Nurse-Led Quality of Life Study-Phase I

A Nurse-Led Intervention to Enhance Quality of Life Among Early Phase Clinical Trial Participants: A Pilot Study

The purpose of this study is to pilot test a brief, population-specific nurse-led, quality of life (QOL) intervention with early phase cancer clinical trial (EP-CT) participants.

The name of the intervention used in this research study is:

-Nurse-Led Quality of Life Intervention (comprised of nurse-patient relationship, assessment and monitoring of participant QOL, and interdisciplinary team meetings led by the CRN (clinical research nurse).

This is a single-site study evaluating the feasibility and acceptability as well as patient-reported and clinical outcomes of a nurse-led, quality of life intervention with EP-CT participants.

The research study procedures include obtaining consent to participate, meeting with research nurses monthly for three months, completing questionnaires, and an interview with the study staff at the end of the study.

Participation in this research study is expected to be for a total of six months.

It is expected that about 35 people, 25 caregivers, and 10 clinicians will take part in this research study.

The Oncology Nursing Foundation is supporting this research study by providing funding.

Patient Inclusion Criteria:

-> 18 years of age.

• Adults with cancer enrolled on an EP-CT in the Termeer Center at Massachusetts General Hospital.
• Able to read and respond to questions in English.

Caregiver Inclusion Criteria:

• A relative or friend of the eligible patient whom the patient identifies as being involved in their medical care.

  -> 18 years of age.

• Verbally fluent in English.

Clinician Inclusion Criteria:

• Clinician must be an oncology nurse.
• CRN for a minimum of 18 months.
• fulltime employee in the Termeer Center.