Pilot Study of Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Willingness to Pay for Therapy Sessions
研究概览
简要总结
The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.
详细描述
This is a randomized controlled, pilot intervention study enrolling 100 female breast cancer patients recruited from National Cancer Centre Singapore, Singapore General Hospital, NCCS Satellite Clinic @ Sengkang General Hospital, and NCCS Satellite Clinic @ Changi General Hospital.
Participants who are deemed eligible by their attending healthcare professional or indicate fatigue on the distress thermometer scale will be referred to the study research assistants or study investigators for further screening. Study research assistants or study investigators will use the Citrix SCM and OAS platform to review patient medical records and appointments.
The study research assistants or study investigators will screen participants based on the study's inclusion and exclusion criteria. They will then approach eligible participants during their clinic appointments or via telephone to introduce the study to them. Interested participants will be further screened and will be asked, "How would you rate your fatigue on a scale of 0 to10 with 0 being 'no fatigue' and 10 being the 'worst possible fatigue'?" (One-item fatigue scale score). The study research assistants or study investigators will record the one-item fatigue scale score for the healthcare professional to review.
If the participant is screened to be eligible, the consent process will be done in clinic or at the participant's home by research assistants and/or study investigators. This will take place either on the same day as their clinic appointment or at another mutually agreed upon date and time in a quiet and conducive room as far as possible. During the consent process, patients are given ample opportunity to ask questions. Participants will be given sufficient time to consider their willingness to participate in the study. Participation in the study will be entirely voluntary. All participants will provide written informed consent prior to their participation in the study.
After obtaining consent, recruited patients will be asked to complete the registration form. They will then be randomized 1:1 into either an exercise therapy arm or an exercise therapy plus CBT arm. They will then complete the baseline questionnaire and the 3 physical function tests, which will be conducted either by a rehabilitation professional, trained research assistant or study investigator. Afterwards, participants will commence the 12-week intervention they have been randomized into (exercise therapy or exercise therapy and CBT). Exercise therapy and CBT will each consist of up to four 1-hour telemedicine sessions using Zoom over 12 weeks, focusing on physical activity and psychosocial elements. The exercise therapy and CBT telemedicine sessions will be arranged at a mutually agreed upon date and time. Follow up visits will be conducted face-to-face in person at the study's site clinics or at the participant's home at a mutually agreed upon date and time at 3 months (Time 1), 6 months (Time 2) and 12 months post-enrolment (Time 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary cohort (N=90):
- •≥21 years of age
- •Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
- •Completed surgery
- •Completed adjuvant chemotherapy, if indicated
- •Reported fatigue (One-item fatigue scale score ≥ 4)
- •Ability to read and communicate in English
- •Willing to provide informed consent for the study participation
- •Exploratory cohort (N=10):
- •≥21 years of age
- •Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status
- •Completed surgery
- •Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy)
- •Reported fatigue (One-item fatigue scale score ≥ 4)
- •Ability to read and communicate in English
- •Willing to provide informed consent for the study participation
排除标准
- •for both cohorts:
- •Pregnant or lactating
- •Presence of dementia or major psychiatric disease
- •Deemed medically unsuitable by medical team for low to moderate intensity exercise
- •Unable or unwilling for tele-counselling sessions
- •Uncontrolled pain or undiagnosed pain
- •Low blood counts: Hb <8.0, Platelet <50K, ANC <1
- •Electrolyte imbalances: K <3.0, Na <130
- •Cardiovascular diseases, including but not limited to: LVEF <35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist
- •Active infection
- •Currently engaged in moderate to vigorous physical activity
研究组 & 干预措施
Graded Exercise Therapy Arm (GET)
干预措施: Graded Exercise Therapy Arm (GET) (Other)
Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)
干预措施: Experimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT) (Other)
结局指标
主要结局
Willingness to Pay for Therapy Sessions
时间窗: 3 Months post-enrolment.
* Measured using a 10-item custom survey based on a step-wise price-point method ($130, $100, $75, $50, $30 per session) to reflect a range of rates covering private and subsidized rates of different tiers. * Participants respond with binary Yes/No options, followed by questions assessing willingness to participate if costs are covered by Medisave. * This allows estimation of maximum willingness to pay under both cash and insurance-covered scenarios.
Client Satisfaction with Exercise Therapy and Cognitive Behavioural Therapy (CBT)
时间窗: Up to 12 months post-enrolment.
Measured using a 8-item Client Satisfaction Questionnaire. Each item is rated on a 4-point scale, with higher scores indicating greater satisfaction.
Perceived Cultural Sensitivity of the Intervention
时间窗: Up to 12 months post-enrolment.
Measured using 4 items adapted from the Cultural Sensitivity Assessment Tool. Each item is rated on a 4 point-scale (1 = Strongly Disagree, 4 = Strongly Agree) with higher scores indicating greater cultural sensitivity.
Uptake and Adherence to Exercise Therapy and Cognitive Behavioural Therapy (CBT)
时间窗: 3 Months post-enrolment.
Measured using the percentage of randomized patients who attended at least one session of their allocated intervention and the percentage of randomized patients who completed their allocated interventions.
次要结局
- Preliminary Effectiveness (Fatigue)(Up to 12 months post-enrolment.)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire (GLTPAQ)(Up to 12 months post-enrolment.)
- 6-Minute Walk Test (6MWT)(Up to 12 months post-enrolment.)
- 5 Times Sit-to-Stand Test (5xSTS)(Up to 12 months post-enrolment.)
- Adherence to Breast Cancer Treatments(Up to 12 months post-enrolment.)
- Quality of Life (QoL)(Up to 12 months post-enrolment.)
- Handgrip Strength (HGS)(Up to 12 months post-enrolment.)