Multidisciplinary Rehabilitation Programme for Breast Cancer

NCT05306808 | Completed

• 1 other identifier: 2017/00140
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (12)

• 6 minute walk test

  distance covered in 6 minutes with comfortable walking speed

  Week0

• 6 minute walk test

  distance covered in 6 minutes with comfortable walking speed

  Week12

• 6 minute walk test

  distance covered in 6 minutes with comfortable walking speed

  Month6

• 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

  Week0

• 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

  Week12

• 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

  Month6

• 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.

  Week0

• 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.

  Week12

• 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.

  Month6

• 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.

  Week0

• 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.

  Week12

• 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.

  Month6

Secondary Outcomes (3)

• International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  Week0

• International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  Week12

• International Physical Activity Questionnaire-Short Form (IPAQ-SF)

  Month6

Study Arms (2)

center-based exercise

EXPERIMENTAL

Participants in intervention group will attend a program combining 24 sessions of physiotherapy and 10 sessions of educational class over 12 weeks.

Other: physiotherapy class

exercise on his/her own

NO INTERVENTION

Participants in control group will be asked to exercise on their own, they will only attend 10 sessions of educational class over 12 weeks.

Interventions

physiotherapy class OTHER

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.

center-based exercise

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: Only females will be recruited
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Singapore Cancer Society: collaborator

Study Sites (1)

National Univerity Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 38509471 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Effie Chew

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: April 1, 2022
• Study Start: March 17, 2017
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: November 2, 2022

Record last verified: 2021-10

Locations

SG (1)