Clinical trial NCT01691144: Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project
Official title: Gynecological Cancer Survivors' Views on Follow-up After Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Ovarian Cancer
Cervical Cancer
Keywords: cancer
gynecological
expectations
satisfaction
cooperation
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 239
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly treated gynecological cancer patients and patients treated 2-3 years ago

Brief summary: Follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. In some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. In this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. Further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. In addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. The investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.

Detailed description: After gynaecological cancer patients have completed their treatment, they are followed up at a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to detect recurrence, improve survival and reduce adverse effects of the treatment. The national guide for oncological gynaecology recommends follow-up by a specialist for five years at intervals depending on cancer type. Several review studies on follow-up of endometrial, cervical and ovarian cancer patients show large international variations in follow-up routines. There are only retrospective studies available, and they indicate that most recurrences are discovered within the first three years after completed treatment, and, in most cases, by the women themselves. More intensive surveillance does not appear to affect the time for discovery of recurrence.

A few randomised controlled studies and retrospective cohort studies have been published that focus on follow-up of colon cancer and breast cancer patients by general practitioners versus by hospital specialists. These studies have not shown any significant differences between the groups in terms of detection of recurrence, incidence of serious clinical events connected with recurrence or health-related quality of life.

The investigators therefore plan to perform a study in which both gynaecological cancer patients and their regular general practitioners are asked about their views on patient follow-up after completed treatment. The investigators especially wish to focus on the collaboration aspect.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* histologically or cytologically proven cancer

Exclusion Criteria:

* Unability to fill out questionnaires (due to language or cognitive barriers)

Primary outcomes:
measure: Patient expectation questionnaire
timeFrame: within the first 30 days after primary treatment
Secondary outcomes:
measure: Patient satisfaction questionnaire
timeFrame: 3 years after treatment
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital Kristiansand
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: University of Oslo
name: Mette Brekke, PhD
role: STUDY_CHAIR
References:
citation: Vistad I, Moy BW, Salvesen HB, Liavaag AH. Follow-up routines in gynecological cancer - time for a change? Acta Obstet Gynecol Scand. 2011 Jul;90(7):707-18. doi: 10.1111/j.1600-0412.2011.01123.x. Epub 2011 Apr 15.
citation: Vistad I, Cvancarova M, Salvesen HB. Follow-up of gynecological cancer patients after treatment - the views of European experts in gynecologic oncology. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1286-92. doi: 10.1111/j.1600-0412.2012.01523.x. Epub 2012 Sep 18.