CancerBUDDYNCT05336916
Effectiveness of Blended and Unguided Delivery of Mindfulness-based Cognitive Therapy for Cancer Patients
A study testing Buddy in people with Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Buddy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jan 2021to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A cancer diagnosis, any tumor or stage
- Computer literacy and internet access
- Good command of the Dutch language
- Willingness to participate in either MBCT intervention
Who cannot join
- Previous participation in MBSR or MBCT (>4 sessions)
- Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, severe personality disorders, suicidal thoughts)
- Alcohol or drug dependence
- Severe cognitive impairments
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Linda Kwakkenbos, PhD, 0243668456, linda.kwakkenbos@radboudumc.nl
About this study
Official title: (Cost)Effectiveness of Blended and UnguideD DeliverY of Mindfulness-based Cognitive Therapy Versus Care as Usual for Cancer Patients: BUDDY Project
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.
Read more
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).
Read the detailed description
About one in three cancer patients experience significant levels of psychological distress, requiring intervention from a health professional. Unfortunately, however, many cancer patients experiencing psychological symptoms do not receive treatment.
Effective psychological treatments for cancer patients are available. Evidence for the effectiveness of mindfulness-based interventions (MBIs) such as Mindfulness-based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) in oncology has rapidly increased. MBIs have beneficial effects on depression symptoms, anxiety, fear of cancer recurrence and fatigue. Also, preliminary results indicate that MBIs are cost-effective in cancer care.
However, there are known patient-reported barriers to engaging in face-to-face psychological interventions, such as investment of time, stigma, reluctance to return to the hospital, and indirect costs. In contrast, internet-based interventions are easily accessible and save travelling time. Evidence of over 100 trials suggests that internet-based treatments can be as effective as face-to-face treatments for psychiatric and somatic conditions. MBIs are also being delivered via Internet, but research on internet-based MBIs (eMBIs) has been mostly conducted in the general population.
Studies on the effectiveness of eMBIs in cancer patients are scarce. Our team conducted the first RCT comparing group MBCT and individual internet-based MBCT with TAU in patients with cancer. Therapist-assisted individual internet-based MBCT was similar to group MBCT in terms of treatment protocol, but took place individually and was guided one-on-one by a therapist on a weekly basis. Results indicated that both group MBCT and individual internet-based MBCT were significantly effective in reducing psychological distress in cancer patients compared to TAU. Moreover, both interventions significantly increased secondary quality-of-life outcomes with small to moderate effect sizes. Patients further improved over the course of the 9 months post-treatment, with patients who were less conscientious and less mindful at baseline benefitting more from therapist-assisted individual internet-based MBCT than group MBCT. Cost-effectiveness analyses demonstrated dominance of both interventions compared to TAU, indicating both higher quality of life and lower societal costs. In short, individual internet-based MBCT rendered MBCT much more accessible for cancer patients without compromising intervention efficacy or societal costs.
However, the proportion of patients receiving a lower dosage of MBCT than intended was substantially higher in individual internet-based MBCT than in group MBCT and although cost-effective, the individual internet-based MBCT proved to be resource intensive in terms of therapist assistance. Moreover, patients mentioned lack of peer support and the asynchronous communication with their therapist as important disadvantages of individual internet-based MBCT. Consequently, there is room to improve individual internet-based MBCT prior to implementation to ensure adherence and scalability.
To improve adherence and scalability, the investigators have developed two new versions of the effective online MBCT program with therapist assistance in a co-creation process together with relevant stakeholders. To improve adherence, a blended therapist-assisted MBCT (blended MBCT) was developed, combining four online group sessions with a therapist with four individual therapist-assisted online sessions. Furthermore, to improve scalability, unguided individual internet-based MBCT (online MBCT), which is similar to the previously studied individual internet-based MBCT protocol but without therapist guidance was also developed. As adherence to unguided interventions often is lower than intended, persuasive technology known to improve adherence was included, such as reminders and virtual coaches.
The current study primarily aims to investigate the effectiveness and cost-effectiveness of blended MBCT and online MBCT in comparison to treatment-as-usual (TAU) in a randomized controlled trial (RCT). Secondly, the aim is to test the consolidation of treatment effects up to nine months post-treatment. Thirdly, the investigators want to investigate working mechanisms and treatment effect moderators, to address how these programs work, and for whom.
The aim is to include 254 patients who were diagnosed with cancer (any stage, any tumor). After baseline assessment, patients will be randomized to the blended MBCT, unguided online MBCT or TAU (1:1:1 ratio). Outcome assessment for the RCT will occur at baseline (T0), immediately post-treatment (T1; primary endpoint) and three months follow-up (T2). Patients participating will also receive follow-up questionnaires at 6 months (T3) and 9 months (T4) post-treatment. At week 5 of both interventions (and at the same time during TAU), patients will be invited to complete a mid-treatment assessment, to look at working mechanisms. At 3 months follow-up (T2), patients in TAU will be randomized to the blended MBCT or unguided online MBCT.
