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

A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Head and Neck Educational Handbook

Detailed Description

There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head and Neck Educational Handbook; 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
No Intervention: Non Head and Neck Educational Handbook; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Lori Wirth, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2014
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Head and Neck Cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 14-244