OPEN Research Support
head

Physician
Anette Stolberg Kargo
Department of Oncology, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.06.2017  
Slut 31.12.2019  
 



Development of a Decision Aid to Facilitate Ovarian Cancer Patient's Choices Regarding Biomarker CA125

Short summary

The majorities of patients with ovarian cancer are diagnosed with advanced disease and will experience disease relapse with only limited curative potential. Early initiation of relapse treatment based on rising CA125 alone does not improve survival. Increasing CA125 can be detected months before symptoms arise and recurrence is visible on imaging. Therefore, biochemical detection of potential relapse by CA125 assessment can cause significant distress. A decision aid is a tool that provides information and describes advantages and disadvantages of a specific intervention thereby facilitating patient's involvement in decision making. 


Rationale

In Denmark, ovarian cancer (OC) is the fourth leading cause of cancer death, after lung, breast and colorectal cancers. Yearly, 500 new cases of OC are registered. Diagnosis of the disease at an early stage is associated with significantly improved survival rate. The majorities of patients are asymptomatic, or have had symptoms for a short time and 75-85% are diagnosed in an advanced stage.  There is to date no reliable method to screen for OC. For the vast majority of patients, surgery and chemotherapy is the corner stone in treatment of OC and the initial response rates are as high as 70-85%. Despite this initial high response rate, about 80% will have recurrence of the cancer within 2 years after the primary treatment, with small chance of cure. The treatment is therefore mainly palliative.

In 2011 a randomized trial were published with the aim to clarify the potential benefits of early treatment in asymptomatic women, who were treated with chemotherapy based on increased CA125 alone. Compared to women, who did not begin treatment until symptoms appeared, these women did not live longer The conclusion was, that early chemotherapy treatment initiated after biochemical detectable relapse, did not improve overall survival, but reduced quality of life compared to patients  treated when  symptoms of relapse appeared.

The Danish Health authorities have initiated major changes in the national Follow up program for cancer patients. The program is no longer meant to be standardized but to some degree based on an assessment of the individual patients' needs and preferences. Arguing that there is no effect of routine check of the patient using physical examination, imaging (CT scans etc.), and / or CA 125 monitoring in terms of apparent improved survival.

Shared decision making (SDM) is defined as an approach in which, the clinician and patient go through all phases of the decision-making process together and in which, they share the preference for treatment and reach an agreement on treatment choice. Clinicians have information about disease, tests and treatments, whereas patient holds information about their life circumstances, goals for life, and preferences for healthcare. SDM thereby offers a way of individualizing recommendations, according to patients' special needs and preferences. SDM has potential to give the patients a higher quality of healthcare, by putting the patient in the center of care. At present, SDM is not widely used in clinical practice. Especially with regard to cancer care, studies suggest, that oncologists often do not involve patients in the decision-making process to the extent that is desired by the patients. Clinicians often underestimate the strong wish, that patients have to be involved in the clinical decision-making process. This makes it essential to discuss with patients in explicit terms the role, they wish to have in that process.

Decision aids are tools that can provide information and systematically describes the advantages and disadvantages of a specific intervention or monitoring, which can help patients to become involved in decision making. Evidence show that using evidence-based DA for patients leads to improvements in knowledge, better understanding of screening, prevention and treatment options, and more accurate perception of risks.

The new follow up program highlights that each woman's personal preferences should be taken into account for systematic monitoring of CA 125 during follow up, which requires patient's knowledge about the pros and cons. For this purpose the development of a national decision-aid, which systematically describes the advantages and disadvantages of CA125 monitoring in collaboration between patient organizations and medical societies has been suggested to be developed and integrated in the national Follow up program.

All participants fill in a demographic and Decisional Conflict Scale questionnaire at baseline. After having been presented with the decision aid and made a choice as to CA125, the participants will complete the CollaboRATE and Decisional Conflict Scale questionnaire dealing with confidence as to the choice made and the level of shared decision making experienced. Six months later the Decision Regret Scale questionnaire is to be completed to reveal any regrets in relation to the CA125 decision.

The study aims are: To develop and validate a decision aid targeting the systematic use of CA125 monitoring during follow-up.


Description of the cohort

Women diagnosed with ovarian cancer who have completed first line treatment are recruited to the study at their 3 months follow-up. Participants are recruited from Department of Oncology at Vejle Hospital.   


Data and biological material

Clinical data - regarding identification, cancer type, FIGO stage, type of treatment, CA125 level at diagnosis and at treatment end.

Demographic questionnaire - educational level, social status, children

Decisional Conflict Scale - measures personal perceptions of: uncertainty in choosing options. Are presented for patients before and after they have seen the Decision Aid.

CollaboRATE - measures involvement in decision making.

Decisional Regret Scale - measures regret after making health care decisions.


Collaborating researchers and departments

Department of Oncology, Vejle Hospital

  • Associate Professor Karina Dahl Steffensen. MD, PhD, Director of Center for Shared Decision Making
  • Professor Angela Coulter

Department of Gynaecology and Obstretrics,Odense University Hospital

  • Pernille T. Jensen, MD, PhD