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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special program led by nurses to improve the quality of life for cancer patients. It involves a close nurse-patient relationship, where nurses assess and monitor patients' well-being with support from a healthcare team. The trial seeks adults already participating in early-phase cancer trials at the Termeer Center who can speak English. Participants will fill out surveys, attend three on-site visits, and have exit interviews with their caregivers. Known as the Nurse-Led Quality of Life Intervention, this approach aims to help patients feel better supported during their cancer treatment journey. As an unphased trial, this study offers a unique opportunity to enhance the support system during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nurse-led intervention is safe?

Research has shown that cancer patients generally respond well to nurse-led care. One study found that this type of care can improve patients' quality of life without causing harm, successfully reducing symptoms like depression and anxiety.

Another study discovered that nurse-led programs benefit patients with advanced cancer who need extra care and comfort. These programs focus on personalized care, providing reassurance and support.

Overall, evidence suggests that nurse-led programs to improve quality of life are safe for patients, aiming to enhance well-being without adding risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse-Led Quality of Life Intervention because it shifts the focus from traditional medical treatments for cancer to enhancing the overall well-being of patients through personalized, nurse-led care. Unlike standard treatments that primarily target the cancer itself, this intervention aims to improve the quality of life for both patients and their caregivers by providing structured support and monitoring over time. The unique feature of this approach is the hands-on, personalized interaction with trained clinical research nurses, which includes regular surveys, on-site visits, and exit interviews designed to address the emotional and psychological aspects of living with cancer. This holistic approach has the potential to significantly enhance the overall care experience for patients and their families.

What evidence suggests that this nurse-led intervention is effective for improving cancer-related quality of life?

Studies have shown that nurse-led care can greatly improve the quality of life for cancer patients. For example, this care effectively manages constipation and trouble sleeping, common issues for people with cancer. Research also indicates that these approaches can alleviate financial problems and emotional stress. Additionally, nurse-led care boosts coping skills and enhances daily functioning and roles. These findings suggest that such care can significantly impact the everyday lives of cancer patients. Participants in this trial will receive a Nurse-Led Quality of Life Intervention to further explore these benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Debra Lundquist, PhD, RN

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30142854/

Nurse-led interventions on quality of life for patients with ... Conclusion: The nurse-led disease management strategy seemed to be effective to improve constipation, insomnia, and financial impacts for patients with cancer ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925001117

The effect of nurse-led enhanced supportive care as an ... Nurse-led enhanced supportive care as an early primary palliative care approach improved the role functioning domain of quality of life, use of coping ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12577444/

Effectiveness of nurse-led mHealth interventions on symptom ... The study examines nurse-led mHealth interventions for managing cancer-related physical and psychological symptoms. A nurse-led mHealth ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772632022000411

The effectiveness of nurse-led interventions for cancer ... Data pooled from these six trials demonstrated that nurse-led interventions had a significantly beneficial effect on constipation in people with cancer compared ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1650066/full

Impact of personalized nursing on the quality of life in lung ... Our study provides strong evidence that a personalized, nurse-led intervention model significantly enhances QoL, reduces emotional distress, improves treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6112931/

Nurse-led interventions on quality of life for patients with cancer To compare the quality of life outcome between nurse-led and non-nurse-led interventions for patients with cancer using a meta-analysis.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1462388921000673

Providing a nurse-led complex nursing INtervention ... The intervention. The INFO-QoL intervention aimed at improving patients' outcomes and overall QoL in advanced-disease cancer patients with palliative care needs ...

8. journals.lww.com journals.lww.com/md-journal/fulltext/2018/08240/nurse_led_interventions_on_quality_of_life_for.106.aspx

Nurse-led interventions on quality of life for patients... To compare the quality of life outcome between nurse-led and non-nurse-led interventions for patients with cancer using a meta-analysis.

9. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-025-03981-2

Effectiveness of nurse-led mHealth interventions on symptom ... Nurse-led mHealth interventions show promising effects in improving symptom severity, depression, anxiety, and quality of life among patients ...