Trials / Completed
CompletedNCT05853614
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Quality of Life Intervention | Comprised of three components: (1) establishment of clinical research nurse (CRN) and patient relationship, (2) assessment and monitoring of physical, psychological, social, and spiritual well-being and patient-reported outcomes, and (3) weekly, interdisciplinary team meetings led by CRN. |
Timeline
- Start date
- 2023-04-15
- Primary completion
- 2025-04-15
- Completion
- 2025-04-15
- First posted
- 2023-05-11
- Last updated
- 2025-11-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05853614. Inclusion in this directory is not an endorsement.