Behavioral Intervention for Recurrent Ovarian Cancer

Overseen By Megan J. Shen, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Non-invasive gynecologic disease

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

Compensation: Varies

Number of Visits: 8

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

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 data supports the effectiveness of the HOPE Intervention treatment for recurrent ovarian cancer?

Research shows that a nursing program designed to boost hope can significantly improve hope levels and quality of life in people with a first recurrence of cancer. This suggests that the HOPE Intervention might help improve the well-being of patients with recurrent ovarian cancer by enhancing their sense of hope. ^{1 2 3 4 5}

Is the HOPE Intervention safe for humans?

The available research does not provide specific safety data for the HOPE Intervention or similar behavioral interventions for recurrent ovarian cancer. However, patient-reported outcomes (PROs) are used in clinical trials to assess the benefits and harms of treatments based on patients' experiences, which can help inform safety considerations. ^{3 5 6 7 8}

How does the HOPE Intervention treatment differ from other treatments for recurrent ovarian cancer?

The HOPE Intervention is unique because it focuses on behavioral strategies to help women cope with the emotional and psychological challenges of recurrent ovarian cancer, unlike traditional treatments that primarily target the physical aspects of the disease. ^{3 9 10 11 12}

What is the purpose of this trial?

This clinical trial compares the effect of the Helping Ovarian Cancer Patients Cope with Their Disease (HOPE) intervention to usual care for the reduction of hopelessness and helplessness in patients with ovarian cancer that has come back after a period of improvement (recurrent). Patients with recurrent ovarian cancer are at high risk for increased death and poor mental health outcomes, including depression and anxiety. Ovarian cancer is the deadliest of all gynecologic cancers, with a survival rate at five years of only 50%. Most patients are diagnosed with advanced disease and have a high chance of recurrent disease that is incurable, even if upfront treatments are effective. Ovarian cancer's advanced diagnosis, high likelihood of recurrence and death, and rigorous treatment including surgery and other cancer therapies create high levels of distress and reduced quality of life (QOL). Patients with recurrent ovarian cancer report high rates of depression and anxiety and poor QOL. Due to the major distress, reduced QOL, and likelihood of death among this population, improving this patient population's QOL is a priority. Using the HOPE intervention may be effective in reducing hopelessness and helplessness in recurrent ovarian cancer patients.

Research Team

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

The HOPE trial is for patients with recurrent ovarian cancer who are experiencing high levels of distress and reduced quality of life. It aims to help them cope better with their illness.

Inclusion Criteria

English speaking

Able to provide informed consent

I have recurrent ovarian cancer.

Exclusion Criteria

I have a non-invasive gynecologic condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HOPE Intervention Workshop

Participants complete the HOPE intervention workshop virtually or in-person, consisting of 3 sessions held once per week, each lasting 60 to 90 minutes.

3 weeks

3 visits (virtual or in-person)

Follow-up

Participants complete follow-up assessments to evaluate the effectiveness of the intervention.

12 weeks

Assessments at 5, 8, and 12 weeks post-randomization

Treatment Details

Interventions

• HOPE Intervention

Trial Overview This study tests the 'Helping Ovarian Cancer Patients Cope' (HOPE) intervention against usual care, focusing on reducing feelings of hopelessness and helplessness in these patients.

Participant Groups

Group I: Aim 2, Group I (HOPE intervention workshop) Experimental Treatment 3 Interventions

Patients complete the HOPE intervention workshop either virtually or in person, with three weekly sessions, each lasting 60 to 90 minutes.

Group II: Aim 1 (HOPE intervention workshop, survey, interview) Experimental Treatment 4 Interventions

Patients complete the HOPE intervention workshop virtually or in person. The workshop consists of three weekly sessions, each lasting 60 to 90 minutes, along with a survey and an interview for HOPE Intervention refinement during follow up.

Group III: Aim 2, Group II (usual care) Active Control 2 Interventions

Patients receive usual care on study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Findings from Research

Over 40% of women with ovarian cancer survive longer than 5 years, indicating that it can be managed as a chronic illness, but quality of life (QOL) remains a critical focus throughout all phases of treatment.

Recent advancements in QOL assessment have shifted the field towards quantitative science, with about 10% of randomized cancer trials now including health-related QOL as a key endpoint, highlighting its importance in evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in ovarian cancer. Penson, R., Cella, D., Wenzel, L.[2005]

A nursing intervention program aimed at enhancing hope significantly improved levels of hope and quality of life in 115 cancer patients with a first recurrence, as measured by the Herth Hope Index and CARES-SF.

The positive effects on hope and quality of life were observed immediately after the intervention and continued to be significant at 3, 6, and 9 months, highlighting the long-term benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing hope in people with a first recurrence of cancer. Herth, K.[2022]

A study involving 634 women with ovarian cancer identified three main coping strategy clusters, with distinct patterns of use over time, highlighting the importance of coping mechanisms in managing their condition.

Women who accepted their diagnosis reported significantly lower levels of anxiety and depression, as well as better quality of life, suggesting that promoting acceptance and positive coping strategies could enhance mental health outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping strategies, trajectories, and their associations with patient-reported outcomes among women with ovarian cancer. Beesley, VL., Smith, DD., Nagle, CM., et al.[2018]

The study involved 20 women aged 42-73 with advanced ovarian cancer, revealing that their experience of hope is crucial for coping with the distress of their diagnosis, which they often perceive as a 'death sentence.'

