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Completed

NCT Number: NCT02408107

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Behavioral

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 outcomes

  1. Physical activity questionnaire (International Physical Activity Questionnaire)

    Time frame: Baseline and 6 months

    Change in self-reported physical activity (MET-min/wk) from baseline to post-intervention at 6 months in all 80 participants.

Secondary outcomes

  1. Health-related quality of life questionnaire (Functional Assessment of Cancer Therapy (FACT) - Breast)

    Time frame: Baseline and 6 months

    Change in health-related quality of life from baseline to post-intervention at 6 months in all 80 participants.

  2. Body mass

    Time frame: Baseline and 6 months

    Change in body mass (kg) from baseline to post-intervention at 6 months in all 80 participants.

  3. Body Mass Index

    Time frame: Baseline and 6 months

    Change in Body Mass Index (kg/m2) from baseline to post-intervention at 6 months in all 80 participants.

  4. Body fat percentage via bioelectrical impedance analysis

    Time frame: Baseline and 6 months

    Change in body fat percentage (%) from baseline to post-intervention at 6 months in all 80 participants.

  5. Glucose via venepuncture blood samples

    Time frame: Baseline and 6 months

    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.

  6. Insulin

    Time frame: Baseline and 6 months

    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.

  7. Insulin Resistance

    Time frame: Baseline and 6 months

    Change in insulin resistance (via Homeostasis Model Assessment) from baseline to post-intervention at 6 months in all 80 participants.

  8. Triglyceride

    Time frame: Baseline and 6 months

    Change in triglycerides (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.

  9. Total cholesterol

    Time frame: Baseline and 6 months

    Change in total cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.

  10. High-density lipoprotein cholesterol

    Time frame: Baseline and 6 months

    Change in high-density lipoprotein cholesterol (mmol) (via reflectance spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.

  11. Low-density lipoprotein cholesterol

    Time frame: Baseline and 6 months

    Change in low-density lipoprotein cholesterol (mmol) (dual chamber package and spectrophotometry) from baseline to post-intervention at 6 months in all 80 participants.

  12. Cardiorespiratory fitness

    Time frame: Baseline and 6 months

    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.

  13. Systolic blood pressure

    Time frame: Baseline and 6 months

    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.

  14. Diastolic blood pressure

    Time frame: Baseline and 6 months

    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.

  15. Mean Arterial Blood Pressure

    Time frame: Baseline and 6 months

    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.

  16. Resting heart rate

    Time frame: Baseline and 6 months

    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.

Sponsors and collaborators

Lead sponsor

Dudley Group NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PHAB

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2015
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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