Clinical trial · Interventional
Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THEYA Recovery Range | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Arm A: Participants will be fitted with the THEYA Recovery bra
- interventionNames
- Device: THEYA Recovery Range
- type
- NO_INTERVENTION
- label
- Control
- description
- Arm B: Participants will be recommended or fitted with current recommended bra used in each hospital by the Breast Care Nurse Specialist
Primary outcomes (1)
- measure
- THEYA Recovery post-surgery bra impacted on the participant's quality of life using the 2009 EuroQol Group questionnaire EQ-5D-5L.
- timeFrame
- Four weeks
- description
- 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'
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available