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Effectiveness of Blended and Unguided Delivery of Mindfulness-based Cognitive Therapy for Cancer Patients

NCT05336916 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2022-05-13

No results posted yet for this study

Summary

Rationale: Approximately one in three cancer patients and survivors experience significant psychological distress. Previous research has shown that mindfulness-based interventions such as mindfulness-based cognitive therapy (MBCT) can help reduce distress among cancer patients. However, MBCT typically takes place in face-to-face group sessions, which are not easily accessible to many cancer patients. Blended therapist-assisted (combination of group sessions and individual online sessions) and unguided online MBCT interventions may address this problem, however, research on effectiveness of these interventions is missing.

Objective: This three-armed, randomized controlled trial (RCT) evaluates the effectiveness and cost-effectiveness of blended therapist-assisted (blended MBCT) and unguided individual internet-based MBCT (online MBCT) compared to treatment-as-usual (TAU) for cancer patients. Secondly, consolidation of treatment effects is studied up to nine months post-treatment. Thirdly, possible working mechanisms and effect moderators are studied.

Study design: The current study is a RCT with three arms (blended MBCT, online MBCT and TAU) with assessments at baseline (T0), mid-treatment, post-treatment (T1) and 3 months follow-up (T2). At 3 months follow-up (T2), patients in the TAU arm will be crossed over to blended MBCT or online MBCT (random allocation). Uncontrolled follow-up assessments will be conducted at 6 (T3) and 9 months (T4) follow-up.

Study population: 254 adults (\>18 years) who have or have had a cancer diagnosis (any stage/any type) will be randomized.

Intervention: Patients will be randomly assigned with a 1:1:1 ratio to one of three groups: (1) blended MBCT: patients will be invited to a blended therapist-assisted MBCT program, consisting of 8 weekly sessions (4 online group meetings, 4 online sessions with therapist assistance, and an online silent day), in addition to TAU; (2) online MBCT: patients will be invited to an individual internet-based MBCT program without assistance from a therapist, that consists of 8 weekly sessions and a silent day, in addition to TAU; (3) TAU: patients receive usual care, which can be medical, psychological or paramedical care, except mindfulness interventions.

Main study parameters/endpoints: Primary outcome is the difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the blended MCBT and TAU arms and between the online MCBT and TAU arms post-treatment (T1).

Conditions

Interventions

BEHAVIORAL

Buddy

Mindfulness-based Cognitive Behavioural Therapy

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-01-31
Completion
2023-07-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05336916 on ClinicalTrials.gov