A Randomised Clinical Trial Testing the Effect of an Individualised and Patient-centred Follow-up Program for Women With Gynaecological Cancer

Background The 2015 release of a new "Follow-up Program for Gynecological Cancers" by the Danish Health Authority (DHA) marked a break with traditional follow-up. The conclusion, derived from a Health Technology Assessment report from 2009 assessing the value of follow up in patients with endometrial and ovarian cancer, was, that regular follow-up visits do not improve survival and may consume unnecessary resources from both patients and health care personnel. As a consequence, a need based program was proposed where the follow-up is planned individually and adjusted according to patient's needs, risks and resources. It was further emphasized that patient's self-care ability should be supported and that access to specialist assessment should be easy available.

The new follow-up program was soon implemented in most national gynecological centers without previous evaluation in a pilot setting and with sparse evidence of benefits and harms. Further, as the recommendations from the DHA were broad, various forms of the model were introduced. Optimally, a national common professional agreement to standardize this transformation should be made. However, there is neither consistency nor sufficient knowledge about the optimal organizational follow-up model for gynecological cancer patients for this to be accomplished.

Internationally, various follow-up models for patients with cancer have been tested over the past decade. In the gynecological setting, evidence of the most optimal organization of follow-up is sparse. In general, studies suggest that follow-up conducted in a nurse or general practitioner setting demonstrate similar survival and recurrence detection rates and similar or slightly better rates of satisfaction and quality of life as compared to follow-up in a conventional setting.

From previous national studies on survivorship in Danish cancer patients it was learned learned that involvement of the general practitioners (GPs) in the follow-up process was not superior, and one in ten cancer patient was not satisfied with the contribution from their GP during the follow-up. Further, studies have shown that socioeconomic status had a significant impact on participation in rehabilitation activities of gynecological cancer patients with cervical and ovarian cancer patients being especially vulnerable. Unmet needs after cancer was found to be significantly associated with lower quality of life emphasizing the importance of need assessment. Preliminary data from a local randomized trial of follow up vs. no follow up in low risk endometrial cancer patients indicate that women report a higher degree of fear of recurrence after cancer treatment if they receive no follow-up as compared to a group receiving conventional follow-up. Hence, results obtained from prior studies on survivorship following gynecological cancer treatment indicate that follow-up to some extent seems needed and emphasize a need to develop new programs that facilitates self-management but at the same time embrace those most vulnerable. Question is how the patients needs are best accommodated with limited resources available. Comprehensive evaluation of effects, benefits and harms are essential before implementation of new initiatives.

This randomized study suggests a strong focus on promotion of cancer patients' self-care ability, in this study conceptualized as empowerment. Empowerment has been described as "a process by which people, organizations, and communities gain mastery over their affairs" and empowerment processes as "processes in which attempts to gain control, obtain needed resources, and critically understand one's social environment are fundamental. The process is empowering if it helps people to develop skills so that they can become independent problem-solvers and decision-makers". Focus on improvement of patient empowerment may thus unify the need for patient involvement, promotion of self-care ability and re-allocate resources to those patients most vulnerable who are often neglected in the follow-up process. Further, by empowering patients to master the consequences of their cancer disease, they may have fewer unmet needs, which may altogether improve quality of life and reduce fear of recurrence.