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

NCT03518957 | Unknown Phase 3 DMC

• 1 other identifier: 2014/01283
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 3

Brief Summary

Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Improved mental health

  Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of ≥8/21 as caseness for anxiety or depression

  12 months

Secondary Outcomes (1)

• Adherence rate

  16 weeks

Study Arms (2)

Exercise intervention

EXPERIMENTAL

Patients who are randomised to this arm will be enrolled to the exercise programme.

Behavioral: Exercise

Non-exercise

NO INTERVENTION

Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would.

Interventions

Exercise BEHAVIORAL

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.

Exercise intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Only females will be included, as this is a study on breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age 21-70 years
• Histological or cytological diagnosis of breast carcinoma
• Stage I-III breast cancer
• Has undergone curative breast cancer surgery with no clinically measurable tumor
• Between 4-12 weeks from the last adjuvant radiotherapy or chemotherapy session, if given, whichever is later. Patients who do not receive adjuvant chemotherapy or radiotherapy can be enrolled and will be randomized within 4-12 weeks of breast cancer surgery.
• Able to sign informed consent
• Able to adhere to study procedures

You may not qualify if:

• Cardiovascular, respiratory, or musculoskeletal problems that preclude moderate physical activity
• Major medical problems deemed by the investigator to be unsuitable for enrollment

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (3)

National University Hospital, Singapore

Singapore, 119228, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

RECRUITING

Related Publications (2)

• Carayol M, Bernard P, Boiche J, Riou F, Mercier B, Cousson-Gelie F, Romain AJ, Delpierre C, Ninot G. Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol. 2013 Feb;24(2):291-300. doi: 10.1093/annonc/mds342. Epub 2012 Oct 5.

  PMID: 23041586 BACKGROUND

• Kolden GG, Strauman TJ, Ward A, Kuta J, Woods TE, Schneider KL, Heerey E, Sanborn L, Burt C, Millbrandt L, Kalin NH, Stewart JA, Mullen B. A pilot study of group exercise training (GET) for women with primary breast cancer: feasibility and health benefits. Psychooncology. 2002 Sep-Oct;11(5):447-56. doi: 10.1002/pon.591.

  PMID: 12228878 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Soo Chin Lee

CONTACT

(65) 6779 5555; soo_chin_lee@nuhs.edu.sg

Andrea Wong

CONTACT

(65) 6779 5555; andrea_la_wong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: May 8, 2018
• Study Start: March 12, 2015
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2025
• Last Updated: May 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)