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

Ovarian Cancer Clinical Trial

Official title:

Gynecological Cancer Survivors` Views on Follow-up After Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691144
• Other study ID #: 2012/355B
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: May 11, 2016
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• histologically or cytologically proven cancer

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Ovarian Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Norway	Sorlandet Hospital Kristiansand	Kristiansand
Norway	St. Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient expectation questionnaire	The patients will be asked to fill in a quesionnaire regarding their expectations on follow-up care	within the first 30 days after primary treatment	No
Secondary	Patient satisfaction questionnaire	The patients will be asked to fill in a quesionnaire regarding their satisfaction on follow-up care after three years	3 years after treatment	No