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Breast CancerNCT05306808

Multidisciplinary Rehabilitation Programme for Breast Cancer

A study testing physiotherapy class in people with Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 21 to 80 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
physiotherapy class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSingapore
Study dates
17 Mar 2017to 21 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females between 21 - 80 years old;
  • Breast cancer patients before or already on the treatment of chemotherapy, targeted therapy, and/or radiotherapy;
  • Be able to provide consent and complete questionnaires;
  • Be able to walk independently in the community without use of gait aids.
  • Breast cancer patients who are suitable for exercise.

Who cannot join

  • Pregnant;
  • Uncontrolled hypertension (Resting BP >160/90 mm Hg), or history of recurring or persistent hypotension in the past 2 months;
  • History of recent myocardial infarction or unstable angina (within the past 6 months);
  • Significant valvular disease i.e. severe aortic stenosis and moderate-severe mitral regurgitation;
  • Patient with end stage organ disease (e.g. ESRF, end stage COPD);
  • Tumor infiltration of axial or weight-bearing bones with risk of pathological fractures or compression of the spinal cord;
Show all 10Show fewer
  • Patient with recent stroke within the past 6 months;
  • With other neuromusculoskeletal disorders such as osteoarthritis of such severity as to limit ability to participate in group exercise classes;
  • Already participating in regular physical activity (150min of moderate or 75min of vigorous physical activity/week);
  • Deemed inappropriate by primary oncologists.

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • National Univerity Hospital

    Singapore

Other trials in Singapore

About this study

Official title: Feasibility and Efficacy Study of Multidisciplinary Breast Cancer Rehabilitation During Chemotherapy

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.

Read more

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.

Read the detailed 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.

Conditions
Breast Cancer
Being tested
physiotherapy class
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physiotherapy classOther

    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 xercises 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.

Study groups in NCT05306808
Study groupRoleWhat they receive
center-based exerciseExperimentalParticipants in intervention group will attend a program combining 24 sessions of physiotherapy and 10 sessions of educational class over 12 weeks.
Receives: Other: physiotherapy class
exercise on his/her ownNo interventionParticipants in control group will be asked to exercise on their own, they will only attend 10 sessions of educational class over 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 minute walk test

    distance covered in 6 minutes with comfortable walking speed

    Measured: Week0

  2. 6 minute walk test

    distance covered in 6 minutes with comfortable walking speed

    Measured: Week12

  3. 6 minute walk test

    distance covered in 6 minutes with comfortable walking speed

    Measured: Month6

  4. Frenchay Activities Index (FAI)

    measure of engagement in instrumental activities of daily living. The scale provides a summed score from 15-60. Higher FAI score indicates higher instrumental activities

    Measured: Week0

  5. Frenchay Activities Index (FAI)

    measure of engagement in instrumental activities of daily living. The scale provides a summed score from 15-60. Higher FAI score indicates higher instrumental activities

    Measured: Week12

  6. Frenchay Activities Index (FAI)

    measure of engagement in instrumental activities of daily living. The scale provides a summed score from 15-60. Higher FAI score indicates higher instrumental activities

    Measured: Month6

  7. Functional Assessment of Cancer Therapy scale (FACT)-fatigue

    Fatigue scale, All items are summed to create a single fatigue score with a range from 0 to 52. Higher score indicates better outcome.

    Measured: Week0

  8. Functional Assessment of Cancer Therapy scale (FACT)-fatigue

    Fatigue scale, All items are summed to create a single fatigue score with a range from 0 to 52. Higher score indicates better outcome.

    Measured: Week12

  9. Functional Assessment of Cancer Therapy scale (FACT)-fatigue

    Fatigue scale, All items are summed to create a single fatigue score with a range from 0 to 52. Higher score indicates better outcome.

    Measured: Month6

  10. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Measurement on quality of life. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.

    Measured: Week0

  11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Measurement on quality of life. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.

    Measured: Week12

  12. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Measurement on quality of life. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.

    Measured: Month6

Secondary outcomes (3)
  1. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ-SF requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days.

    Measured: Week0

  2. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ-SF requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days.

    Measured: Week12

  3. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ-SF requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days.

    Measured: Month6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2022
  2. Study start17 Mar 2017
  3. Primary completion21 Oct 2019
  4. Study completion21 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants in the intervention group will attend a program combing 24 sessions of physiotherapy and 10 sessions of educational class over 12 weeks. Participants in the control group will be asked to exercise on their own.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05306808
Sponsor's protocol ID
2017/00140
Other IDs
2017
Status last verified
Oct 2021
First submitted
7 Jun 2021
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chandran G, Tang N, Ngo ELP, Huang S, Tong SI, Ong JX, Chew E. Comparing the efficacy of a multi-dimensional breast cancer rehabilitation programme versus a home-based exercise programme during adjuvant cancer treatment. BMC Cancer. 2024 Mar 21;24(1):361. doi: 10.1186/s12885-024-12080-5.

    PubMed 38509471

Questions about this trial

What is this clinical trial studying?

A study testing physiotherapy class in people with Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 minute walk test (time frame: Week0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05306808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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