Women who felt higher levels of support and perceived control were more hopeful and better able to transform their fear of death into a meaningful experience, highlighting the importance of effective communication and spiritual support in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforming the death sentence: elements of hope in women with advanced ovarian cancer. Reb, AM.[2022]

Patient-reported outcomes (PROs) are essential in ovarian cancer research and treatment, as they provide standardized assessments of symptoms and treatment benefits from the patient's perspective, helping to guide clinical practice and health policy.

Incorporating PROs into clinical trials and routine practice allows for better monitoring of patient symptoms and quality of life, enabling informed treatment decisions and improved communication between patients and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in Ovarian Cancer: Facilitating and Enhancing the Reporting of Symptoms, Adverse Events, and Subjective Benefit of Treatment in Clinical Trials and Clinical Practice. Campbell, R., King, MT., Stockler, MR., et al.[2023]

Treatment-related side effects significantly affect the quality of life for patients with recurrent ovarian cancer, highlighting the need for effective assessment and management strategies.

Oncology nurses play a crucial role in monitoring these side effects and can implement proactive interventions based on their knowledge of side effects and their relationship to treatment doses and schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and treatment of adverse effects related to chemotherapy for recurrent ovarian cancer. Edwards, SJ.[2019]

In a study of 619 ovarian cancer patients, those who dropped out earlier had significantly worse health-related quality of life (HRQOL) and higher levels of depression at the start, indicating that poorer initial mental and physical health is linked to higher dropout rates.

The research found that as time progressed, dropouts experienced a faster decline in HRQOL, anxiety, and optimism compared to those who completed the study, emphasizing the need for careful data handling in patient-reported outcomes to account for these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer study dropouts had worse health-related quality of life and psychosocial symptoms at baseline and over time. Mercieca-Bebber, RL., Price, MA., Bell, ML., et al.[2022]

The REVITALIZE telehealth intervention was found to be feasible and acceptable for patients with advanced ovarian cancer on PARP inhibitors, with a high completion rate of 86.3% for the 12-week follow-up assessment.

Participants in the REVITALIZE group experienced significant reductions in fatigue interference and severity, as well as improved overall fatigue levels, compared to those receiving enhanced usual care, suggesting that this intervention could help manage treatment-related fatigue effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. Wright, AA., Poort, H., Tavormina, A., et al.[2023]

Recurrent ovarian carcinoma presents significant treatment challenges, as patients who do not respond to initial chemotherapy or relapse are generally considered incurable, highlighting the need for effective management strategies.

Several agents, including topotecan and pegylated liposomal doxorubicin, show clinical activity in recurrent ovarian cancer, particularly in patients with 'sensitive' disease, but more randomized trials are needed to compare their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pros and cons for systemic therapy in recurrent ovarian cancer. Oskay-Ozcelik, G., Sehouli, J.[2009]

A qualitative study involving 10 women aged 52-84 with recurrent ovarian cancer identified six main coping strategies, including maintaining hope, avoiding information, and seeking spiritual help.

The coping strategies were largely influenced by personal beliefs and emotions rather than accurate information about their condition, highlighting the need for better support and education for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping Strategies among Malaysian Women with Recurrent Ovarian Cancer: A Qualitative Study. Lee, YK., Praveena, KA., Woo, YL., et al.[2022]

Women with recurrent ovarian cancer face significant psychosocial issues that require tailored support, including practical, informational, and emotional assistance.

Screening for psychosocial distress is crucial and can be done quickly, enabling nurses to identify patients who need further interventions, thereby improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial management of patients with recurrent ovarian cancer: treating the whole patient to improve quality of life. Fitch, MI.[2019]

The LIVES NRG 0225 study is a large randomized controlled trial involving women with stage II-IV ovarian cancer, aiming to determine if a 24-month lifestyle intervention focused on a high vegetable and fiber, low-fat diet and increased physical activity can improve progression-free survival (PFS) after treatment.

This study will also assess quality of life (QoL) and gastrointestinal health, using a comprehensive approach that includes dietary adherence monitoring and mechanistic biomarker analysis, making it the largest behavior-based lifestyle intervention trial for ovarian cancer survivors to date.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Thomson, CA., Crane, TE., Miller, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quality of life in ovarian cancer. [2005]

2. England pubmed.ncbi.nlm.nih.gov

Enhancing hope in people with a first recurrence of cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Coping strategies, trajectories, and their associations with patient-reported outcomes among women with ovarian cancer. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Transforming the death sentence: elements of hope in women with advanced ovarian cancer. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes in Ovarian Cancer: Facilitating and Enhancing the Reporting of Symptoms, Adverse Events, and Subjective Benefit of Treatment in Clinical Trials and Clinical Practice. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Prevention and treatment of adverse effects related to chemotherapy for recurrent ovarian cancer. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Ovarian cancer study dropouts had worse health-related quality of life and psychosocial symptoms at baseline and over time. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. [2023]

9. Greece pubmed.ncbi.nlm.nih.gov

Pros and cons for systemic therapy in recurrent ovarian cancer. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Coping Strategies among Malaysian Women with Recurrent Ovarian Cancer: A Qualitative Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Psychosocial management of patients with recurrent ovarian cancer: treating the whole patient to improve quality of life. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. [2023]