RecruitingNot ApplicableNCT07116161

Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore

Pilot Study of Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore


Sponsor

National Cancer Centre, Singapore

Enrollment

100 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 21 Years

Inclusion Criteria18

  • Primary cohort (N=90):
  • Female
  • ≥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 or Mandarin
  • Willing to provide informed consent for the study participation
  • Exploratory cohort (N=10):
  • Female
  • ≥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 or Mandarin
  • Willing to provide informed consent for the study participation

Exclusion Criteria10

  • 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

Interventions

OTHERGraded Exercise Therapy Arm (GET)

Consists of a self-supervised individualized exercise prescription by the rehabilitation professional consisting of aerobic (e.g. brisk walking / cycling) and resistance training exercises, customized by patient preference.

OTHERExperimental: Exercise Therapy (GET) plus Cognitive Behavioural Therapy (CBT)

Consists of four major components adapted from previous studies,13,15,16 and delivered by qualified and trained study psychologists. First, the ABCD model of cognitive behavioural therapy (A: activating events, B: beliefs, C: consequences, D: Dispute) will be taught and applied to identify negative, unhelpful beliefs and the emotional, behavioural and physical consequences of those beliefs. Second, patients were taught behavioural strategies to manage fatigue (e.g. sleep hygiene, activity scheduling). Lastly, participants will be guided to reformulate dysfunctional cognitions regarding fatigue, improve coping strategies in relation to significant others (e.g. family, friends) and set goals.


Locations(4)

National Cancer Centre, Singapore (NCCS)

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

NCCS Satellite Clinic @ Changi General Hospital

Singapore, Singapore

NCCS Satellite Clinic @ Sengkang General Hospital

Singapore, Singapore

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NCT07116161


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