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

NCT ID: NCT01691144

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 239 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Endometrial Cancer; Ovarian Cancer; Cervical Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

recently treated patients

No interventions assigned to this group

2-3 years after treatment

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• > 18 years
• histologically or cytologically proven cancer

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Heidi Lidal Fidjeland

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mette Brekke, PhD

Role: STUDY_CHAIR

University of Oslo

Locations

Sorlandet Hospital Kristiansand

Kristiansand, , Norway

St. Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 21382018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22880840 (View on PubMed)

Other Identifiers

2012/355B

Identifier Type: -

Identifier Source: org_study_id