Cancer Clinical Trial
— BUDDYOfficial 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. 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).
Status | Recruiting |
Enrollment | 254 |
Est. completion date | July 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. A cancer diagnosis, any tumor or stage 2. Computer literacy and internet access 3. Good command of the Dutch language 4. Willingness to participate in either MBCT intervention Exclusion Criteria: 1. Previous participation in MBSR or MBCT (>4 sessions) 2. Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, severe personality disorders, suicidal thoughts) 3. Alcohol or drug dependence 4. Severe cognitive impairments |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Dutch Cancer Society |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 week post-treatment | |
Secondary | 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. | 3, 6 and 9 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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) | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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. | 1 week post-treatment and 3, 6 and 12 months post-treatment | |
Secondary | 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). | 1 week post-treatment |
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