Nurse-Led Intervention for Cancer-Related Quality of Life

Overseen By Debra Lundquist, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-cancer, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Debra Lundquist, PhD, RN

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with cancer enrolled in early phase clinical trials at the Termeer Center, Massachusetts General Hospital. Participants must be 18+, fluent in English, and have a close person involved in their care. Oncology nurses participating need to have worked as a CRN for at least 18 months.

Inclusion Criteria

I am 18 or older, have cancer, and can read and answer questions in English.

Clinicians: Must be an oncology nurse, CRN for a minimum of 18 months, Full-time employee in the Termeer Center.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nurse-led quality of life intervention, including monthly meetings with research nurses and completion of surveys

3 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in quality of life, depression, anxiety, and other outcomes

3 months

Long-term follow-up

Participants' utilization of supportive care services and survival are monitored

Up to 2 years

Treatment Details

Interventions

• Nurse-Led Quality of Life Intervention

Trial Overview The study tests a nurse-led intervention aimed at improving quality of life (QOL) for cancer patients. It involves building nurse-patient relationships, regular QOL assessments, and interdisciplinary team meetings coordinated by the clinical research nurse.

Participant Groups

Group I: Nurse-Led Quality of Life Intervention Experimental Treatment 1 Intervention

Participants and caregivers will complete study procedures as outlined: * Completion of surveys at four timepoints (baseline, one month, two months, and three months) * Three visits on-site with trained clinical research nursing staff. * Semi-structured exit interviews with participants and caregivers.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Oncology Nursing Society

Collaborator

Trials

11

Recruited

510+