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Table 3 List of CRANK research questions, associated outcomes, data collection tools, time point measurements and analysis plan

From: Study protocol for two pilot randomised controlled trials aimed at increasing physical activity using electrically assisted bicycles to enhance prostate or breast cancer survival

Research question

Outcome

Data collection method/tool

Time point of measurement

 

Analysis plan

Baseline (T0)

During intervention

Post (T1)

3-month FU (T2)

 

1. Can individuals with prostate/breast cancer be recruited into an e-cycling trial?

• No. of individuals in clinic; no. of meeting eligibility criteria; no. of express interest in participating

• Reasons for not wanting to participate in the study

• No. of individuals that consent to be part of the study

Study records

X

   

Frequencies and percentages

2. Are participants’ willing to be randomised, do they remain in the study and adhere to the intervention and data collection methods and what are the rates of harmful events?

• No. of participants retained in study following randomisation

• No. of individuals that complete follow-up testing

• No. of participants that attend each of the intervention sessions and data collection sessions

• No. of harmful events

Study records

 

X

  

Frequencies and percentages

3. Can the intervention be implemented as intended?

• No. of training sessions attended by participants and additional contact with instructors

• Extent to which intervention content is completed as planned

• No. of and extent of adaptations

Intervention checklists

 

X

  

Frequencies and percentages

4. Are the intervention and study procedures acceptable to participants, instructors and clinical team?

• Acceptability of recruitment strategy to clinical team

• Acceptability of intervention to participants

• Acceptability of study procedures to participants

• Acceptability of intervention delivery to instructors

Semi-structured interviews

  

X

 

Thematic analysis based on research question

5. What are participants experiences of e-cycling?

• Experiences of e-cycling

• Participant’s barriers and facilitators to e-cycling

Semi-structured interviews

  

X

 

Thematic analysis based on research question

6. What is the potential effect of the intervention on a range of individual health and behavioural outcomes?

• Weight, BMI and waist circumference

Tanita digital scales, SECA 700, non-stretch take

X

 

X

X

Comparison of change scores between conditions

Reporting of effect estimates with 95% CI

• Metabolic markers (fasting glucose, insulin, insulin resistance, lipid profile, IGF-I, IGF-II, IGFBP-2, IGFBP-3, PSAa)

8-mL blood sample

X

 

X

 

• General health-related quality of life

EuroQol-5 dimension-5 level

X

 

X

X

• Cancer-specific quality of life

EORTC QLQ-C30

EORTC PR-25a

EORTC BR-45b

X

 

X

X

• Urinary healtha

ICIQ-MLUTS

X

 

X

X

• Erectile dysfunctiona

International Index of Erectile Function

X

 

X

X

• Fatigue

FACIT-F

X

 

X

X

• Self-efficacy for coping with cancer

Cancer Behaviour Inventory — Brief

X

 

X

X

• Cardiorespiratory fitness

Maximum oxygen uptake using cycle ergometer

X

 

X

X

• Hand grip strength

Hydraulic hand dynamometer

X

 

X

X

• Total physical activity (time spent in moderate-to-vigorous physical activity)

Axivity AX3

X

 

X

X

Comparison of change scores between conditions

• Travel behaviour

• No. of trips

• Transport mode (walking, cycling, e-cycling, car, bus, train)

• Trip purpose

QStarz GPS and travel diary

X

 

X

X

Mean and SD

• E-cycling behaviour and intensity: no. of journeys, duration, distance travelled, purpose of use

Bike odometer, Fitbit Charge 5 GPS watch, logbook

 

X

  

Mean and SD

  1. aCRANK-P only, bCRANK-B only