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Trial registered on ANZCTR


Registration number
ACTRN12613000271707
Ethics application status
Approved
Date submitted
1/03/2013
Date registered
6/03/2013
Date last updated
14/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I pilot of a Mindfulness-Based Stress Reduction intervention for Head and Neck Cancer patients receiving treatment of curative intent.
Scientific title
A phase I pilot trial with no comparison group to assess the feasibility and acceptability of an adapted Mindfulness-Based Stress Reduction program for Head and Neck Cancer patients undergoing radiotherapy with curative intent.
Secondary ID [1] 282036 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 288490 0
Psychosocial distress 288528 0
Condition category
Condition code
Cancer 288836 288836 0 0
Head and neck
Mental Health 288860 288860 0 0
Depression
Mental Health 288861 288861 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Mindfulness-Based Stress Reduction (MBSR) program, adapted specifically for the needs of Head and Neck Cancer patients undergoing radiotherapy.

This intervention consists of 7 sessions, lasting up to 90 minutes each, which are administered one-on-one to patients by an experienced mental health professional. In addition, these sessions are supplemented by practice at home of the skills learned in sessions.

The first session of the MBSR program is administered before patients begin radiotherapy. Radiotherapy for patients being treated with curative intent generally runs for 7 consecutive weeks. The first session will be ideally be administered one week before patients begin radiotherapy. However, due to the difficulty of aligning the start of the MBSR intervention perfectly with the patient’s idiosyncratic radiotherapy schedules, patients may start the MBSR intervention more or less than a week prior to radiotherapy.

It is our experience that patients begin to experience severe side effects from radiotherapy by week 4 of their treatment. We have designed the administration of the MBSR intervention so that patients receive the majority of the sessions of the MBSR intervention before this point, in order to give them time to familiarise themselves with the mindfulness skills being taught before they become ill. The MBSR intervention is therefore designed to be staggered so that patients receive sessions 1 to 5 of the MBSR intervention on a weekly basis, meaning they complete these sessions in week 4 of their radiotherapy treatment. We will then give patients sessions 6 and 7 on a fortnightly basis, meaning that patients will ideally finish their last session of MBSR in the week after they finish the MBSR intervention. This schedule means that patients have the maximum time to gain skills to help themselves before they become debilitated by radiotherapy side effects, but still have the support of the clinician administering the intervention throughout their whole radiotherapy treatment period. The MBSR sessions that are administered while patients are on active radiotherapy treatment do not need to be administered immediately before or after a patient's radiotherapy session, simply some time in the same week.

Patients are asked to practice the skills they have learnt from their MBSR sessions at home using a CD of mindfulness meditations, as well as practice informal mindfulness (e.g., paying full attention to a routine task like showering). Patients are asked to practice mindfulness daily. The time that patients are asked to spend meditating a day depends on the specific meditations assigned as homework in a given week; however, it is generally at least 20 minutes a day. However, it is made clear to participants that they are to do what they can manage on a day-by-day basis and to try their best.

The MBSR intervention used in this study uses the tool of mindfulness meditation to teach patients the skills of: (1) paying attention on purpose to the present moment experiences of thoughts, sensations, bodily states, and the environment; (2) with a particular attitude of openness, non-judgement, curiousness, and acceptance. Developing these skills assists with the emotional pain that can come with people's automatic tendency to relive the past, plan the future, judge their experiences, and act reflexively. The skills and understandings developed through MBSR have broad applicability for people experiencing cancer and their families/carers which includes, but is not limited to, stress reduction. Our aim is to help clients develop better coping and emotional regulation skills overall during radiotherapy, with a specific focus on addressing the changes to their body and the impact of treatment side-effects such as nausea, fatigue and pain over the course of radiotherapy.

The contents of each session are as follows:

Session 1: Introduction to Mindfulness
Introduction to components of mindfulness; personal goals and therapy contract; introduction to formal and informal meditations in session; begin home practice of formal and informal meditation and monitoring feelings.

Session 2: Breathing and Body Sensations
Explanation of breathing and mindfulness; mindfulness and radiotherapy side effects; introduction to sitting meditations; awareness exercises (triangle of awareness and pleasant events); continuation of out-of-session practice and monitoring of pleasant events.

