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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02204631
Enrollment
60
Registered
2014-07-30
Start date
2014-08-12
Completion date
2016-12-22
Last updated
2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

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.

Interventions

OTHERHead and Neck Educational Handbook

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Information Satisfaction Questionnaire (ISQ)Baseline, 4 Months, 6 MonthsThe 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

MeasureTime frame
Percentage of participant change of scores of psychological distressBaseline, 4 Months, 6 Months
Percentage of change participant symptom burdenBaseline, 4 Months, 6 Months
Percentage of Participant illness perceptionBaseline, 4 Months, 6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026