Table 1. Schedule of enrolment, interventions and assessments of the PECAN trial.
| Timepoint | Study period | |||||||
|---|---|---|---|---|---|---|---|---|
| Enrolment | Allocation | Post-allocation | ||||||
| -t2 Referral |
-t1 telephone consult |
0 | t1 baseline |
t2 6 weeks after baseline |
t3 12 weeks after baseline |
t4 6 Mo after baseline |
t5 12 Mo after baseline |
|
| Enrolment | ||||||||
| Eligibility screen | X | |||||||
| Informed consent | X | |||||||
| Randomisation | X | |||||||
| Allocation | X | |||||||
| Interventions | ||||||||
| Education | PA coaching | |||||||
| eHealth intervention | n=90 | x | x | |||||
| Face-to-face intervention | n=90 | x | x | |||||
| Usual care | n=90 | |||||||
| Assessments | ||||||||
| Pain-related disability (primary outcome)* | X | X | X† | X | ||||
| Pain-related outcomes, including pain beliefs and attitudes (key secondary outcome)* | X | (X)† | X | X | X | |||
| Physical outcomes* | X | X | X | X | ||||
| Psychosocial outcomes* | X | X | X | X | ||||
| Health economic outcomes* | X | X | ||||||
See online supplemental appendix C for details on the content of the different assessments at each point in time.
Primary endpoint of the trial.
The key secondary outcome ‘pain beliefs and attitudes’ is the only outcome collected at 6 weeks.
PA, physical activity; PECAN, Pain Education and Coaching of Activity Needs in breast cancer survivors.