Feasibility, Acceptability and Preliminary Efficacy of the New Iteration of the Innovative Smartphone-based Care Solution for Women With Breast Cancer Undergoing Chemotherapy (iCareBreast+): A Pilot Study Research Proposal

Обзор

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: 1. To develop a new iteration of an innovative smartphone-based self-care solution for patients with breast cancer undergoing chemotherapy (iCareBreast+); 2. To assess the feasibility and acceptability of iCareBreast+; and 3. To explore the preliminary effects of iCareBreast+ on the primary outcome of self-efficacy, and knowledge of breast cancer treatment, as well as secondary outcomes including anxiety, depression, health-related quality of life (HRQoL), social support and satisfaction with oncologic care.

Подробное описание

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.

Вмешательства

• Другое Routine care
  Routine care provided by NCCS
• Другое Routine care + iCareBreast+ mobile app
  Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app

Первичные конечные точки

• The feasibility of research method and Intervention [Срок оценки: Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.]
• The acceptability of intervention [Срок оценки: After intervention (two months immediately post intervention)]
• The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy [Срок оценки: 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 [Срок оценки: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)]

Вторичные конечные точки (4)

• The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression [Срок оценки: 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 [Срок оценки: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)]
• The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy [Срок оценки: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)]
• The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care [Срок оценки: After Intervention (two months immediately post intervention)]

Критерии участия

Критерии включения

Women who:

• are the age of 21 years old and above at the point of recruitment;
• are diagnosed with stage 1-3 breast cancer;
• will undergo chemotherapy first time (initiating or up to #4 cycles of chemo is acceptable);
• can speak, read and write in English or Mandarin; and
• has access to and able to use smart phone.

Критерии исключения

Those who :

• are with a history of or concurrent other cancer types;
• have been suffering from psychiatric illness (e.g., schizophrenia), anxiety disorder or other mood disorder or impaired cognitive function;
• have alcohol or substance abuse within the previous year;
• are undergoing concurrent psychosocial interventions; and
• have been in the bereavement period in the last 6 months
• are in their pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 1 центр

• National Cancer Centre, Singapore — Singapore

Идентификаторы

NCT: NCT06977360 · iCareBreast+

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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