ENdometrial cancer SURvivors' follow-up carE (ENSURE): Less is more? Randomized controlled trial to evaluate patient satisfaction and cost-effectiveness of a reduced follow-up schedule

The optimal follow-up schedule for patients with endometrial cancer is
unknown. As a result, guidelines in the Netherlands are consensus-based and do
not take risk profile into account. Due to current emphasis on providing good
care for lower costs, a critical evaluation of current follow-up practices for
cancer patients is needed. Endometrial cancer is the most common gynaecological
cancer, with 2000 newly diagnosed patients per year in the Netherlands. Today,
about 20,000 women living in the Netherlands have survived endometrial cancer.
Of them, 7,000 were diagnosed in the past 5 years and are currently receiving
follow-up care. Most patients receive 5 year follow-up, with visits each 3 or 4
months in the first 2 years after treatment, each 4 to 6 months in the 3rd year
and annually in the 4th and 5th year. Reasons for follow-up include early
diagnosis of recurrences -for which curative treatment is available-,
signalling consequences of cancer and treatment, psychosocial support, and
information provision.

There are multiple reasons to decrease follow-up frequency. First, there is no
survival benefit in the detection of asymptomatic recurrences at routine
follow-up, compared with symptomatic recurrence or interval detection, probably
because the recurrence rate of early-stage endometrial cancer survivors is low
(3%) and because most recurrences (70%) present with symptoms. The majority
(70-100%) of the recurrences occur within 3 years. Second, consequences of
cancer and treatment are found in only 6% of the stage 1 patients who received
surgery (hysterectomy and salpingo-oophorectomy) alone. Third, follow-up visits
evoke distress around the time of the visits. Finally, alternative follow-up
schedules in other cancer populations do not show decreased patient
satisfaction or Health-Related Quality of Life (HRQoL). Reasons to retain
follow-up are that follow-up is beneficial for patients for reassurance, to
provide support for psychosocial, physical and sexual problems, and to provide
information.

These findings strongly suggest that most early-stage endometrial cancer
patients do not need intensive follow-up to detect recurrences, improve
survival or discuss consequences of treatment, but patients may need some
follow up to detect information needs and provide psychosocial counselling.
Therefore, the current follow-up schedule for low-risk early-stage endometrial
cancer patients -about 55% of all patients with endometrial cancer- should be
reduced to eliminate unnecessary care, decrease patient worry around visits,
prevent wrong patient expectations and save health care costs.

Additionally, it is increasingly recognized that cancer survivors should be
provided with tailored information about their disease, treatment, care
providers, physical and psychosocial consequences of their cancer and its
treatment, care services and health promotion information. The Institute of
Medicine advices the use of Survivorship Care Plans (SCPs) to provide cancer
survivors this information. However, large scale implementation of SCPs is
currently lacking

To obtain evidence on the effects of a reduced follow-up schedule we propose to
conduct a nationwide randomized controlled trial (RCT) to study the effects of
a reduced follow-up schedule for patients with endometrial cancer. The research
question was encountered in the clinical practice of gynaecologic oncology as
an urgent need to critically evaluate the possibilities to implement a reduced
follow-up practice for endometrial-cancer survivors. If the reduced follow-up
schedule results in a similar patient satisfaction at lower costs, the current
guideline will be adapted and the reduced schedule can be implemented
throughout the Netherlands

The aim of this study is to compare a reduced follow-up schedule of 4 visits
among low-risk, early-stage endometrial cancer survivors, with the schedule
according to the current Dutch guideline that includes 10 to 13 visits, on:
Primary outcomes:
1. Patient satisfaction with follow-up care (at 6, 12, 36 and 60 months after
completion of primary treatment)
2. Costs-effectiveness from the health care perspective (after 3 and 5 years.)

Secondary outcomes:
• Health care use -gynaecologist, (specialist) nurse, primary care physician
and other health or care services-; adherence to the indicated follow-up
protocols; reasons for non-adherence
• HRQoL, worry including fear of recurrence, anxiety and depression, and
satisfaction with information provision
• Health care providers* satisfaction with follow-up schedule (gynaecologist,
(specialised) nurse)
• Time till recurrence and survival

Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients
(n=282) are randomized in an intervention group with 4 follow-up visits during
3 years, and a control group with 10-13 follow-up visits during 5 years,
according to the Dutch guideline. Patients are asked to fill out a
questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take
two years (if 60% of the patients participate).

4 follow-up visits, after 3, 12, 24 and 36 months (intervention) vs. regular
follow-up according to the guideline, 10-13 visits during 5 years (control)

In both arms, patients fill out 5 questionaires, 1 after treatment, after 6
months and after 1, 3 and 5 year. The intervention group has to go less often
to the hospital (4 times) in comparison with the control group (10-13 times)