Comparison of the Effectiveness of Mindfulness-Based Cognitive Therapy and Usual Care in Reducing Anxiety and Improving Quality of Life in Patients with Kidney Cancer

The aim of this study is to examine the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in reducing anxiety and improving quality of life in patients with kidney cancer.

This study is a randomized, parallel, single-blind clinical trial. Kidney cancer patients will be randomly assigned via Randomization.com to either the intervention group (MBCT in eight weekly 120-minute sessions) or the control group (usual care without structured psychotherapy). The sample includes 32 participants (16 per group) and the trial is Phase II.

Study Location: Psychological Sciences House Clinic, Mashhad, Iran. Study Population: Eligible patients diagnosed with kidney cancer. Blinding Type: Single-blind. Blinding Method: Participants, outcome assessor, and data analyst are unaware of group allocation.

Inclusion criteria: Confirmed kidney cancer, high anxiety (STAI), ≥6 months since diagnosis with ongoing disease, age 40–60 years and written informed consent. Exclusion criteria: Complete cancer recovery, psychiatric medication use within 3 months, psychotherapy within 6 months, personality disorder or psychotic symptoms and uncontrolled pain at baseline.

Intervention Group: Participants attend 8 weekly MBCT sessions (120 minutes each), including mindfulness practices, home exercises, and brief CBT-based skills. Control Group: Participants receive no intervention during the study and continue their usual care. For ethical reasons, MBCT will be offered to them after the study post-test.

State and trait anxiety score based on the Spielberger State–Trait Anxiety Inventory (STAI); Health-related quality of life score based on the World Health Organization Quality of Life questionnaire (WHOQOL)

Randomization will be performed using the website https://www.randomization.com. The random allocation list will be generated by a statistician who is not involved in the implementation or assessment of the study. Variable block randomization with block sizes of 4 and 6 will be used to maintain balance in the number of participants between the Mindfulness-Based Cognitive Therapy (MBCT) group and the no-intervention control group. Allocation codes will be placed in opaque, sealed, sequentially numbered envelopes to ensure concealment of the random sequence until the moment of assignment. Upon each participant’s entry into the study, the envelope corresponding to their order of enrollment will be opened by the registration officer, and the participant will be assigned to the appropriate group.

This study was designed as a single-blind trial with participant and outcome-assessor blinding. Participants were not informed of their allocation to either the Mindfulness-Based Cognitive Therapy (MBCT) group or the control group, and they were not told which intervention condition they would receive. Psychological outcomes (including anxiety and quality of life) were assessed by evaluators who were blinded to the randomization sequence and group assignments. In addition, statistical analyses were conducted by a data analyst who received group labels in coded and anonymized form and was therefore unaware of the intervention status of each participant. Only the therapist was aware of group allocations in order to deliver the intervention. Participants, outcome assessors, and the data analyst had no direct knowledge of the randomization process or its results.

A data dictionary describing the structure of the dataset (variable names, coding schemes such as intervention group=1 and control group=0, score ranges for psychological instruments, and time points such as pre-test and post-test) will be made available after completion of data collection and publication of the primary results. This file contains only variable definitions and coding rules; it does not include any identifiable participant information.

It will be available after completion of data collection and publication of the main study results in a scientific journal.

Access will be granted only to qualified researchers who provide a written request and formally agree to a confidentiality commitment.

These data/documents may be used only for scientific and research purposes, such as methodological review, replication of the statistical analyses, or comparison with similar studies. Use for commercial purposes, attempts to re-identify participants, or any use outside a research context is not permitted. Access and use are conditional on a written commitment to confidentiality and non-disclosure.

Requests should be directed to the Principal Investigator of the study: Hossein Salimi Bajestani, Assistant professor. Email: H.salimi.b@gmail.com. Access will be considered after scientific review of the request and a signed confidentiality commitment.

The requester must submit a written request to the Principal Investigator, including the research purpose, the specific data/document requested, and the intended use. The request will be reviewed for scientific merit and ethical compliance to ensure that use is strictly research-oriented and does not compromise participant confidentiality. If the request is approved, the requester will be asked to sign a confidentiality and non-disclosure agreement. After this agreement is signed, the shareable version of the data/document (with no identifying information) will be provided.