Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
A randomised interventional comparative control study will be undertaken to compare the THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial mastectomies and total mastectomies to current practice using a mixed method combining quantitative and qualitative instruments. 100 female participants are hoped to be recruited following breast surgery after a newly diagnosed breast cancer. This study will answer the research question:- "What is the clinical and psychosocial impact of the THEYA Recovery Range in comparison to recommended practice during and after breast cancer treatment?" This study will leverage the findings of a pilot study conducted by Applied Research Connected Healthcare (ARCH) measuring the usability of the THEYA Recovery Range. This study aims to assess the participants' experience of recovery in the immediate post-operative period and the psychosocial effect of THEYA Recovery Range in comparison to current recommended practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Nov 2015
Shorter than P25 for not_applicable breast-cancer
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
October 14, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 2, 2015
October 1, 2015
1.1 years
October 14, 2015
October 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
THEYA Recovery post-surgery bra impacted on the participant's quality of life using the 2009 EuroQol Group questionnaire EQ-5D-5L.
The EQ-5D-3L measures the respondent's health related Quality of Life 100 represents the "Best imaginable health status' and 0 represents the 'Worst imaginable health status'
Four weeks
Secondary Outcomes (2)
THEYA Recovery post-surgery bra impact on Body Image using The Body Image Scale (Hopwood et al, 2001)
Four weeks
THEYA Recovery post-surgery bra impact on feminity, sexuality, pain, sleep distrubance, body image assessed by The Breast Q Mastectomy or The Breast Q Breast Conserving Treatment, derived by Memorial Sloan Kettering.
Four weeks
Other Outcomes (1)
The participants' explained perceptions of the comfort, functionality and reported levels of health and wellbeing compared to the control, following a semi-structured interview. Measured through qualitative analysis using NVivo package.
Four weeks
Study Arms (2)
Intervention
ACTIVE COMPARATORArm A: Participants will be fitted with the THEYA Recovery bra
Control
NO INTERVENTIONArm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist
Interventions
Eligibility Criteria
You may qualify if:
- Female over the age of 18 years, with no maximum age limit once all other criteria are met.
- Have a comprehensive understanding and fluency of the English language with the ability to provide informed consent.
- Be scheduled to undergo a mastectomy or lumpectomy for a new first time diagnosis of breast cancer within a 3 month period of recruitment - as this cohort are the principal users of post-surgery bras.
- No pre-existing severe co-morbidities and / or documented psychological diagnosis i.e. depression, severe chronic disease - as we do not want to over-burden a person who has any ailments other than their surgery discomfort. As well as that, the bra is designed to help recovery from breast surgery, and having further ailments may alter data we receive.
- Be available for the full duration of the study which will be 3 months from recruitment to post-assessment.
You may not qualify if:
- Are under the age of 18 years.
- Do not have intellectual capacity to provide informed consent.
- Are not scheduled to undergo a mastectomy or lumpectomy within a 3 month period of recruitment.
- Have pre-existing severe co-morbiditie(s) and / or documented psychological diagnosis, as the diagnosis of breast cancer is challenging enough and it may exacerbate any psychological condition, and the researcher would like to avoid any perceived additional stress for them.
- Those that are not fluent English speakers, grossly hearing or speech impaired.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Claire Kellylead
- University College Dublincollaborator
- Irish Research Councilcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amanda McCann, PhD
University College Dublin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Claire Kelly
Study Record Dates
First Submitted
October 14, 2015
First Posted
November 2, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
November 2, 2015
Record last verified: 2015-10