Behavioral Intervention for Recurrent Ovarian Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fred Hutchinson Cancer Center
Disqualifiers: Non-invasive gynecologic disease
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
35678How 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.
39101112Eligibility 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
I am 18 years old or older.
English speaking
Able to provide informed consent
+1 more
Exclusion Criteria
I have a non-invasive gynecologic condition.
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Aim 2, Group I (HOPE intervention workshop)Experimental Treatment3 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 Treatment4 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 Control2 Interventions
Patients receive usual care on study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutch/University of Washington Cancer ConsortiumSeattle, WA
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Who Is Running the Clinical Trial?
Fred Hutchinson Cancer CenterLead Sponsor
References
Quality of life in ovarian cancer. [2005]While there has not been a dramatic improvement in the cure rate of ovarian cancer, >40% of women survive longer than 5 years, with what is commonly considered a "chronic" cancer. In each phase of the illness (diagnosis, surgery and chemotherapy with curative intent, remission and survivorship, relapse and sequential chemotherapy, bowel obstruction and end of life), quality of life (QOL) is one of the most important considerations. There has recently been a large increase in studies reporting the assessment of QOL; that has changed the field from descriptive reporting to quantitative science. There are well-validated, standardized scales, and approximately 10% of randomized cancer trials include health-related QOL as one of the main end points. This article reviews the history and development of QOL evaluation and the 2 main approaches to QOL assessment (psychometric based and utility based) and describes strategies for meaningful interpretation of QOL profiles. While the humanities perhaps teach us much about the value of QOL, the science of the study of QOL will be the foundation and confirmation of many of the anticipated advances for patients.
Enhancing hope in people with a first recurrence of cancer. [2022]Enhancing hope in people with a first recurrence of cancer Researchers and clinicians have identified the need for well-defined intervention studies to test the efficacy of interventions designed to strengthen hope. This quasi-experimental study sought to determine if a specific nursing intervention program designed to enhance hope would positively influence levels of hope and quality-of-life (QOL) in a convenience sample of 115 people with a first recurrence of cancer who were randomly assigned to one of three groups: treatment group (hope), attention control group (informational), or control group (usual treatment). The Herth Hope Index (HHI) and the Cancer Rehabilitation and Evaluation Systems, Short Form (CARES-SF) were administered prior to intervention, immediately after intervention and at 3, 6, and 9-month intervals. Treatment and control groups differed significantly with regard to level of hope (P=0.02) and QOL (P=0.03). Both the level of hope and QOL were significantly increased (P=0.03) immediately after intervention and across time (3, 6 and 9 months). This study was a preliminary attempt to design, implement, and evaluate a theory-driven hope intervention program. Knowledge about the effectiveness of specific interventions designed to enhance hope is vital if nurses are to significantly influence hope in those whom are in their care.
Coping strategies, trajectories, and their associations with patient-reported outcomes among women with ovarian cancer. [2018]Most women with ovarian cancer present with advanced stage disease and face aggressive treatments, recurrence, and possible death, yet little is known about how they cope. Our objective was to identify coping strategies used by women with ovarian cancer and their trajectories of use after diagnosis and to assess if coping trajectories are associated with subsequent anxiety, depression, or quality of life.
Transforming the death sentence: elements of hope in women with advanced ovarian cancer. [2022]To describe the experience of hope in women with advanced ovarian cancer.
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]Patient-reported outcomes (PROs) provide a valid, standardized way of assessing symptoms, adverse events and the subjective benefit of treatment from the patient's perspective. Assessment of PROs is critical in ovarian cancer due to the high morbidity of the disease and its treatments. Several well-validated PRO measures are available to assess PROs in ovarian cancer. Their inclusion in clinical trials can provide evidence on the benefits and harms of new treatments based on patients' experiences to guide improvements in clinical practice and health policy. Aggregate PRO data collected in clinical trials can be used to inform patients about likely treatment impacts and assist them to make informed treatment decisions. In clinical practice, PRO assessments can facilitate monitoring of a patient's symptoms throughout treatment and follow-up to guide their clinical management; in this context, an individual patient's responses can facilitate communication with their treating clinician about troublesome symptoms and their impact on their quality of life. This literature review aimed to provide clinicians and researchers with a better understanding of why and how PROs can be incorporated into ovarian cancer clinical trials and routine clinical practice. We discuss the importance of assessing PROs throughout the ovarian cancer disease and treatment trajectory in both clinical trials and clinical practice, and provide examples from existing literature to illustrate the uses of PROs as the goals of treatment change in each setting.
