Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving Quality of Life Through the Routine Use of the Patient Concerns Inventory for Head and Neck Cancer Patients (PCI-QoL)
Brief Summary: The Patient Concerns Inventory (PCI) for head and neck cancer (HNC) patients has been developed and used largely within the confines of a single clinic setting and has not been used routinely with patients in the first year following treatment. Research so far suggests it is popular with patients, they would like to continue to use it in clinic and it is feasible. Benefits of its routine repeated use is untested, notably its impact on improving QOL and in reducing emotional distress, especially within the first year after treatment when patients are more likely to benefit from repeated use of the PCI.

The overarching aim of the proposed research is to explore whether the routine use of the PCI in review clinics during the first year following head and neck cancer treatment can improve patients quality of life.

The primary outcome is an improvement in QOL. Secondary outcomes are:

social-emotional scale, distress thermometer and health economics.

This will be a pragmatic cluster randomised control trial with consultants randomised to either 'using or 'not using' the PCI at clinic. It will involve two centres. 416 patients from at least 10 consultant clusters are required to show a clinically meaningful difference in the primary outcome.

Intervention; Patient completion of the PCI and its inclusion into the regular review clinic consultation is the 'intervention' and is compared to standard out-patient follow-up. The pre-consultation questionnaires and PCI will be used from the first post-treatment clinic (i.e. baseline) onwards for one year. Completion of all pre-consultation questionnaires and the PCI is by computer (IPAD).


Options:
A: Arm Label: 1 frequent control; Type: ACTIVE_COMPARATOR; Interventions: Procedure: CT-scan, CEA, X-ray of lungs | Arm Label: 2 less frequent control; Type: OTHER; Interventions: Procedure: CT-scan, CEA, X-ray of lungs | Intervention Type: PROCEDURE; Name: CT-scan, CEA, X-ray of lungs; Assigned to Arm(s): 1 frequent control | Intervention Type: PROCEDURE; Name: CT-scan, CEA, X-ray of lungs; Assigned to Arm(s): 2 less frequent control
B: Arm Label: PCI Group; Type: OTHER; Interventions: Other: Patient Concerns Inventory | Arm Label: Non PCI Group; Type: OTHER; Interventions: Other: No Patient Concerns Inventory | Intervention Type: OTHER; Name: Patient Concerns Inventory; Assigned to Arm(s): PCI Group | Intervention Type: OTHER; Name: No Patient Concerns Inventory; Assigned to Arm(s): Non PCI Group
C: Arm Label: intervention group; Type: ACTIVE_COMPARATOR; Interventions: Device: distress thermometer | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: distress thermometer; Assigned to Arm(s): intervention group
D: Arm Label: Wait and Watch; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Therapeutic Neck Dissection | Arm Label: Elective Neck dissection; Type: EXPERIMENTAL; Interventions: Procedure: Elective neck dissection in early oral cancer | Intervention Type: PROCEDURE; Name: Elective neck dissection in early oral cancer; Assigned to Arm(s): Elective Neck dissection | Intervention Type: PROCEDURE; Name: Therapeutic Neck Dissection; Assigned to Arm(s): Wait and Watch

Answer: B