2 Phase Use Of Educational Materials In Head And Neck Cancer Center

NCT02204631 | Completed DMC

• 1 other identifier: 14-244
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Information Satisfaction Questionnaire (ISQ)

  The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.

  Baseline, 4 Months, 6 Months

Secondary Outcomes (3)

• Percentage of participant change of scores of psychological distress

  Baseline, 4 Months, 6 Months

• Percentage of change participant symptom burden

  Baseline, 4 Months, 6 Months

• Percentage of Participant illness perception

  Baseline, 4 Months, 6 Months

Study Arms (2)

Head and Neck Educational Handbook

EXPERIMENTAL

* Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception). * After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth. * Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).

Other: Head and Neck Educational Handbook

Non Head and Neck Educational Handbook

NO INTERVENTION

* Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception). * The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center. * Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception). * At completion of "Phase I", all 30 participants will also be given a copy of the handbook and an accompanying questionnaire.

Interventions

Head and Neck Educational Handbook OTHER

Head and Neck Educational Handbook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
• Patients who have a treatment plan including both chemotherapy and radiation.
• Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
• Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.

You may not qualify if:

• Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
• Patients who cannot speak, read and write in English with minimal assistance from a family member.
• Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
• Patients who will not be receiving their cancer treatment at MGH.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Lori Wirth, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 30, 2014
• Study Start: August 12, 2014
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

US (1)