2 Phase Use Of Educational Materials In Head And Neck Cancer Center
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and Neck Cancer
Study Type
Study Phase
Study Design
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Name: Head and Neck Educational Handbook
Type: Other
Overall Status
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Status: Recruiting
Contact: Lori Wirth, MD - 617-724-4000 - LWIRTH@PARTNERS.ORG
Start Date
August 2014
Completion Date
July 2019
Massachusetts General Hospital
Massachusetts General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page