A Home-based Physical Activity Intervention in Breast Cancer Survivors (PHAB)

Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity intervention; Received a 30 min physical activity counselling session which employed motivational interviewing to encourage the adoption of current recommended physical activity guidelines. This arm also received 3 support phone calls (1 at the end of months 1, 2 and 3) and a physical activity reminder postcard on months 4 and 5.	Behavioral: Physical activity; Physical activity (PA) intervention participants received a 30-45 min face-to-face consultation (1st visit), followed by 15-20 min support telephone calls (end of months 1, 2 and 3). During months 4 and 5 patients received reminder leaflets. Consultations were conducted by the primary researcher after baseline measurements and were based on the four core motivational interviewing principles. The topics covered in the consultation (e.g. goal setting, overcoming barriers, health and safety advice) were similar to other trials that incorporated a PA counselling component. The focus of the follow-up phone calls (end of months 1-3) was to prevent relapse and/or improve maintenance of PA. The intervention participants were encouraged to work towards accumulating at least 30min of moderate-intensity PA on 5-7 days/week.
No Intervention: Usual care; This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity questionnaire (International Physical Activity Questionnaire)	Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)	Change in health-related quality of life from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Body mass	Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Body Mass Index	Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Body fat percentage via bioelectrical impedance analysis	Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Glucose via venepuncture blood samples	Change in glucose (mmol/L) assessed using multi-layered slides with the Vitros® 5.1 FS chemistry system from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Insulin	Change in insulin (pmol/L) via a solid phase two-site chemi-luminescence immunometric assay with the Vitros® 5.1 FS chemistry system from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Insulin Resistance	Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Triglyceride	Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Total cholesterol	Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
High-density lipoprotein cholesterol	Change in high-density lipoprotein cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Low-density lipoprotein cholesterol	Change in low-density lipoprotein cholesterol (mmol) (dual chamber package and spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months
Cardiorespiratory fitness	Change in peak oxygen uptake (ml/min/kg) (via gas analysis during exercise tolerance test) from baseline to post-intervention at 6 months in 40% (32) of total recruited.	Baseline and 6 months
Systolic blood pressure	Change in systolic blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.	Baseline and 6 months
Diastolic blood pressure	Change in diastolic blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.	Baseline and 6 months
Mean Arterial Blood Pressure	Change in mean arterial blood pressure (mmHg) (via automated blood pressure sphygmomanometer) from baseline to post-intervention at 6 months in 40% (32) of total recruited.	Baseline and 6 months
Resting heart rate	Change in resting heart rate (beats/min) (via heart rate telemetry) from baseline to post-intervention at 6 months in 40% (32) of total recruited.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Dudley Group NHS Foundation Trust
• Investigators: Principal Investigator: Ian M Lahart, PhD, University of Wolverhampton; Study Director: Amtul R Carmichael, MD, Russells Hall Hopsital

Publications and helpful links

General Publications

• Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b.
• Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.
• 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.
• 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.
• Payne JK, Held J, Thorpe J, Shaw H. Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncol Nurs Forum. 2008 Jul;35(4):635-42. doi: 10.1188/08.ONF.635-642.
• Pinto BM, Frierson GM, Rabin C, Trunzo JJ, Marcus BH. Home-based physical activity intervention for breast cancer patients. J Clin Oncol. 2005 May 20;23(15):3577-87. doi: 10.1200/JCO.2005.03.080.
• Musanti R. A study of exercise modality and physical self-esteem in breast cancer survivors. Med Sci Sports Exerc. 2012 Feb;44(2):352-61. doi: 10.1249/MSS.0b013e31822cb5f2.
• Heim ME, v d Malsburg ML, Niklas A. Randomized controlled trial of a structured training program in breast cancer patients with tumor-related chronic fatigue. Onkologie. 2007 Sep;30(8-9):429-34. doi: 10.1159/000104097. Epub 2007 Sep 7.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 12, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Physical activity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ID800