A Home-based Physical Activity Intervention in Breast Cancer Survivors (PHAB)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Physical activity, Randomized controlled trial
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical activity intervention
Usual care
Arm Description
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.
This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Body mass
Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.
Body Mass Index
Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants.
Body fat percentage via bioelectrical impedance analysis
Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants.
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.
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.
Insulin Resistance
Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants.
Triglyceride
Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Total cholesterol
Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02408107
First Posted
March 25, 2015
Last Updated
April 12, 2015
Sponsor
Dudley Group NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02408107
Brief Title
A Home-based Physical Activity Intervention in Breast Cancer Survivors
Acronym
PHAB
Official Title
Randomised Controlled Trial of a Home-based Physical Activity Intervention in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dudley Group NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Physical activity, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity questionnaire (International Physical Activity Questionnaire)
Description
Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)
Description
Change in health-related quality of life from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Body mass
Description
Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Body Mass Index
Description
Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Body fat percentage via bioelectrical impedance analysis
Description
Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Glucose via venepuncture blood samples
Description
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.
Time Frame
Baseline and 6 months
Title
Insulin
Description
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.
Time Frame
Baseline and 6 months
Title
Insulin Resistance
Description
Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Triglyceride
Description
Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Total cholesterol
Description
Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
High-density lipoprotein cholesterol
Description
Change in high-density lipoprotein cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Low-density lipoprotein cholesterol
Description
Change in low-density lipoprotein cholesterol (mmol) (dual chamber package and spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.
Time Frame
Baseline and 6 months
Title
Cardiorespiratory fitness
Description
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.
Time Frame
Baseline and 6 months
Title
Systolic blood pressure
Description
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.
Time Frame
Baseline and 6 months
Title
Diastolic blood pressure
Description
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.
Time Frame
Baseline and 6 months
Title
Mean Arterial Blood Pressure
Description
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.
Time Frame
Baseline and 6 months
Title
Resting heart rate
Description
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.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian M Lahart, PhD
Organizational Affiliation
University of Wolverhampton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amtul R Carmichael, MD
Organizational Affiliation
Russells Hall Hopsital
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
24852599
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.
Results Reference
background
PubMed Identifier
25752971
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.
Results Reference
background
PubMed Identifier
19276838
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.
Results Reference
background
PubMed Identifier
18591167
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.
Results Reference
background
PubMed Identifier
15908668
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. doi: 10.1200/JCO.2005.03.080.
Results Reference
background
PubMed Identifier
21796050
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.
Results Reference
background
PubMed Identifier
17848814
Citation
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.
Results Reference
background
PubMed Identifier
17557948
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. doi: 10.1200/JCO.2006.07.9988.
Results Reference
background
PubMed Identifier
26988367
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.
Results Reference
derived
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A Home-based Physical Activity Intervention in Breast Cancer Survivors
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