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| Name | Class |
|---|---|
| Buddy Healthcare Ltd OY | UNKNOWN |
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The overall aim of the study is to evaluate the feasibility, acceptability and preliminary effects of the next iteration of iCareBreast+, an innovative breast care e-support intervention programme, by refining existing contents and building new contents based on comprehensive assessment of breast cancer women's needs and preferences among breast cancer patients undergoing chemotherapy.
The specific objectives of this study are:
A two-group pilot randomized controlled trial with pretest and post-test will be conducted in a tertiary hospital in Singapore. Women with breast cancer requiring chemotherapy (n = 40) will be recruited and randomly allocated to the intervention group (receiving iCareBreast+ and routine care) or the control group (routine care only). Feasibility data (patient recruitment and attrition, usefulness, ease of use, strengths and weaknesses), as well as app quality data will be collected. Health outcomes will be measured using validated instruments at baseline and immediately after the 2-month intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental |
| |
| Intervention Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care | Other | Routine care provided by NCCS |
| |
| Routine care + iCareBreast+ mobile app |
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility of research method and Intervention | Participants recruitment and attrition rates. | Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later. |
| The acceptability of intervention | Process evaluation (semi-structured interview) and app quality (mobile app rating scale score) | After intervention (two months immediately post intervention) |
| The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy | Changes of Self-efficacy Score (Self-efficacy Score from the cancer Behaviour Inventory-Brief (CBI-B) survey). | Baseline (on enrolment day), and after Intervention (two months immediately post intervention) |
| The impact of psychosocial Intervention (iCareBreast+ app) on knowledge of breast cancer treatment | Changes of knowledge Score (Knowledge Score from a scale of 0-10) | Baseline (on enrolment day), and after Intervention (two months immediately post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression | Changes of anxiety and depression Score (Hospital Anxiety and Depression scale). | Baseline (on enrolment day), and after Intervention (two months immediately post intervention) |
| The impact of psychosocial Intervention (iCareBreast+ app) on cancer related quality of life |
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Inclusion Criteria:
Women who:
Exclusion Criteria:
Those who :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed | Contact | +65 64368000 | ryan.shea.tan.y.c@singhealth.com.sg | |
| Bernard JG Chua, MBBS (Hons)(Aus), MRCP (UK) | Contact | +65 64368000 | bernard.chua.j.g@singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre, Singapore | Recruiting | Singapore | Singapore |
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| Other |
Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app |
|
Changes of Cancer related quality of lief Score (Functional Assessment of Cancer Therapy-Breast (FACT-B)) |
| Baseline (on enrolment day), and after Intervention (two months immediately post intervention) |
| The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy | Changes of Social support Score (The Medical Outcomes Study Social Support Survey). | Baseline (on enrolment day), and after Intervention (two months immediately post intervention) |
| The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care | Satisfaction Score (Satisfaction Score from a single item 6-point Ordinal Descriptive Scale). | After Intervention (two months immediately post intervention) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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