Breast CancerNCT02593890
Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range
A study testing THEYA Recovery Range in people with Breast Cancer, run by Claire Kelly.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- THEYA Recovery Range
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Amanda McCann, PhD contact
About this study
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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- THEYA Recovery Range
- Keywords
- Breast Cancer, Breast Surgery, Mastectomy, Lumpectomy, Post-operative, Bra, Lingerie, Body Image, Psycho-social, Impact
- Medical subject headings
- Breast Neoplasms, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THEYA Recovery RangeDevice
Post-operative Lingerie made from viscose derived bamboo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Arm A: Participants will be fitted with the THEYA Recovery bra Receives: Device: THEYA Recovery Range |
| Control | No intervention | Arm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: Four weeks
Secondary outcomes (2)
THEYA Recovery post-surgery bra impact on Body Image using The Body Image Scale (Hopwood et al, 2001)
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.
Measured: 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.
Breast-Q Questionnaire (measure through questionnaires the quality of life and psychosocial indicators specific to breast cancer survivors)
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 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 Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claire Kelly
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College Dublin, Irish Research Council
- Responsible party
- Sponsor-investigator, Claire Kelly, Theya
- Investigators
- Amanda McCann, PhD, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593890
- Sponsor's protocol ID
- THEYARCT2015
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range
- ClinicalTrials.gov ID
- NCT02593890
- Acronym / sponsor ID
- THEYARCT2015
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Surgery, Mastectomy, Lumpectomy, Post-operative, Bra, Lingerie, Body Image
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Claire KellyIndustry (pharma, biotech, devices)
- Collaborators
- University College Dublin, Irish Research Council
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Nov 2015 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: THEYA Recovery RangeArm A: Participants will be fitted with the THEYA Recovery bra |
| Control | No intervention | –Arm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| THEYA Recovery RangePost-operative Lingerie made from viscose derived bamboo | Device | Intervention |
Primary outcome
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'
2 secondary outcomes
THEYA Recovery post-surgery bra impact on Body Image using The Body Image Scale (Hopwood et al, 2001)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
Amanda McCann, PhD contact
Amanda McCann, PhD study director
University College Dublin
Questions about this trial
What is this clinical trial studying?
A study testing THEYA Recovery Range in people with Breast Cancer, run by Claire Kelly.
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 5 inclusion and 5 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Claire Kelly, Masters of Science (00353833016223, claire@theya.healthcare), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 2 Nov 2015.