- Conditions
- Cancer
- Being tested
- Buddy
- Keywords
- Cancer, Mindfulness-based Cognitive Therapy (MBCT), Blended intervention, eHealth
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuddyBehavioural
Mindfulness-based Cognitive Behavioural Therapy
| Study group | Role | What they receive |
|---|---|---|
| Blended MBCT | Experimental | The blended MBCT consists of four 2,5 hour group sessions through videoconference (session 1, 3, 5 and 8), taught by experienced mindfulness trainers. The other sessions (2, 4, 6 and 7) are delivered online and are individual. Mindfulness trainers will provide online feedback to participants for these sessions. The sessions include meditation exercises, psycho-education, and group discussion. In addition to the sessions, participants are instructed to do daily home practice 45 minutes a day. The regular MBCT program was adapted to fit the needs of the target group and, for instance includes psycho-education about grief and cancer-related fatigue.
Online sessions were built around a specific theme. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. The sessions look appealing and persuasive technologies such as reminders and videos are used. Receives: Behavioral: Buddy |
| Unguided online MBCT | Experimental | Participants in the unguided online arm receive access to the 8 online mindfulness sessions (same intervention as blended MBCT arm), but no mindfulness trainer will be involved.
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. Receives: Behavioral: Buddy |
| Treatment As Usual | No intervention | Not offered the mindfulness program, treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The HADS is a 14-item questionnaire measuring distress. Items are scored on a 0-3 scale that are summed to obtain a distress total score (range 0-42). Higher scores represent more distress.
Measured: 1 week post-treatment
Secondary outcomes (11)
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The HADS is a 14-item questionnaire measuring distress. Items are scored on a 0-3 scale that are summed to obtain a distress total score (range 0-42). Higher scores represent more distress.
Measured: 3, 6 and 9 months post-treatment
Difference in Fear of Cancer Recurrence Inventory (FCRI) severity subscale scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The 9-item Fear of Cancer Recurrence Inventory severity subscale assesses fear of cancer recurrence on a 5-point Likert scale ranging from 0 (not at all or never) to 4 (a great deal or all the time). Higher scores indicate higher levels of FCR.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Checklist Individual Strength (CIS)- Fatigue scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
The 8-item CIS-Fatigue Severity measures the patient's fatigue levels over the past 2 weeks on a 7-point scale, with higher scores indicating higher levels of fatigue.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Rumination and Reflection Questionnaire (RRQ) rumination subscales scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
Rumination will be measured using the rumination 12-item subscale of the Rumination and Reflection Questionnaire. Items are scored on a five-point rating scale, with higher scores indicating more rumination.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The 24-item Five Facet Mindfulness Questionnaire Short Form assesses mindfulness skills and consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience and non-reactivity to inner experience. Items are scored on a five-point rating scale (1 = rarely true, 5 = always true). Higher scores are indicative of someone who is more mindful in their everyday life.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Decentering subscale of the Experiences Questionnaire scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The 11-item Decentering subscale of the Experiences Questionnaire measures the ability to observe one's thoughts and feelings as temporary, objective events in the mind. Participants rate items on a 5-point Likert scale (1 = never to 5 = always). Higher scores indicate greater decentering ability.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Self-Compassion Scale Short Form (SCS-SF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The Self-compassion Scale-Short Form is a 12-item self-report measure that is used to measure people's capacity for self-compassion. Items are scored on a five-point Likert scale (0 = 'Almost never' to 5 = 'Almost always') to record how often you behave kindly and caringly towards yourself in difficult life situations. Higher scores reflect higher levels of self-compassion.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Mental Health Continuum-Short Form (MHCSF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The 14-item MHCSF measures positive mental health, consisting of three subscales: 1) emotional well-being, 2) psychological well-being, and 3) social well-being. Items assess the frequency with which respondents experience each symptom of positive mental health on a 6-point Likert scale ranging from 0 "never" to 5 "everyday" Higher scores indicate greater levels of positive well-being.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in EuroQol-5D-5L (EQ-5D) index scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The EQ-5D is a generic instrument comprising five domains with five levels: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D index is obtained by applying predetermined weights to the five domains. This index gives a societal-based global utility score of the participant's health status on a scale with 0 (death) and 1 (perfect health)
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in the Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P) between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P) will be used to collect information on direct healthcare use (e.g. general practitioner, mental healthcare and hospital day care visits) and paid and informal work-related productivity losses. Higher scores indicate greater healthcare use and productivity losses.
