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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Head and Neck Educational Handbook

• Registration Number: NCT02204631
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Study Start: 2014-08-12
• Primary Completion: 2016-12-22
• Study Completion: 2016-12-22
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Head and Neck Educational Handbook	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).

Primary Outcome Measures

Name	Time	Method
Information Satisfaction Questionnaire (ISQ)	Baseline, 4 Months, 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of participant change of scores of psychological distress	Baseline, 4 Months, 6 Months
Percentage of Participant illness perception	Baseline, 4 Months, 6 Months
Percentage of change participant symptom burden	Baseline, 4 Months, 6 Months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States