Nurse-Led Education for Advanced Cancer

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Severe mental illness, Hospice, Non-English

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

Compensation: Varies

Number of Visits: 11

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special program led by nurses to help patients with advanced cancer manage their worries and fears about the future. It aims to determine if this nurse-led intervention, which includes videoconference sessions and activities like mindfulness and goal setting, is effective and can be easily implemented in hospitals and clinics. The trial seeks participants with stage III or IV gynecologic or lung cancer, who have been diagnosed for at least three months, and are experiencing significant fear about their cancer progressing. As an unphased trial, this study offers patients the chance to contribute to innovative care strategies that could enhance emotional well-being for others in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that nurse-led programs are safe and well-received by cancer patients. Many studies have examined these programs and found them effective without causing harmful side effects. For instance, one study on managing fear of cancer progression found these programs practical and acceptable, allowing patients to participate without major problems.

Another study examined how these programs help with cancer symptoms and found similar positive results. Designed to assist with coping and managing symptoms, these programs have benefited patients' overall well-being.

In summary, nurse-led programs have been tested in different settings and are safe. They offer support without risking patients' health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nurse-led intervention for advanced cancer care because it offers a fresh approach to managing the emotional and psychological side of the disease. Unlike standard treatment options that primarily focus on medical interventions like chemotherapy or radiation, this method emphasizes worry management skills, values-based goal setting, and mindfulness practices through interactive videoconference sessions. This approach not only supports patients' mental well-being but also empowers them to play an active role in their treatment journey. By integrating these techniques, the intervention aims to enhance overall quality of life and provide comprehensive supportive care.

What evidence suggests that this nurse-led intervention is effective for coping with advanced cancer?

This trial will evaluate a Nurse-Led Intervention, which includes supportive care through videoconference sessions and patient workbook activities. Studies have shown that nurse-led programs can effectively help cancer patients manage symptoms and improve overall well-being. Research indicates that these programs, often including education and coping strategies, help patients handle stress and anxiety better. One study found that regular health coaching sessions led by nurses improved health and emotional outcomes for cancer patients. Another study highlighted how nurse-led approaches enhanced patients' understanding and management of their conditions. These findings suggest that education provided by nurses is a valuable tool for supporting cancer patients in managing health challenges. ^{2 3 4 6 7}

Who Is on the Research Team?

Anne Reb

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with stage III or IV lung or gynecologic cancer, who have been diagnosed at least 3 months ago and are experiencing significant fear about their cancer progressing, as shown by a score of 34 or higher on a specific questionnaire. It's not suitable for those in hospice care or with severe mental illnesses like psychosis.

Inclusion Criteria

You were diagnosed at least 3 months ago.

You have advanced gynecologic or lung cancer.

Your score on the Fear of Progression-short form questionnaire is 34 or higher.

Exclusion Criteria

Hospice enrolled

Non-English speaking

You have a serious mental illness like psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a nurse-led intervention with 5 videoconference sessions over 6 weeks, focusing on worry management skills, values-based goal setting, and mindfulness practices.

6 weeks

5 videoconference sessions

Follow-up

Participants complete surveys and questionnaires to assess the intervention's impact on fear of progression, anxiety, depression, and mindfulness.

4 weeks

Questionnaires at baseline, 6 weeks, and 10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Nurse-Led Intervention

Trial Overview The study tests an educational program led by nurses aimed at helping advanced cancer patients manage their fears and uncertainties about the future. The goal is to see if this approach can improve coping strategies and whether it's feasible in medical centers and community clinics.

How Is the Trial Designed?

Group I: Supportive care (videoconference, questionnaire, survey) Experimental Treatment 1 Intervention

Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258200/

A Cross-Sectional Study on the Impact of Nurse-Led Health ... This study investigates the association between the frequency of health coaching sessions and key clinical and psychosocial outcomes among cancer patients.

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

The effectiveness of nurse-led interventions for cancer ... This study aimed to identify, appraise and evaluate the nature and effectiveness of nurse-led interventions on symptoms for people with cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8522592/

Development of A Nurse-Led Educational Intervention ... This article aimed to report the experience of developing a complex nurse-led, theory-driven, and evidence-based educational intervention program

4. scholarlycommons.baptisthealth.net scholarlycommons.baptisthealth.net/cgi/viewcontent.cgi?article=1189&context=nhsrj

A Nurse Navigator-Led Education Project to Increase ... The purpose of this evidence-based practice project was to implement an oncology nurse navigator (ONN)-led survivorship patient education ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Is nurse-led case management effective in improving treatment outcomes for cancer patients? A systematic review and meta-analysis. J Adv ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8493814/

A nurse-led intervention for fear of cancer progression in ... The study aims were to: (1) assess the feasibility and acceptability of a nurse-led intervention for managing FOP and distress in patients with advanced cancer; ...

7. researchgate.net researchgate.net/publication/49762905_Effects_of_Nurse_Navigators_on_Health_Outcomes_of_Cancer_Patients

Effects of Nurse Navigators on Health Outcomes of Cancer ... This study provides evidence that standardized nurse navigator programs can improve patient outcomes in cancer care. Positive outcomes of the ...