NCT02797223

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

Same day

First QC Date

May 27, 2016

Last Update Submit

June 10, 2016

Conditions

Keywords

alopeciachemotherapybreast cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Impact of chemotherapy-induced alopecia on the quality of life of women with breast cancer

    8 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women suffered breast cancer and alopecia post treatment

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

AlopeciaBreast Neoplasms

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast Diseases

Study Officials

  • Jorgina Serra, Nurse

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorgina Serra, Nurse

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 13, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations