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

Dudley Group NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Behavioral: Physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02408107

ID800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Physical activity intervention

Experimental group

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.

Treatment:

Behavioral: Physical activity

Usual care

No Intervention group

Description:

This arm received usual care (i.e. no physical activity counselling, support phone calls or post-cards).