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OpenTrials
Completed

NCT Number: NCT02204631

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Head and Neck Educational Handbook

Other

Primary outcomes

  1. Information Satisfaction Questionnaire (ISQ)

    Time frame: 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 outcomes

  1. Percentage of participant change of scores of psychological distress

    Time frame: Baseline, 4 Months, 6 Months

  2. Percentage of change participant symptom burden

    Time frame: Baseline, 4 Months, 6 Months

  3. Percentage of Participant illness perception

    Time frame: Baseline, 4 Months, 6 Months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2014
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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