The effect of a lifestyle intervention on body weight, psychological health status and risk factors associated with disease recurrence in women recovering from breast cancer treatment

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN08045231
• Lead Sponsor: Sheffield Hallam University (UK)

Brief Summary

2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/16469108 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23184120 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24731917 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-25
• Study Completion: 2007-09-30
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Women who have undergone appropriate treatment for operable breast cancer within the past 3-18 months and are no longer undergoing chemotherapy or radiation therapy, will be recruited from the Cancer Research Centre, Weston Park Hospital, Sheffield University Hospitals NHS Trust
2. Postmenopausal women (confirmed by plasma estradiol and gonadotrophin measures in all women aged <55) with a body mass index (BMI) >25 and classified as disease stage I-III
3. Patients must have completed some form of breast cancer treatment at least three months, and not more than 18 months ago
4. Patients on Tamoxifen and other endocrine treatments but not hormone replacement therapy (HRT) will be included
5. Patients must be willing and able to attend supervised exercise sessions at least 3 times per week for a period of 24 weeks, with the intention of achieving an 80% minimum compliance target for attendance
6. Patients must be an exercise pre-contemplator, contemplator or preparer as defined by the Transtheoretical Model

Exclusion Criteria

1. Metastatic breast cancer patients and patients with inoperable or active loco-regional disease
2. Patients following alternative/complementary diets or taking high dose antioxidant supplements
3. Patients with a physical/psychiatric impairment that would seriously impair their physical mobility
4. Patients who are currently suffering from severe nausea, anorexia or other diseases affecting health (e.g. arthritis and multiple sclerosis)
5. HRT is not commonly prescribed in women who are recovering from breast cancer treatment, but use of HRT or oral contraceptives within the past four months is an exclusion criteria
6. Patients who are currently engaged in exercise (two or more times per week for at least 30 min per session during the previous 3 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight; body composition.

Secondary Outcome Measures

Name	Time	Method
Psychological health status; biomarkers associated with disease recurrence (including stress hormones, immune function, inflammatory mediators); quality of life; cardiovascular fitness.