Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project

Completed

• Conditions: Endometrial Cancer; Ovarian Cancer; Cervical Cancer

• Registration Number: NCT01691144
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study First Submitted: 2012-08-15
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 239

Inclusion Criteria

• > 18 years
• histologically or cytologically proven cancer

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient expectation questionnaire	within the first 30 days after primary treatment	The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction questionnaire	3 years after treatment	The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years

Trial Locations

Locations (2)

St. Olavs Hospital; 🇳🇴 Trondheim, Norway

Sorlandet Hospital Kristiansand; 🇳🇴 Kristiansand, Norway