A Home-based Physical Activity Intervention in Breast Cancer Survivors

Breast Cancer Clinical Trial

— PHAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408107
• Other study ID #: ID800
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2015
• Last updated: April 12, 2015
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2015
• Source: Dudley Group NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dudley Group NHS Foundation Trust

References & Publications (8)

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. Epub 2007 Sep 7. — View 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. — View 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Body mass	Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Triglyceride	Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.	Baseline and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No