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
| ISRCTN | ISRCTN08045231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08045231 |
| ClinicalTrials.gov number | NCT00689975 |
| Secondary identifying numbers | 05A008 |
- Submission date
- 24/08/2005
- Registration date
- 25/10/2005
- Last edited
- 24/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr John Saxton
Scientific
Scientific
Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom
| Phone | +44 (0)114 225 4414 |
|---|---|
| j.m.saxton@shu.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study objectives | 1. A dietary and exercise intervention will evoke a reduction in body weight in overweight or obese women who have undergone breast cancer treatment 2. A dietary and exercise intervention will evoke positive changes in indices of psychological health status and biomarkers associated with disease recurrence in overweight or obese women who have undergone breast cancer treatment |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Exercise and dietary intervention versus no intervention. |
| Intervention type | Other |
| Primary outcome measure | Body weight; body composition. |
| Secondary outcome measures | Psychological health status; biomarkers associated with disease recurrence (including stress hormones, immune function, inflammatory mediators); quality of life; cardiovascular fitness. |
| Overall study start date | 01/10/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 100 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom
S10 2BP
United Kingdom
Sponsor information
Sheffield Hallam University (UK)
University/education
University/education
City Campus
Howard Street
Sheffield
S1 1WB
England
United Kingdom
| Phone | +44 (0)114 225 5555 |
|---|---|
| liaison@shu.ac.uk | |
| Website | http://www.shu.ac.uk |
"ROR" |
https://ror.org/019wt1929 |
Funders
Funder type
Research organisation
American Institute for Cancer Research (USA) (ref: 05A008)
Government organisation / Research institutes and centers
Government organisation / Research institutes and centers
- Alternative name(s)
- American Institute for Cancer Research, Inc., AICR
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/02/2006 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 14/04/2014 | Yes | No | |
| Plain English results | 24/01/2022 | No | Yes |
Editorial Notes
24/01/2022: A link to plain English results was added.
