12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
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|ClinicalTrials.gov Identifier: NCT03518957|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Exercise||Phase 3|
In this study, 304 eligible patients will be randomized 1:1 to a 12-week exercise intervention program versus observation, and stratified by two factors: received adjuvant chemotherapy versus not, and age<50 versus age ≥50 years.
Breast cancer and its treatment can have both physical and psychological sequelae, which can persist many years after diagnosis. Physical effects include higher rates of pain, fatigue and decline in physical function, while psychological effects include depression and anxiety. In particular, depression spectrum syndromes occur in 20-50% of people with cancer, and in 1.5-46% of people with breast cancer. In a recent study conducted locally at the National University Cancer Institute, Singapore (NCIS), it was found that 27% of newly diagnosed cancer patients have caseness for depression and 44% have caseness for anxiety, as measured using the Hospital Anxiety and Depression scale. Breast cancer is also associated with weight gain - as many as 50-96% of women, especially those undergoing chemotherapy, experience sarcopenic weight gain during treatment, in the range of 2.5-6.2kg. Patients do not tend to return to their pre-diagnosis weight. With respect to quality of life (QoL), poorer QoL occurs in the short term, whereas long-term survivors tend to have a good overall QoL, albeit with an increase in some specific problems like lymphoedema and sexual dysfunction. Some of these measures predict overall survival and risk of recurrence - low levels of psychological distress and low fatigue independently predicted longer recurrence-free and overall survival, and lack of anxiety predicted longer recurrence-free survival. Obesity is also a poor prognostic factor and increases the risk of recurrence.
Telomere length (TL), which generally shortens with ageing, may also be implicated - in a study of breast cancer patients with or without insomnia, those with insomnia were reported to have higher rates of depression, fatigue and anxiety, and shorter TLs. Furthermore, breast cancer patients who were engaged in at least moderate physical activity had significantly longer TLs than those who did not, although there was no correlation between depression and shorter TLs in this study.Another study in prostate cancer patients showed that 3 months of comprehensive lifestyle changes after diagnosis was associated with increased telomere lengths and reduced telomerase activity after 5 years of follow-up.
To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Study of a 12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers|
|Actual Study Start Date :||March 12, 2015|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2025|
Experimental: Exercise intervention
Patients who are randomised to this arm will be enrolled to the exercise programme.
Week 1: Patients will undergo an introductory session where the occupational therapist will assess the general condition and physical fitness of the subjects.
Week 1 to Week 12: Group exercise sessions supervised by a physiotherapist, twice per week, each session lasting 1 hour, with no more than 8 participants in each group exercise session. The exercise regimen for each session will be personally tailored for the subjects, and will include stretching, cardiovascular and strength training, and cooling down exercises.
Week 12 onwards: Patients will receive phone calls- monthly for the first 6 months and then 3 monthly up to the 2-year mark, to encourage them to continue with their exercise regimen at home.
No Intervention: Non-exercise
Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would.
- Improved mental health [ Time Frame: 12 months ]Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of ≥8/21 as caseness for anxiety or depression
- Adherence rate [ Time Frame: 16 weeks ]Subjects are considered to have adhered to the 12-week exercise regimen if they have completed at least 20 scheduled sessions over a period of no longer than 16 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518957
|Contact: Soo Chin Lee||(65) 6779 email@example.com|
|Contact: Andrea Wong||(65) 6779 firstname.lastname@example.org|
|National University Hospital, Singapore||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Soo Chin Lee (65) 6779 5555 email@example.com|
|Tan Tock Seng Hospital||Recruiting|
|Singapore, Singapore, 308433|
|Contact: Ern Yu Tan +65 6357 7807 Ern_Yu_Tan@ttsh.com.sg|
|Principal Investigator: Soon-U Lawrence Lee|
|Ng Teng Fong General Hospital||Recruiting|
|Singapore, Singapore, 609606|
|Contact: Chuan Chien Tan +65 6716 2000 Chuan_Chien_Tan@nuhs.edu.sg|