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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the HOPE intervention, a behavioral therapy, can reduce feelings of hopelessness and helplessness in women with recurrent ovarian cancer. Recurrent ovarian cancer often causes severe stress and diminishes quality of life, making it essential to find ways to enhance mental well-being. Participants will either join the HOPE workshops or continue with their usual care to compare outcomes. Women with recurrent ovarian cancer who speak English and can provide informed consent may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research focused on improving mental well-being for these women.

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 prior data suggests that the HOPE intervention is safe for patients with recurrent ovarian cancer?

Research has shown that the HOPE program helps ovarian cancer patients manage feelings of hopelessness and helplessness. This program targets patients with recurrent ovarian cancer, which often leads to significant emotional distress.

The HOPE program focuses on improving emotional well-being without physical side effects. Previous studies have indicated that such programs are generally well-tolerated. Participants often report feeling less depressed and anxious. There are no known physical risks, as the HOPE program involves workshops and discussions, not medication or medical procedures.

In summary, the HOPE program is considered safe and aims to positively impact the emotional health of those facing recurrent ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HOPE Intervention is unique because it focuses on a behavioral approach rather than traditional medical treatments like chemotherapy or surgery, which are common for recurrent ovarian cancer. This intervention offers a series of engaging workshops, which can be attended virtually or in person, making it more accessible and less invasive. Researchers are excited about this trial because it explores how psychological and behavioral support can improve the quality of life for patients, potentially complementing existing medical treatments and addressing mental and emotional well-being.

What evidence suggests that the HOPE intervention is effective for reducing hopelessness and helplessness in recurrent ovarian cancer patients?

Research has shown that the HOPE program, which participants in this trial may receive, might help reduce feelings of hopelessness and helplessness in patients with recurring ovarian cancer. A study on a similar program found that patients noticed improvements in their mental health and overall outlook. Another study highlighted that ovarian cancer patients often face major life changes and emotional challenges, emphasizing the need for support like HOPE. Past patients demonstrated that programs focusing on coping strategies can enhance quality of life and mental health. By joining programs like HOPE, patients may discover better ways to handle the emotional difficulties of recurring ovarian cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Megan J Shen, PhD.

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6556148/

The HOPE Pilot Study: Harnessing Patient-Reported ... The objective of the current study was to assess the feasibility, acceptability, and perceived effectiveness of a mobile health intervention that was designed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02090582

H.O.P.E: Helping Ovarian Cancer Patients Cope The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3825308/

The Gynecologic Cancer Intergroup Symptom Benefit Study In a prospective study of 27 women with recurrent ovarian cancer offered second- or third-line chemotherapy, only 7 had objective evidence of symptom ...

4. tandfonline.com tandfonline.com/doi/full/10.2217/fon-2023-0450

The Power of Hope: Views of Ovarian Cancer Patients on ... This study indicated considerable life changes for a number of the 152 patients surveyed, with 14% of patients' living situations having changed, 30% of ...

5. researchgate.net researchgate.net/publication/373913888_The_power_of_hope_Views_of_Ovarian_Cancer_patients_on_how_maintenance_therapy_Affects_their_Lives_VOCAL

The Power of Hope: Views of Ovarian Cancer Patients ... Results: Among 1920 patients, 22.2% received MT and 77.8% received AS. Median IPC-weighted TTNT and OS were 13.3 months (95% CI 11.7-15.8) and ...

6. fredhutch.org fredhutch.org/en/news/center-news/2025/04/awards-against-ovarian-cancer-for-fred-hutch-uw-researchers.html

$600000 in awards against ovarian cancer for Fred Hutch ... In response came HOPE, an intervention to reduce hopelessness and helplessness in patients with recurrent ovarian cancer. The program brings ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08640

Helping Ovarian Cancer Patients Cope with Their Illness ... 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 ...