|- candidate number||14158|
|- NTR Number||NTR3771|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jan-2013|
|- Secondary IDs||NL34511091.10 CCMO|
|- Public Title||My Home GMC: (online) Group Medical Consultations for breast cancer survivors.|
|- Scientific Title||The (cost)effectiveness of Group Medical Consultations (GMCs) and dedicated iPads in the Follow-up after Breast Cancer Treatment.|
|- ACRONYM||My Home GMC|
|- hypothesis||The research question is whether GMCs in combination with My Home GMC compared to usual care is effective in reducing psychological distress and/or improving empowerment. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer, E-health, Follow-up, Distress, Empowerment|
|- Inclusion criteria||1. Histologically proven breast cancer;|
2. A minimum age of 18 years;
3. Completed primary treatment maximally five years ago.
|- Exclusion criteria||1. Currently involved in a diagnostic work-up because of a suspicion of breast cancer, either primary or metastatic;|
2. Metastatic cancer;
3. Current psychiatric disorder precluding consultations in a group;
4. Insufficient command of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-mrt-2012|
|- planned closingdate||1-jun-2014|
|- Target number of participants||130|
|- Interventions||The intervention group will participate in a GMC once, followed by the provision of dedicated iPads (My Home GMC), while the control group will receive usual care (an individual visit).
In principle, the content of a GMC is similar to an individual visit, except for the presence of maximally 8 other patients. The GMC will last for approximately 90 minutes. Physical examinations will be performed before the start of the group consultation. During a GMC a clinician and social worker or a nurse are collaborating.|
Afterwards patients have access to My Home GMC (dedicated iPads), including several communication media with contact information of other participants from the GMC. Several virtual video group meetings will be organized, where patients can meet the other participants from the GMC in the presence of a nurse. During these virtual meetings, patients can address their own discussion topics. Additional documents (via iBooks) and 13 short videos with information concerning survivorship are available at My Home GMC. Also, suggestions for publicly available, survivorship relevant internet sites are given.
|- Primary outcome||Psychological distress (SCL-90) and empowerment (Cancer Empowerment Questionnaire).|
|- Secondary outcome||1. Fear of recurence - CWS;|
2. QoL –EORTC-QLQ C30 + BR23;
3. Health outcome – EQ-5D;
4. Costs – TiC-P;
5. Satisfaction (patient & care provider);
6. Information need;
7. Medication adherence (MARS).
Besides questionnaires also the (online) GMCs will be observed and usage statistics from My Home GMC will be measured.
|- Timepoints||Participants will be asked to fill out questionnaires at four time points: At baseline, 1 week after, 3 months and 6 months after the (group or individual) consultation. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. A. Visser|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.B. Prins|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||During follow-up, breast cancer survivors (BCS) generally have a high need for psychosocial support and information, while the number of consultations decreases. Therefore, we have introduced specially programmed iPads (My Home GMC). Using this iPad, patients have access to information and videos and they can contact peer patients, as well as health care professionals by several communication channels, including virtual group meetings. A prerequisite for successful telecare is the existence of a relationship prior to online meetings. Therefore, patients first participate in a group medical consultation (GMC) in the hospital. GMCs provide individual medical visits conducted within a group. These (online) group-visits with ~8 patients allow patients to spend more time with their clinician and a behavioral health professional, as well as to learn from other patients who are dealing with similar issues. This approach provides a unique combination of both social support and professional education in an eHealth environment. However, it should be noted that (online) group sessions may increase distress and anxiety. Therefore, the effectiveness of GMCs and My Home GMC for BCS will be evaluated in a non-blinded multicenter randomized controlled trial.
130 BCS will be included. The intervention group will participate in a GMC once, followed by the provision of dedicated iPads (My Home GMC), while the control group will receive usual care (an individual visit). Changes in self-report questionnaires from baseline to 1 week, 3 months and 6 months after the consultation will be measured. Primary outcomes are empowerment (CEQ) and psychological distress (SCL-90). Besides questionnaires the use of My Home GMC and the content and frequency of communication will be measured. |
The strength of My Home GMC is the additional attention for psychosocial related problems and interaction with other BCS, which will, as we hypothesize, lead to more empowerment and a decrease in distress.
|- Main changes (audit trail)|
|- RECORD||4-jan-2013 - 12-jan-2013|