Improving Quality of Care for Patients With Recurrent Ovarian Cancer

NCT02809339 | Unknown

• 1 other identifier: MOGYN24
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ovarian cancer is a major cause of cancer related death among women. The disease is usually advanced at diagnosis, because specialist referral is delayed due to vague nature of presenting symptoms. Primary treatment is successful, but most patients experience recurrence. Complaints due to disease and therapy overlap. Furthermore treatment schedules are similar in response rate and survival rates. Toxicity of therapy as scored by the physician is best documented, but varies depending on type of chemotherapy. Moreover most knowledge is acquired in clinical trials and not in daily practice. Patient reported outcome (PROs) concerning effects on symptoms, velocity of relief and quality of life (QoL) by the different regimens is sparce. Also it is unknown which symptoms are best relieved. Most trials take into account progression or survival as primary endpoint but not often symptom relief, which is especially important for patients with recurrent disease, without no chance of cure anymore. Knowledge on rating of problems and needs of patients with recurrent ovarian cancer (ROC) to support them in the course of their disease is needed to come to an evidence based and patient centered treatment of choice together with the patient. Physicians most frequently use the Common Toxicity Criteria (CTC) scale for grading of side effects of treatment, but discrepancies with patient experiences is high. Routine collection of PROs may therefore improve patient expectations and management. In this project the investigators intend to augment knowledge by PROs of different chemotherapy schedules for recurrent ovarian cancer in order to improve shared decision making with the physician. Objective: primary objective of this project is to explore the relief of symptoms due to ROC, the speed with which this occurs by different chemotherapy schedules and development of complaints due to the regimen of chemotherapy. Secondary the investigators intend (1) to assess preferential symptom relief by patients, (2) to correlate toxicity and symptoms of disease to tumor assessed response to chemotherapy and (3) to correlate symptom relief by psychosocial context.

Conditions

Ovarian Neoplasms; Quality of Life

Keywords

Chemotherapy; ovarian cancer; Patient reported outcome; Quality of Care

Outcome Measures

Primary Outcomes (1)

• Velocity of disease symptom relief and its duration by systemic therapy measured by change in MOST questionnaires on PROs and response to therapy

  Change in MOST questionnaires as measured before start of therapy, at week 3, 6, 9 and 18 and and there after every 3 months until progression or 1 year

Secondary Outcomes (6)

• Change in patient reported disease symptoms top 3 due to systemic therapy on their top 3 of complaints

  change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year

• Change in top 3 complaints due to chemotherapy

  change measured by questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year

• Change in patient reported psychosocial wellbeing

  Change measured by HADS questionnaires before start of therapy, at week 9 and 18 and at time of progression or 1 year

• Change in patient reported empowerment

  Change measured by NEV questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year

• Change in patient reported needs

  Change measured on CASUN questionnaire before start of therapy, at week 9 and 18 and at time of progression or 1 year

Study Arms (1)

Epithelial ovarian cancer

Other: Questionnaires

Interventions

Questionnaires OTHER

Epithelial ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with recurrent epithelial ovarian cancer (EOC), tubal carcinoma or peritoneal carcinoma with measurable disease by radiology or tumor-marker and in adequate physical condition (ECOG≤2) to receive chemotherapy.

You may qualify if:

• Patients with recurrent EOC or tubal carcinoma or peritoneal carcinoma;
• Histologically and/or cytologically proven epithelial ovarian cancer (including carcinosarcoma of the ovaries)
• Measurable or evaluable disease confirmed by radiological imaging OR ca 125
• ECOG ≤2
• Estimated life expectancy ≥12 weeks
• Patients must be accessible for treatment and follow-up
• Fit to receive chemotherapy

You may not qualify if:

• Patients with benign ovarian cancer;
• Patients with non-epithelial cancer;
• Bowel obstruction, sub-occlusive disease or presence of symptomatic brain metastases;
• Patients with other malignancy occurring within 5 years before enrollment
• Patients with impaired cognitive functioning or analphabetic patients
• Patients with an inability to fill in surveys digitally

Sponsors & Collaborators

• Radboud University Medical Center: lead
• PharmaMar: collaborator

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nelleke Ottevanger, M.D. PhD

  Internist - Oncologist and Principal investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Rietveld, M.D. Msc.

CONTACT

+31 24 36 10353; mark.rietveld@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 22, 2016

Record last verified: 2016-04