Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range

October 30, 2015 updated by: Claire Kelly

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the second most common cancer worldwide, and the most frequent cancer among females with nearly 1.67 million new cases diagnosed in 2012 (WHO, 2012). Due to population increases, health service and cancer awareness, more women are diagnosed with breast cancer each year. Advances in diagnosis and in treatment have seen an increase in survival from breast cancer for Irish women in recent years (ABC, 2010). In Ireland, after non-melanoma skin cancer, breast cancer is the most common tumour diagnosed in women in 2008-2010. With an average annual amount of 2,767 women diagnosed with breast cancer in 2008-2010 (NCRI, 2013). As a result, more women are living with the permanent effects of breast cancer (Gho et al., 2010).

For patients' newly diagnosed with breast cancer, surgery is the first choice of treatment. 84% of females receive surgery as a form of treatment, be it as a single modality or in combination with radiotherapy, chemotherapy and/or hormone therapy (NCRI, 2012).

A randomized interventional comparative control study will be undertaken to compare the THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial mastectomies and total mastectomies 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.

Who can participate? Women over the age of 18 years with no upper age limit, with a newly diagnosed breast cancer that are planned to undergo breast surgery as treatment in a 3 month period from recruitment.

What does the study involve? Participants will be randomly assigned, by use of a sealed envelope into two groups: an intervention and a control group.

Women in the intervention group will be fitted by the investigator with a THEYA Recovery bra.

Women in the control group will have standard post-operative care, with recommended bra or fitted by the Breast Care Nurse Specialist.

All participants will complete three questionnaires before fitting : The Breast Q, The Body Image Scale and the EQ 5D 3L.

All participants will be asked to continue wearing bra for a period of three to four weeks, then re-assessed on return visit, with re-assessment of the three questionnaires. 30 partcipants will be randomly selected from the sealed envelope to undergo a semi-structured interview, in order to gain a better understanding of their experience.

What are the possible benefits and risks of participating? The benefits for participating include receiving the same level of care, and for those undergoing lumpectomy a free bra. The study aims to evaluate the patients requirements in post-operative lingerie in order to help and further assiss these women. As this is an area of minimal research. There are no risks envisaged from participating in this study.

Where is the study run from? The study is ran from The Beacon Hospital, Mater Misericordiae University Hospital, Mater Private Hospital and St.James's Hospital.

When is the study starting and how long is it expected to run for? The study is planned to start in November 2015 and is expected to run until December 2016.

Who is funding the study? The study is being funded from the Irish Research Council and THEYA as part of an Employment Based PostGraduate Award.

Who is the main contact? Claire Kelly, Researcher.

claire@theya.healthcare

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female over the age of 18 years, with no maximum age limit once all other criteria are met.
  2. Have a comprehensive understanding and fluency of the English language with the ability to provide informed consent.
  3. 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.
  4. 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.
  5. Be available for the full duration of the study which will be 3 months from recruitment to post-assessment.

Exclusion Criteria:

  1. Are under the age of 18 years.
  2. Do not have intellectual capacity to provide informed consent.
  3. Are not scheduled to undergo a mastectomy or lumpectomy within a 3 month period of recruitment.
  4. 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.
  5. Those that are not fluent English speakers, grossly hearing or speech impaired.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Arm A: Participants will be fitted with the THEYA Recovery bra
Device: THEYA Recovery Range
Post-operative Lingerie made from viscose derived bamboo
No Intervention: Control
Arm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THEYA Recovery post-surgery bra impacted on the participant's quality of life using the 2009 EuroQol Group questionnaire EQ-5D-5L.
Time Frame: Four weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
THEYA Recovery post-surgery bra impact on Body Image using The Body Image Scale (Hopwood et al, 2001)
Time Frame: Four weeks

The scale consists of ten questions for assessment. Response options range from ''not at all'' (score 0), ''a little'' (score 1), ''quite a bit'' (score 2) to ''very much'' (score 3).

A total score ranging from 0 to 30 per patient with 0 representing no distress or symptoms, whereas increasing scores represent increasing distress and symptoms.
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.
Time Frame: Four weeks
Breast-Q Questionnaire (measure through questionnaires the quality of life and psychosocial indicators specific to breast cancer survivors)
Four weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Four weeks
A qualitative semi-structured interview designed by the researcher to evaluate the lived experience of the participants.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claire Kelly

Collaborators

University College Dublin
Irish Research Council

Investigators

  • Study Director: Amanda McCann, PhD, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THEYARCT2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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