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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Head and Neck Educational Handbook
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Head and Neck Educational Handbook

Non Head and Neck Educational Handbook

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of participant change of scores of psychological distress
Percentage of change participant symptom burden
Percentage of Participant illness perception

Full Information

First Posted
July 29, 2014
Last Updated
May 24, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02204631
Brief Title
2 Phase Use Of Educational Materials In Head And Neck Cancer Center
Official Title
A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Head and Neck Educational Handbook
Arm Type
Experimental
Arm Description
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).
Arm Title
Non Head and Neck Educational Handbook
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Head and Neck Educational Handbook
Primary Outcome Measure Information:
Title
Information Satisfaction Questionnaire (ISQ)
Description
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.
Time Frame
Baseline, 4 Months, 6 Months
Secondary Outcome Measure Information:
Title
Percentage of participant change of scores of psychological distress
Time Frame
Baseline, 4 Months, 6 Months
Title
Percentage of change participant symptom burden
Time Frame
Baseline, 4 Months, 6 Months
Title
Percentage of Participant illness perception
Time Frame
Baseline, 4 Months, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Wirth, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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