Clinical trial NCT02408107: A Home-based Physical Activity Intervention in Breast Cancer Survivors
Official title: Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Physical activity
Randomized controlled trial
Lead sponsor: Dudley Group NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this current study was to investigate the effects of a pragmatic home-based physical activity programme on primarily physical activity levels and secondarily weight maintenance, health-related quality of life (HRQoL), insulin resistance (IR) and lipid concentrations in post-adjuvant therapy breast cancer survivors.

Detailed description: Due to the prevalence of treatment-related health concerns and increased risk of developing metabolic syndrome, recurrence and cardiovascular disease, breast cancer survivors may require diagnostic, therapeutic, supportive or palliative services for many years post-diagnosis. Encouraging breast cancer survivors to adopt a healthy lifestyle post-treatment may reduce the healthcare burden resulting from treatment-related sequelae and improve survival. In particular, higher levels of physical activity (PA) may positively influence some of these side-effects of treatment, enhance quality of life and reduce risk of recurrence and all-cause and breast cancer-related mortality. However, PA levels are generally low among breast cancer survivors and many women decrease their PA following diagnosis. Therefore, interventions are required to improve the post-diagnosis PA levels of breast cancer survivors.

Randomised controlled trials (RCTs) have found improvements in cardiorespiratory fitness, HRQoL, fatigue and weight maintenance in breast cancer survivors participating in PA interventions compared with control groups. However, most of these RCTs utilised facility-based interventions, which may limit their patients who have trouble accessing exercise facilities due to transportation or time-related difficulties. To overcome these problems home-based PA interventions have been investigated and have generally reported good adherence and positive effects on health, fitness and HRQoL outcomes. However, there is a lack of relevant interventions in the United Kingdom.

Eligibility criteria: Inclusion Criteria:

* Female 18 y and over,
* Diagnosed with invasive breast cancer (Stage I-III) within two years of enrolment and no evidence, or clinical suspicion, of metastatic disease,
* Post-surgery and had no surgery planned for the next six months at least,
* Had fully completed adjuvant therapy (radiotherapy and/or chemotherapy) not including hormonal therapy,
* No previous malignancy except in the case of ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), basal cell carcinoma or cervical carcinoma in situ, or where the patient has been disease-free for 10 years,
* No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up,
* Willing to be randomised, and willing to maintain contact with the investigators over the six months

Exclusion Criteria:

* No evidence of invasive breast cancer (i.e. only pre-invasive disease identified),
* Previous invasive breast cancer (surgically treated DCIS or LCIS is allowed),
* Inability to participate in PA because of severe disability (e.g. severe arthritic conditions), psychiatric illness and vulnerable subjects, such as pregnant women.
* Any other patient where PA was not approved by their oncologist due to the presence of one or more contraindications to exercise in cancer patients.

Primary outcomes:
measure: Physical activity questionnaire (International Physical Activity Questionnaire)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)
timeFrame: Baseline and 6 months
measure: Body mass
timeFrame: Baseline and 6 months
measure: Body Mass Index
timeFrame: Baseline and 6 months
measure: Body fat percentage via bioelectrical impedance analysis
timeFrame: Baseline and 6 months
measure: Glucose via venepuncture blood samples
timeFrame: Baseline and 6 months
measure: Insulin
timeFrame: Baseline and 6 months
measure: Insulin Resistance
timeFrame: Baseline and 6 months
measure: Triglyceride
timeFrame: Baseline and 6 months
measure: Total cholesterol
timeFrame: Baseline and 6 months
measure: High-density lipoprotein cholesterol
timeFrame: Baseline and 6 months
measure: Low-density lipoprotein cholesterol
timeFrame: Baseline and 6 months
measure: Cardiorespiratory fitness
timeFrame: Baseline and 6 months
measure: Systolic blood pressure
timeFrame: Baseline and 6 months
measure: Diastolic blood pressure
timeFrame: Baseline and 6 months
measure: Mean Arterial Blood Pressure
timeFrame: Baseline and 6 months
measure: Resting heart rate
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Wolverhampton
name: Ian M Lahart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Russells Hall Hopsital
name: Amtul R Carmichael, MD
role: STUDY_DIRECTOR
References:
citation: Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity levels in women attending breast screening, receiving chemotherapy and post-breast cancer treatment; a cross-sectional study. Int J Environ Res Public Health. 2014 May 20;11(5):5487-96. doi: 10.3390/ijerph110505487.
citation: Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9.
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citation: Lahart IM, Metsios GS, Nevill AM, Kitas GD, Carmichael AR. Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors. BMC Cancer. 2016 Mar 17;16:234. doi: 10.1186/s12885-016-2258-5.