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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204631
• Other study ID #: 14-244
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: May 24, 2017
• Start date: August 12, 2014
• Est. completion date: December 22, 2016

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 22, 2016
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Head and Neck Educational Handbook

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participant change of scores of psychological distress		Baseline, 4 Months, 6 Months
Secondary	Percentage of change participant symptom burden		Baseline, 4 Months, 6 Months
Secondary	Percentage of Participant illness perception		Baseline, 4 Months, 6 Months