Clinical trial NCT02204631: 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
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Information Satisfaction Questionnaire (ISQ)
timeFrame: Baseline, 4 Months, 6 Months
Secondary outcomes:
measure: Percentage of participant change of scores of psychological distress
timeFrame: Baseline, 4 Months, 6 Months
measure: Percentage of change participant symptom burden
timeFrame: Baseline, 4 Months, 6 Months
measure: Percentage of Participant illness perception
timeFrame: Baseline, 4 Months, 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lori Wirth, MD
role: PRINCIPAL_INVESTIGATOR
References: