Table 2

Objects and outcome measures

ObjectivesOutcome measuresEndpoints
Primary objective
To assess the feasibility of conducting the ‘POLARiS’ trial
  1. Identify the recruitment rate to the cohort.

  2. Assess the characteristics of patients recruited to the cohort.

  3. Identify the prevalence of major LARS and onset from time of resection and time of radiotherapy.

  4. Identify the eligibility and conversion to recruitment in the RCT including proportions recruited to the three randomisation options.

  5. Describe the standard of care and variation across sites.

  6. Retention/adherence rate: compliance of patient to the treatment programme exploring potential crossover.

  7. Follow-up rate: willingness to complete and return outcome questionnaires and format of completion.

  1. Baseline, 3 months, 6 months, 9 months.

  2. Baseline, 3 months, 6 months, 9 months.

  3. 9 months.

  4. Baseline, 3 months, 6 months, 9 months.

  5. 12 months.

  6. 3 months, 6 months, 9 months, 12 months.

  7. Baseline, 3 months, 6 months, 9 months, 12 months.

Secondary objectives
Clinical and patient reported outcomes
  1. Patient reported LARS score, new LARS score variables, EORTC CR29 and QLQ 30, EQ-5D and MYMOP II at recruitment and every 3 months.

  2. Patient reported adverse events.

  3. Treatments offered, length of treatment, reasons for stopping.

  1. Baseline, 3 months, 6 months, 9 months, 12 months.

  2. Throughout study to 12 months.

  3. 3 months, 6 months, 9 months, 12 months.

  • EORTC, European Organisation for Research and Treatment of Cancer; LARS, low anterior resection syndrome; MYMOP, Measure Yourself Medical Outcomes Profile; QLQ, quality of life questionnaire.