NCT02404883

Brief Summary

Women who are diagnosed with cancer during their reproductive lifespan might be confronted with impaired fertility. Nowadays a number of fertility preservation options are available. Decisions about whether and how to protect fertility have to be made in a very short time period, right after cancer diagnosis and before start of treatment. The psychological impact for patients is considerable. This project aims at developing a standardized decision-aid tool to support the decision-making process about fertility preservation in young cancer patients. It is designed as an online decision-aid tool. A web-based tool is perfectly designed for this target group and offers new possibilities providing flexible and individually tailored information. The aim of the study is to examine the benefits of the online decision-aid tool compared with standard counseling (usual care). Decisional conflict is measured immediately after counseling as well as one month later. One year after counseling, decisional regret is being evaluated additionally. If the decision-aid tool proves to be helpful and useful, the online design allows making it available for a wide range of concerned patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

4.2 years

First QC Date

March 19, 2015

Last Update Submit

January 8, 2019

Conditions

Cancer

Keywords

Cancerdecisional conflictonlinedecision-aid tool

Outcome Measures

Primary Outcomes (1)

  • change (reduction) of decisional conflict (Decisional Conflict Scale)

    with the

    3 times: within 5 days after fertility preservation counseling, one month after counseling, 12 month after counseling

Secondary Outcomes (3)

  • change (reduction) of decisional regret (Decisional Regret Scale)

    twice: 1 month after fertility preservation counseling, 12 month after counseling

  • change (increase) of knowledge about fertility preservation (questionnaire)

    twice: within 5 days after fertility preservation counseling, 1 month after counseling

  • helpfulness and satisfaction of decision-aid tool (questionnaire)

    twice: within 5 days after fertility preservation counseling, 1 month after counseling

Study Arms (2)

control group

NO INTERVENTION

care as usual (fertility preservation counseling)

intervention group

EXPERIMENTAL

Intervention: use of an online decision-aid tool after fertility preservation counseling

Other: Online Decision-Aid Tool

Interventions

Online Decision-Aid ToolOTHER
intervention group

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patients
  • Age 16 to 40 years
  • German speaking
  • Access to a computer
  • Pre-menopausal at time of diagnosis
  • Not yet having started (adjuvant) cancer therapy
  • family planning not completed

You may not qualify if:

  • \- Cancer treatment not affecting reproductive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsspital Frauenklinik

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • Ehrbar V, Urech C, Rochlitz C, Zanetti Dallenbach R, Moffat R, Stiller R, Germeyer A, Nawroth F, Dangel A, Findeklee S, Tschudin S. Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation. Hum Reprod. 2019 Sep 29;34(9):1726-1734. doi: 10.1093/humrep/dez136.

    PMID: 31398258DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sibil Tschudin, PD Dr. med.

    Universitätsspital Basel Frauenklinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 1, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

CH(1)