Measured: 1 week post-treatment and 3, 6 and 12 months post-treatment
Engagement with the intervention will be measured with Twente Engagement with Ehealth Technologies Scale (TWEETS) among participants in the blended and online MCBT arms
The TWEETS consists of 9 items, divided over 3 subscales: behavioural engagement, cognitive engagement and affective engagement. On a scale of 1 to 5, participants indicate the extent to which they agree with statements such as "I think I will be able to use this [technology] as often as needed [to achieve my goals]" (behavioural engagement), "this [technology] will motivate me to [goal of the technology]" (cognitive engagement) or " I think I will enjoy using this [technology]" (affective engagement).
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start20 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336916
- Sponsor's protocol ID
- NL73117.091.20
- Acronym
- BUDDY
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Publications
Badaghi N, Kwakkenbos L, Prins J, Donders R, Kelders S, Speckens A. Randomized Controlled Trial of Group-Blended and Individual-Unguided Online Mindfulness-Based Cognitive Therapy to Reduce Psychological Distress in People With Cancer. Psychooncology. 2025 Sep;34(9):e70286. doi: 10.1002/pon.70286.
PubMed 40968786Badaghi N, van Kruijsbergen M, Speckens A, Vile J, Prins J, Kelders S, Kwakkenbos L. Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial. JMIR Form Res. 2024 Feb 21;8:e52338. doi: 10.2196/52338.
PubMed 38381493Badaghi N, van Kruijsbergen M, Prins J, Kelders S, Cillessen L, Compen F, Donders R, Kwakkenbos L, Speckens A. Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial. BMC Psychol. 2023 Jan 25;11(1):21. doi: 10.1186/s40359-023-01052-2.
PubMed 36698197
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost)Effectiveness of Blended and UnguideD DeliverY of Mindfulness-based Cognitive Therapy Versus Care as Usual for Cancer Patients: BUDDY Project
- ClinicalTrials.gov ID
- NCT05336916
- Acronym / sponsor ID
- BUDDY / NL73117.091.20
- Conditions
- Cancer
- Keywords
- Cancer, Mindfulness-based Cognitive Therapy (MBCT), Blended intervention, eHealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
About one in three cancer patients experience significant levels of psychological distress, requiring intervention from a health professional. Unfortunately, however, many cancer patients experiencing psychological symptoms do not receive treatment.
Effective psychological treatments for cancer patients are available. Evidence for the effectiveness of mindfulness-based interventions (MBIs) such as Mindfulness-based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) in oncology has rapidly increased. MBIs have beneficial effects on depression symptoms, anxiety, fear of cancer recurrence and fatigue. Also, preliminary results indicate that MBIs are cost-effective in cancer care.
However, there are known patient-reported barriers to engaging in face-to-face psychological interventions, such as investment of time, stigma, reluctance to return to the hospital, and indirect costs. In contrast, internet-based interventions are easily accessible and save travelling time. Evidence of over 100 trials suggests that internet-based treatments can be as effective as face-to-face treatments for psychiatric and somatic conditions. MBIs are also being delivered via Internet, but research on internet-based MBIs (eMBIs) has been mostly conducted in the general population.
Studies on the effectiveness of eMBIs in cancer patients are scarce. Our team conducted the first RCT comparing group MBCT and individual internet-based MBCT with TAU in patients with cancer. Therapist-assisted individual internet-based MBCT was similar to group MBCT in terms of treatment protocol, but took place individually and was guided one-on-one by a therapist on a weekly basis. Results indicated that both group MBCT and individual internet-based MBCT were significantly effective in reducing psychological distress in cancer patients compared to TAU. Moreover, both interventions significantly increased secondary quality-of-life outcomes with small to moderate effect sizes. Patients further improved over the course of the 9 months post-treatment, with patients who were less conscientious and less mindful at baseline benefitting more from therapist-assisted individual internet-based MBCT than group MBCT. Cost-effectiveness analyses demonstrated dominance of both interventions compared to TAU, indicating both higher quality of life and lower societal costs. In short, individual internet-based MBCT rendered MBCT much more accessible for cancer patients without compromising intervention efficacy or societal costs.
However, the proportion of patients receiving a lower dosage of MBCT than intended was substantially higher in individual internet-based MBCT than in group MBCT and although cost-effective, the individual internet-based MBCT proved to be resource intensive in terms of therapist assistance. Moreover, patients mentioned lack of peer support and the asynchronous communication with their therapist as important disadvantages of individual internet-based MBCT. Consequently, there is room to improve individual internet-based MBCT prior to implementation to ensure adherence and scalability.
To improve adherence and scalability, the investigators have developed two new versions of the effective online MBCT program with therapist assistance in a co-creation process together with relevant stakeholders. To improve adherence, a blended therapist-assisted MBCT (blended MBCT) was developed, combining four online group sessions with a therapist with four individual therapist-assisted online sessions. Furthermore, to improve scalability, unguided individual internet-based MBCT (online MBCT), which is similar to the previously studied individual internet-based MBCT protocol but without therapist guidance was also developed. As adherence to unguided interventions often is lower than intended, persuasive technology known to improve adherence was included, such as reminders and virtual coaches.
The current study primarily aims to investigate the effectiveness and cost-effectiveness of blended MBCT and online MBCT in comparison to treatment-as-usual (TAU) in a randomized controlled trial (RCT). Secondly, the aim is to test the consolidation of treatment effects up to nine months post-treatment. Thirdly, the investigators want to investigate working mechanisms and treatment effect moderators, to address how these programs work, and for whom.
The aim is to include 254 patients who were diagnosed with cancer (any stage, any tumor). After baseline assessment, patients will be randomized to the blended MBCT, unguided online MBCT or TAU (1:1:1 ratio). Outcome assessment for the RCT will occur at baseline (T0), immediately post-treatment (T1; primary endpoint) and three months follow-up (T2). Patients participating will also receive follow-up questionnaires at 6 months (T3) and 9 months (T4) post-treatment. At week 5 of both interventions (and at the same time during TAU), patients will be invited to complete a mid-treatment assessment, to look at working mechanisms. At 3 months follow-up (T2), patients in TAU will be randomized to the blended MBCT or unguided online MBCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blended MBCT | Experimental | Behavioral: BuddyThe blended MBCT consists of four 2,5 hour group sessions through videoconference (session 1, 3, 5 and 8), taught by experienced mindfulness trainers. The other sessions (2, 4, 6 and 7) are delivered online and are individual. Mindfulness trainers will provide online feedback to participants for these sessions. The sessions include meditation exercises, psycho-education, and group discussion. In addition to the sessions, participants are instructed to do daily home practice 45 minutes a day. The regular MBCT program was adapted to fit the needs of the target group and, for instance includes psycho-education about grief and cancer-related fatigue. Online sessions were built around a specific theme. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. The sessions look appealing and persuasive technologies such as reminders and videos are used. |
| Unguided online MBCT | Experimental | Behavioral: BuddyParticipants in the unguided online arm receive access to the 8 online mindfulness sessions (same intervention as blended MBCT arm), but no mindfulness trainer will be involved. 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. |
| Treatment As Usual | No intervention | –Not offered the mindfulness program, treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A cancer diagnosis, any tumor or stage
- Computer literacy and internet access
- Good command of the Dutch language
- Willingness to participate in either MBCT intervention
Key exclusion criteria (4 listed)
- Previous participation in MBSR or MBCT (>4 sessions)
- Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, severe personality disorders, suicidal thoughts)
- Alcohol or drug dependence
- Severe cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuddyMindfulness-based Cognitive Behavioural Therapy | Behavioural | Blended MBCT, Unguided online MBCT |
Primary outcome
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment
The HADS is a 14-item questionnaire measuring distress. Items are scored on a 0-3 scale that are summed to obtain a distress total score (range 0-42). Higher scores represent more distress.
11 secondary outcomes
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 3, 6 and 9 months post-treatment
Difference in Fear of Cancer Recurrence Inventory (FCRI) severity subscale scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Checklist Individual Strength (CIS)- Fatigue scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Rumination and Reflection Questionnaire (RRQ) rumination subscales scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Decentering subscale of the Experiences Questionnaire scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Self-Compassion Scale Short Form (SCS-SF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Mental Health Continuum-Short Form (MHCSF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in EuroQol-5D-5L (EQ-5D) index scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in the Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P) between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
Time frame: 1 week post-treatment and 3, 6 and 12 months post-treatment
Engagement with the intervention will be measured with Twente Engagement with Ehealth Technologies Scale (TWEETS) among participants in the blended and online MCBT arms
Time frame: 1 week post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 40968786Badaghi N, Kwakkenbos L, Prins J, Donders R, Kelders S, Speckens A. Randomized Controlled Trial of Group-Blended and Individual-Unguided Online Mindfulness-Based Cognitive Therapy to Reduce Psychological Distress in People With Cancer. Psychooncology. 2025 Sep;34(9):e70286. doi: 10.1002/pon.70286.
- Derived from this study: PubMed 38381493Badaghi N, van Kruijsbergen M, Speckens A, Vile J, Prins J, Kelders S, Kwakkenbos L. Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial. JMIR Form Res. 2024 Feb 21;8:e52338. doi: 10.2196/52338.
- Derived from this study: PubMed 36698197Badaghi N, van Kruijsbergen M, Prins J, Kelders S, Cillessen L, Compen F, Donders R, Kwakkenbos L, Speckens A. Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial. BMC Psychol. 2023 Jan 25;11(1):21. doi: 10.1186/s40359-023-01052-2.
- Individual participant dataSharing planned: Yes. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buddy in people with Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne EM Speckens, MD, PhD ((024) 366 84 56, anne.speckens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU (time frame: 1 week post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336916, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.