Prevention and treatment of adverse effects related to chemotherapy for recurrent ovarian cancer. [2019]To review the side effects frequently observed with ovarian cancer, focusing on the development of interventions to assess, prevent, and treat these events.
Ovarian cancer study dropouts had worse health-related quality of life and psychosocial symptoms at baseline and over time. [2022]Participant drop out is a major barrier to high-quality patient-reported outcome (PRO) data analysis in cancer research as patients with worsening health are more likely to dropout. To test the hypothesis that ovarian cancer patients with worse PROs would drop out earlier, we examined how patients differed by time of dropout on health-related quality of life (HRQOL), anxiety, depression, optimism and insomnia.
Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. [2023]Poly(ADP-ribose) polymerase inhibitors (PARPi) have dramatically changed treatment for advanced ovarian cancer, but nearly half of patients experience significant fatigue. We conducted a two-site pilot randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a brief, acceptance-based telehealth intervention (REVITALIZE) designed to reduce fatigue interference in patients on PARPi.
Pros and cons for systemic therapy in recurrent ovarian cancer. [2009]Due to the high recurrence rates of ovarian carcinoma, the treatment of recurrent disease is currently one of the most challenging topics in the clinical setting. Ovarian cancer patients who do not respond to initial chemotherapy or who relapse after achieving a response are generally incurable. Treatment goals after failure of first-line treatment for ovarian cancer include: (a) controlling or preventing disease-related symptoms, (b) maintaining quality of life by choosing an effective treatment with low toxicity potential, and (c) prolonging progression-free survival. In contrast to the adjuvant situation in which prospective randomized phase III trials have established the current standard, only a few randomized trials are available for patients with recurrent disease. In addition, a series of agents has been shown to have clinical activity in recurrent ovarian cancer, including topotecan, pegylated liposomal doxorubicin, gemcitabine and oral etoposide. It has also been demonstrated that re-treatment with a platinum drug and taxane has been associated with a significant clinical activity in patients with "sensitive" (treatment-free interval >6 months) recurrent disease. The role of antihormonal therapy is still unclear. These possible treatments for recurrent ovarian cancer require prospective randomized trials comparing efficacy, toxicity and quality of life.
Coping Strategies among Malaysian Women with Recurrent Ovarian Cancer: A Qualitative Study. [2022]Ovarian cancer is one of the most common cancers among Malaysian women with high recurrence. Patients with recurrence are prone to emotional distress and are forced to cope with poor prognosis. This study aimed to explore the coping strategies employed by women with recurrent ovarian cancer in Malaysia, a developing multicultural country in Asia.
Psychosocial management of patients with recurrent ovarian cancer: treating the whole patient to improve quality of life. [2019]To describe the psychosocial issues affecting women with recurrent ovarian cancer and provide suggestions for screening to provide appropriate referrals.
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]Ovarian cancer is the most common cause of gynecological cancer death in United States women. Efforts to improve progression free survival (PFS) and quality of life (QoL) after treatment for ovarian cancer are necessary. Observational studies suggest that lifestyle behaviors, including diet and physical activity, are associated with lower mortality in this population. The Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES) NRG 0225 study is a randomized, controlled trial designed to test the hypothesis that a 24month lifestyle intervention will significantly increase PFS after oncological therapy for stage II-IV ovarian cancer. Women are randomized 1:1 to a high vegetable and fiber, low-fat diet with daily physical activity goals or an attention control group. Secondary outcomes to be evaluated include QoL and gastrointestinal health. Moreover an a priori lifestyle adherence score will be used to evaluate relationships between adoption of the diet and activity goals and PFS. Blood specimens are collected at baseline, 6, 12 and 24months for analysis of dietary adherence (carotenoids) in addition to mechanistic biomarkers (lipids, insulin, telomere length). Women are enrolled at NRG clinic sites nationally and the telephone based lifestyle intervention is delivered from The University of Arizona call center by trained health coaches. A study specific multi-modal telephone, email, and SMS behavior change software platform is utilized for information delivery, coaching and data capture. When completed, LIVES will be the largest behavior-based lifestyle intervention trial conducted among ovarian cancer survivors.