Evaluation of Patient concerns using the Patients Concern Inventory (PCI) in Head Neck Radiation Oncology clinics: A longitudinal study

Head and Neck Squamous Cell Carcinoma (HNSCC) is one of the most common types of cancer in

India. It often occurs in areas like the mouth, voice box, and throat. These cancers can show different

symptoms depending on their location. Globally, cases of these cancers are increasing, and by 2050, it is

expected that 35 million new cancer cases will be diagnosed annually—a 77 percent rise compared to 2023. In

India, HNSCC affects people differently than in Western countries due to factors like earlier onset,

specific causes, and healthcare challenges like poverty, late detection, and limited access to treatment.

Treating head and neck cancers is complex because they involve various areas that require

different approaches. Treatment often combines surgery, radiotherapy, and chemotherapy, along with

support from teams specializing in speech therapy, physical therapy, quitting smoking, and nutrition.

Advances in treatment have improved survival rates, but they also bring long-term side effects. Since

these cancers occur near critical body parts, treatments can affect basic functions like eating, speaking,

and appearance. Surgery might cause visible scars, difficulty swallowing or speaking, or the loss of body

parts. Radiation therapy can lead to dry mouth, dental issues, changes in taste, and stiffness in the neck.

These challenges can significantly impact the daily lives of patients and survivors.

Understanding the needs of head and neck cancer patients is essential to providing quality care

and improving their lives. Often, patients struggle to share their problems with doctors because they

feel shy, don’t want to complain, or fear being a burden. As a result, some issues remain unaddressed.

To solve this, a tool called the Patient Concerns Inventory (PCI) was developed. This is a list of 56

common concerns that patients can select before meeting their doctor. It helps ensure that important

issues are not overlooked and allows healthcare professionals to address these concerns effectively.

The PCI–HN (specifically designed for head and neck cancer patients) helps patients

communicate their needs better and gives them more control over their health concerns. It also allows

doctors to direct their consultations and make referrals to other specialists when needed.

This study aims to understand the concerns of head and neck cancer patients in our context—

both when they start treatment and during follow-ups. This information will help doctors improve the

quality of consultations and identify patients who need extra support.

AIM AND OBJECTIVES

1. We aim to use PCI in our set of Head neck cancer patients to identify patient concerns and

improve patient care.

2. OBJECTIVE

2.1. Primary Objective: To document the concerns of patients coming for Radiation Oncology

consultations/ treatment for Head and Neck Cancers, at baseline and post treatment.

2.2. Secondary Objective:

A. To evaluate changes in their concerns during follow-up compared to their initial assessment.

B. To document any other concern (other than those mentioned in PCI) specific to Indian patients.

C. To personalize referrals for future patients using the PCI questionnaire

D. To measure prevalence of Return to Work amongst employed HNC patients and compare QoL

between those who RTW and those who do not RTW.

ENDPOINTS

1. PRIMARY ENDPOINT: To address the enumerated Concerns of patients coming for Radiation

Oncology consultation/ treatment with a curative intent in Head and Neck Cancers using the

Patients Concern Inventory (at diagnosis) module.

2. SECONDARY ENDPOINT: To address the enumerated concerns of patients post treatment in

head neck cancer patients using the PCI-HN post treatment module for a total duration of 1 year

post treatment.

STUDY DESIGN: Prospective longitudinal study to evaluate patient concerns using the Patients

Concern Inventory (PCI).

Inclusion Criteria: 1. Patients with histologically proven head and Neck Cancer

2. Patients treated with Curative Intent

3. Patients willing to sign the Informed Consent Form.

4. Literate Adult patients who are able to understand either English or Hindi will be included in

the study.

Exclusion Criteria: 1. Patients with synchronous or metachronous primaries or have received treatment for HN

cancers in the past.

2. Illiterate Patients who do not understand the PCI themselves.

3. Patients who do not sign the consent form

4. Patients who exclusively speak Marathi or other regional language and are unable to

understand either English or Hindi.

SAMPLE SIZE: To assess the longitudinal changes in patient concerns, we plan to enroll a convenient

sample of 300 individuals from head and neck Radiation Oncology clinics.