A) Follow-up of breast cancer patientsPrimary research question1.In the follow-up of breast cancer patients: does a group medical consultation (GMC) increase patient empowerment compared to a regular individual visit and/or does it decrease…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
n.a.
Secondary outcome
n.a.
Background summary
A group medical consultation (GMC), or shared medical appointment, is an
innovative way of consultation. During a GMC the healthcare worker provides a
series of one-to-one consultations in a group of ~10 patients; the group is
facilitated by a behavioral health professional. These group appointments
provide patients with the opportunity to spend extended time with their care
providers, while sharing in an interactive setting and learning from other
patients. This may improve patient care compared to an individual consultation.
However, group sessions may also work out negatively and increase patient
distress. Therefore, before introducing GMCs in regular patient care the value
of GMCs for specific patient populations should carefully be evaluated. In this
research project we will evaluate the value of GMCs in the follow-up of breast
cancer survivors and the surveillance of women with a BRCA mutation.
Study objective
A) Follow-up of breast cancer patients
Primary research question
1.In the follow-up of breast cancer patients: does a group medical consultation
(GMC) increase patient empowerment compared to a regular individual visit
and/or does it decrease psychological distress?
Secondary research questions
1.In the follow-up of breast cancer patients does a GMC compared to a regular
individual visit:
a) decrease fear of breast cancer?
b) improve transfer of information?
c) improve adherence to hormonal treatment?
d) improve patient satisfaction?
e) improve caregiver satisfaction?
2.In the follow-up of breast cancer patients is a GMC cost effective compared
to a regular individual visit?
B) Surveillance of BRCA mutation carriers
Primary research question
1.In the surveillance of women with a BRCA mutation: does a group medical
consultation (GMC) increase patient empowerment compared to a regular
individual visit and/or does it decrease psychological distress?
Secondary research questions
1.In the surveillance of women with a BRCA mutation does a GMC compared to a
regular individual visit:
a) decrease fear of breast cancer?
b) improve transfer of information?
c) improve adherence to self-control of the breasts?
d) change the decision for a prophylactic mastectomy or surveillance?
e) improve patient satisfaction?
f) improve caregiver satisfaction?
2.In the surveillance of women with a BRCA mutation is a GMC cost effective
compared to a regular individual visit?
Study design
Two separate randomized controlled trials will be performed for patients in
follow-up after breast cancer and women with a BRCA mutation. In the
experimental group women will participate in a GMC instead of a regular
individual visit; in the control group women will have their regular individual
visit.
Intervention
GMC versus regular individual consultation
Study burden and risks
n.a.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Participants: patients in follow-up after breast cancer
Women >= 18 years of age with histologically proven breast cancer.
Primary treatment (surgery, radiotherapy, chemotherapy) completed maximally 5 years ago. ;Participants: women with a BRCA mutation
Women >= 25 years of age with a proven BRCA1 or BRCA2 mutation.
Carrier of a BRCA1 or BRCA2 mutation, diagnosed maximally two years before inclusion.
Exclusion criteria
Participants: patients in follow-up after breast cancer
Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
A history of prophylactic mastectomy.
Current psychiatric disease precluding consultations in a group.
Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire. ;Participants: women with a BRCA mutation
Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic.
A history of prophylactic mastectomy.
Current psychiatric disease precluding consultations in a group.
Insufficient command of the Dutch language to be able to follow a group discussion and/or to fill out a Dutch questionnaire.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL34511.091.10 |
OMON | NL-OMON23985 |