacto de la Alopecia Inducida Por Quimioterapia en la Calidad de Vida de Mujeres Con cáncer de Mama

Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Updated 8 times since 2017 Last updated: Jun 10, 2016 Started: Jun 30, 2016 Primary completion: Jun 30, 2016 Completion: Dec 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02797223, this observational or N/A phase trial focuses on Chemotherapy-induced Alopecia and remains ongoing. Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, it has been updated 8 times since 2016, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotRecruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotRecruiting~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Jul 2018 — Jan 2021 [monthly]

    Unknown Status

    Status: RecruitingUnknown Status

Show 3 earlier versions
  1. Jun 2018 — Jul 2018 [monthly]

    Recruiting

  2. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  3. Jan 2017 — Apr 2018 [monthly]

    Recruiting NA

    First recorded

Jun 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Data source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations