Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05306808 |
Other study ID # |
2017/00140 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 17, 2017 |
Est. completion date |
October 21, 2019 |
Study information
Verified date |
October 2021 |
Source |
National University Hospital, Singapore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The study recruits breast cancer survivors who are already on chemotherapy or are going to
start chemotherapy. Subjects will be asked for their preference to attend physiotherapy and
educational class (for intervention group) or decline for it (for control group).
For intervention group, subject will attend 24 sessions of physiotherapy (exercise class) and
10 sessions of educational class over 12 weeks. The supervised 1-hour group exercise class
will be conducted twice a week. Educational class will be once a week, with topics covering
physical activity, management of fatigue, lymphoedema, neuropathy, brain fog, return to work,
stress, nutrition, sexuality, psychosocial and caregiver issues.
Subjects in control group will be asked to exercise on their own in the 12 weeks.
12 weeks later, all subjects will attend a 2-hour survivorship transitional class, with
topics covering cancer surveillance and follow up, addressing fear of recurrence: symptom and
support, neuropathy/ fatigue/physical impairment/ brain fog, physical activity and diet,
screening for colorectal and cervical cancers, return to work and community resources. During
the class, a screening questionnaire will be administered to identify further physical,
rehabilitation and psychosocial needs and to triage these patients to relevant hospital and
community services.
Outcome assessment will be done at pre-intervention, after intervention, 6 months and 1 year
after the intervention.
Description:
This study will be a mixed study of both quantitative and qualitative research to investigate
the effect of the holistic program of combining patient education and intra chemotherapy on
cancer survivorship.
80 breast cancer survivors will be recruited from National University Cancer Institute,
Singapore (NCIS). Breast cancer survivors who are already on chemotherapy or are going to
start chemotherapy will be recruited.
Subjects will be asked their preference to attend physiotherapy and educational class (for
intervention group) or decline for it (for control group). The study is not randomized as
challenges in subject recruitment are expected otherwise. Patients in intervention group will
attend a program combining 24 sessions of physiotherapy and 10 sessions of educational class
over 12 weeks. Subjects in control group will be asked to exercise on their own.
The first visit for both groups will be an individual evaluation session by physiotherapist
(PT), occupational therapist (OT), and study coordinator. Baseline assessments of outcome
measures will be performed during the visit. PT and OT will also prescribe an individualized
home exercise program for subjects in both groups.
Subsequent visits for intervention group will be 24 sessions of physiotherapy (exercise
class) and 10 sessions of educational class over 12 weeks. The supervised 1-hour group
exercise class will be conducted twice a week, with a maximum of 8 patients in each class.
Subjects will be given a home log for exercise recording. If subjects are unable to attend
exercise class for any reason (eg., low counts or feeling unwell, etc.), they will be advised
to continue exercises at home. On the day of one of the exercise classes each week, there
will be an additional 1-hour group education/ discussion session which may be conducted by
PT, OT, APN, dietician or medical social worker. Topics covered will include physical
activity, management of fatigue, lymphoedema, neuropathy, brain fog, return to work, stress,
nutrition, sexuality, psychosocial and caregiver issues. There will be 10 sessions of
educational class in total for each subject.
After completing all exercise classes and educational classes for subjects in intervention
group, or after12 weeks' home exercise for subjects in control group, all subjects in both
group will attend a 2-hour survivorship transitional class, which will be held in groups of
up to 10 subjects. During the class, the trainer (usually APN) will educate and provide an
overview of breast cancer survivorship issues, seek to empower with self-assessment skills
and provide cancer survivors with information on available community resources. The class
seeks to reintegrate cancer survivors back to the community and will also serve as a platform
to screen for and identify those with further psychosocial and rehabilitation needs and
triage them accordingly to the relevant hospital or community resources. The topics that will
be covered in education will include cancer surveillance and follow up, addressing fear of
recurrence: symptom and support, neuropathy/ fatigue/physical impairment/ brain fog, physical
activity and diet, screening for colorectal and cervical cancers, return to work and
community resources. During the class, a screening questionnaire will be administered to
identify further physical, rehabilitation and psychosocial needs and to triage these patients
to relevant hospital and community services.
The subsequent 2 visits for both groups will be outcome assessment. One is after the
survivorship transitional class, and the other one is at 1 year after the survivorship
transitional class. Outcome measures will be administered by PT, OT, and study coordinator.