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Table 1 Study procedures and outcome measures collected at baseline and/or six-month follow-up assessments

From: A text message intervention to support women’s physical and mental health after breast cancer treatments (EMPOWER-SMS): a randomised controlled trial protocol

 

Baseline

Six-months (+/−  4 weeks)

Informed Consent

 

Inclusion/Exclusion Criteria

 

Demographics

 

Medical history (from hospital file)

 

Medication adherence (self-reported)

Accelerometer provided (n = 32)

Primary outcome

 Self-efficacy - Self-Efficacy to Manage Chronic Disease Scale (6-items) [35]

Secondary outcomes

 BMI measured by height in cm by stadiometer and weight in kilograms [36]

 Total body fat percentage measured with Seca medical Body Composition Analyser (mBCA) 515 with Seca Analytics mBCA 115 software (Seca GmbH & Co. KG, Hamburg, Germany) [37]

 Waist circumference in cm [36]

 Physical activity level – GPAQ, a validated measure of mild, moderate and vigorous intense activity, as well as sedentary behaviours [38].

 Nutrition - Questions adapted from WHO STEPS [39, 40]

 Quality of life – measured by a core 30-item quality of life questionnaire, EORTC QLQ-30 AND

23-item breast cancer-specific sub-scale EORTC QLQ-BR23, which have been widely used and validated in breast cancer populations [41]

 Illness perceptions – BIPQ, a validated 9-item measure used to rapidly assess patients’ perceptions of the cognitive and emotional impacts of their illness, including disease severity and causality [42].

 Depression and Anxiety - short-form DASS, which has been validated and tested in numerous patient populations [43]. This scale will be collected from participants’ medical file, unless the scale was completed more than one month prior to the study visit, then participants will complete the scale.

 Randomisation

 

Participant feedback survey

 

  1. BMI Body Mass Index, WHO STEPS, World Health Organisation STEPwise approach to chronic disease risk factor surveillance; EORTC QLQ-30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core; EORTC QLQ-BR23 Breast Cancer subscale; GPAQ Global Physical Activity Questionnaire; BIPQ Brief Illness Perception Questionnaire; DASS Depression Anxiety Stress Scale