(Cost)Effectiveness of blended and unguided delivery of Mindfulness-based Cognitive Therapy versus Care as Usual for cancer patients: BUDDY project.

Rationale: Around one in three cancer patients and survivors experience
significant psychological distress. Previous research showed that
mindfulness-based interventions such as mindfulness-based cognitive therapy
(MBCT) can help cancer patients to relieve their distress. However, MBCT takes
place in face-to-face group sessions, which are not easily accessible to all
cancer patients. Blended (combination of face-to-face and online sessions) and
online MBCT interventions may address this problem, however, research on
effectiveness of these interventions is missing.

Hypotheses: We expect both blended and unguided MBCT to be effective in
improving psychological distress and secondary (positive) outcomes compared to
TAU, both at our primary endpoint, the three month follow-up, and during the
nine month follow-up. Moreover, we expect both interventions to be
cost-effective compared to TAU and unguided MBCT to compare favorably to
blended MBCT in terms of cost-effectiveness. Analyses regarding potential
treatment moderators are exploratory. Finally, we expect that both mindfulness
and self-compassion can be identified as working mechanisms.

Primary Objective:
• Are blended MBCT and unguided online MBCT more effective than TAU in reducing
psychological distress (primary outcome), and other psychological complaints
and physical symptoms, and in increasing quality of life?

Secondary Objective(s):
• Are blended MBCT and unguided online MBCT cost-effective in comparison to TAU
in terms of societal costs and QALYs at three month follow-up?
• Do the treatment effects of blended MBCT and unguided online MBCT consolidate
over the course of an uncontrolled nine month follow-up?
• Are treatment effects moderated by differences in demographics, cancer or
personality variables or patient expectations?
• Are mindfulness and self-compassion (assessed mid-treatment) working
mechanisms of blended MBCT and unguided online MBCT?

Main study
We will conduct a randomized controlled trial (RCT) with three arms: blended
MBCT, unguided online MBCT and TAU (see Figure 1 for a flowchart). After
baseline assessment, patients will be randomized to one of these three groups.
In case patients are randomized to TAU, they will also hear whether they will
received blended MBCT or unguided online MBCT after the TAU period.

Before the start of the RCT, an explorative mixed-methods pilot study will be
conducted. Twenty-four cancer patients will be randomized to either blended
MBCT or unguided online MBCT. They will complete questionnaires before and
after participation. In addition, semi-structured interviews will be conducted.
With information and data from this study, both interventions will be improved
for the main RCT.

Blended or standalone online Mindfulness-Based Cognitive Therapy (MBCT):

MBCT is originally a manualised group skills-training program, designed as a
relapse prevention program for patients with recurrent depression. The training
consists of eight weekly sessions of 2.5 hours, plus one six-hour day of silent
practice. The sessions include meditation exercises (formal: bodyscan, sitting
meditation, gentle movement exercises; and informal: e.g. three minute
breathing space, daily activities with attention), psycho-education, and group
discussion. Psycho-education included information on cognitive techniques, like
monitoring and scheduling of events and identification of negative automatic
thoughts. In addition to the sessions, participants are instructed to do daily
home practice 45 minutes a day. Home practice consists of meditations and
registration exercises. We have adapted the regular MBCT program to fit the
needs of the target group. For instance, we have included psycho-education
about grief and cancer-related fatigue. Based on the results of phase 1 of this
study, other minor adaptations to the intervention for the specific target
group will be made if necessary.

In our study, the intervention will be delivered in a blended format, or
standalone online format. The blended format consists of three group sessions
(representing session 1, 5 and 8). The other sessions are delivered online and
are individual. In the standalone online format, all sessions are online and
individual. Each online session was built around a specific theme, for instance
automatic pilot, communication or self-care. Participants are provided with
information, audio files of meditations, and recording assignments around the
theme of the session through a personal, secure webpage. Participants are
encouraged to read the information and do the assigned meditations and
recording assignments within one week. The sessions will look appealing and
persuasive technologies such as reminders and video*s will be used.

The group sessions in the blended format will be taught by experienced
mindfulness trainers that are health care professionals and have experience in
psycho-oncology. All mindfulness trainers fulfill the advanced criteria of the
UK Network for Mindfulness-Based teachers and of the Association of Mindfulness
Based Teachers in the Netherlands and Flanders. In the blended format,
mindfulness trainers will provided weekly feedback on the registrations of the
participants, on a set day of the week. In the standalone online format, no
mindfulness trainer will be involved.
Patients can participate in both interventions alone, or together with a
significant other (e.g. partner, close friend or relative).

This study involves adapted versions of a therapeutic intervention that is
effective for cancer patients and survivors (9). Participation is free of
charge. We believe that the risks of participation are negligible. However, we
will be watchful of potential adverse reactions to blended or unguided online
MBCT, participants can contact the researchers during the intervention period
when necessary. Participants are encouraged to respect their boundaries (both
physical and psychological) and are always free to suspend or adapt the
practice as needed. The burden associated with participation in MBCT is
relatively high: consisting of 8 weekly group sessions of 2,5 hours and one
silent day (6 hours), and home practice of about 45 minutes a day.
Participation includes 4 (blended MBCT and unguided online MBCT) or 6 (TAU
followed by blended MBCT or unguided online MBCT) online self-report
questionnaire assessments of 1 hour. During the intervention period, short
weekly assessments are also included. Although the effort requested from
patients is quite high, we expect that practicing mindfulness will be
associated with enduring changes in patients' coping strategies in daily life,
and as a result, can increase participants' autonomy and self-efficacy.
Furthermore, we reduced burden on participants with online delivery of all
assessments, reducing travel efforts.