Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05837169 |
| Other study ID # |
ECA-MIND |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 23, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Medicos e Investigadores en la Lucha contra el Cancer de Mama |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The diagnosis and treatment of breast cancer (BC) can drastically affect the quality of life
of patients with this disease by causing symptoms of vasomotor disorders, insomnia,
depression and anxiety. Mindfulness-Based Stress Reduction (MBSR) is a program dedicated to
fostering complete awareness in the present in order to accept the moment, thereby reducing
stress. Previous studies have shown that MBSR benefits patients with chronic conditions such
as mood disorders and chronic pain, as well as patients with BC. However, its usefulness in
Mexican patients has not been previously studied.
Description:
This is a prospective, randomized clinical study, controlled by a wait-list group and blinded
to the statistician, with the main objective of evaluating whether an MBSR intervention
offered virtually allows reducing the levels of anxiety of BC survivors.
The randomized design will make it possible to compare participants' levels of anxiety,
depression, fear of recurrence, and physical symptoms according to whether they participate
in a virtual MBSR program or do not. In addition, the randomized design will reduce the
possible impact of confounding variables, facilitating direct comparison between the two
groups.
Invitation to the study will be made through social networks of Mexican civil associations
and through the dissemination of the study by specialists in oncology. It will be done this
way because the intervention through an online mindfulness program can be delivered to a
considerable volume of BC survivors with internet access, regardless of their place of
residence or medical care.
Participants will be assigned to the intervention group or the wait-list control group. Those
randomized to the control group will not receive the MBSR intervention during the study
period, while those randomized to the intervention group will participate in a virtual MBSR
program, which is described below. A wait-list control group will be used with the aim that
all participants have the opportunity to receive the MBSR intervention and at the same time
allow comparison of the effect of the program with a group without intervention. Given that
anxiety has a significant negative impact on people's well-being, it is appropriate to offer
the control group the possibility of receiving an intervention if its effectiveness is
demonstrated. The control group will be assessed with the study surveys at baseline, will not
receive MBSR intervention for the following 8 weeks, and will subsequently be reassessed with
the study surveys at the same time points as the intervention group. At the end of the
recruitment and follow-up of all the participants, the study will end and the control group
will be able to receive the MBSR intervention free of charge according to the preference of
the participants.
BC survivors will be invited to participate through an electronic link with a selection
questionnaire asking about the inclusion and exclusion criteria. In particular, the General
Anxiety Disorder-7 (GAD-7) tool will allow for anxiety screening in order to determine if
those interested in participating have the minimum level of anxiety required to be included
in the study. Through that same electronic link, those who meet the eligibility criteria will
be invited to read and sign the electronic informed consent. Those who accept will be
randomly assigned to the intervention group or control group, in a 1:1 ratio considering a
stratification according to the severity of anxiety measured by GAD-7 (moderate vs. severe)
and menopausal status (pre- vs. post-menopause) in the questionnaire. of selection. Likewise,
they will be asked for contact information (i.e., telephone and email) in order to send them
the study surveys (participants in both groups) and the electronic links for the MBSR program
sessions (participants in the intervention group). At this baseline time (T1), participants
randomized to either group will answer the study surveys to assess symptoms of anxiety,
depression, and fatigue.
Subsequently, the intervention group will participate in the online MBSR intervention for 8
weeks, while the control group will be registered on a waiting list and will be able to
receive the intervention once the study is finished. For both the intervention group and the
control group, the online MBSR program will be offered free of charge.
Participants will answer the study surveys again 1 week (T2), 3 months (T3) and 6 months (T4)
after completing the online mindfulness program. In the case of participants randomized to
the control group, these times correspond to 9 weeks (T2), 5 months (T3) and 8 months (T4) of
follow-up. Additionally, in T2 the participants randomized to the intervention group will
answer a satisfaction survey with the online MBSR program. At the end of the recruitment and
follow-up of the participants, the study will end and those randomized to the control group
by waiting list will be able to receive the MBSR intervention online if they wish.