Session 3: Stress
Explanation of stress and its effect on the body and mind; introduction to moving meditation; continuation of awareness through unpleasant events; continuation of out-of-session practice and monitoring of unpleasant events.

Session 4: Acceptance and Avoidance
Use of breathing space to regulate the autonomic nervous system; discussion of acceptance versus experiential avoidance; focus on working with difficult emotions; continuation of out-of-session practice.

Session 5: Cultivating Beneficial States of Heart and Mind
Explanation of the role of thoughts in changing emotions; difficult thoughts and stories we tell ourselves; tools for dealing with difficult thoughts through cognitive therapy and mindfulness; continuation of out-of-session practice and monitoring thoughts.

Session 6: Deepening and Expanding
Move client towards unguided, independent practice; stressful communication and assertiveness; loving-kindness meditation; choiceless awareness meditation; continuation of out-of-session practice and monitoring stressful communication.

Session 7: Moving into the World
Review of the program and initial expectations; discuss strategies for maintaining mindful practice outside of therapy; client writes a letter to their future self, which is to be sent in 3 months time.
Intervention code [1] 286644 0
Behaviour
Comparator / control treatment
N/A - Pilot trial with no control/comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288985 0
Feasibility: the MBSR intervention will be considered feasible if the majority (> 60%) of eligible HNC patients who are recruited complete at least 4 of the 7 sessions, as measured by a log of session attendance.
Timepoint [1] 288985 0
After final session with participant has been completed.
Primary outcome [2] 288986 0
Acceptability: the MBSR intervention will be considered acceptable to eligible HNC patients if the group of patients who meet the feasibility criterion do not differ significantly in demographic characteristics from those who were approached but did not participate in the study and those who began participation but did not meet the feasibility criterion. The differences will be assessed through the demographic details of age, sex, marital status, living situation, education level, employment status, income, ethnic background and language background. This will be assessed through referral to the patient's hospital records.
Timepoint [2] 288986 0
Baseline.
Primary outcome [3] 288987 0
Compliance: patients will be considered to have complied with the MBSR intervention if they practice meditation outside of the therapeutic sessions 3 times or more a week, as measured by patient's self-report in a homework diary.
Timepoint [3] 288987 0
After final session with participant has been completed.
Secondary outcome [1] 301501 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) will be related to with higher levels of self-reported mindfulness, as measured by the Five-Factor Mindfulness Questionnaire total score.
Timepoint [1] 301501 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [2] 301502 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to lower levels of mood-disturbance, as measured by the Profile of Mood States - Adult Short Form depression-dejection and tension-anxiety subscales.
Timepoint [2] 301502 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [3] 301503 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to higher cancer-related quality of life, as measured by the Functional Assessment Cancer Therapy – Head and Neck module.
Timepoint [3] 301503 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [4] 301504 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to lower levels of intrusive thoughts, as measured by the Impact of Events Scale – Revised intrusion subscale.
Timepoint [4] 301504 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [5] 301505 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to lower levels of stress, as measured by the Perceived Stress Scale total score.
Timepoint [5] 301505 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [6] 301506 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to higher levels of self-compassion, as measured by the Self-Compassion Scale total score.
Timepoint [6] 301506 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [7] 301507 0
Following the MBSR intervention, compliance (measured dichotomously, with patients either practicing an average of at least 3 days of mindfulness a week and meeting compliance, or practicing an average of less than that amount and not meeting compliance) and/or higher levels of self-reported mindfulness (measured by the Five-Factor Mindfulness Questionnaire) will be related to lower levels of cancer-related shame and stigma, as measured by the Shame and Stigma Scale.
Timepoint [7] 301507 0
This outcome will be assessed 1 week after each participant has completed the intervention.
Secondary outcome [8] 301508 0
Self-reported mindfulness, as measured by the Five-Factor Mindfulness Questionnaire, will increase between baseline and post-intervention.
Timepoint [8] 301508 0
This outcome will be assessed before each patient has started the intervention (up to 3 weeks prior to the first MBSR session) and 1 week after each participant has completed the intervention.

Eligibility
Key inclusion criteria
Eligibility for participation in this study is a diagnosis for the first time of a potentially curable cancer in the head and neck region (excluding cancers exclusively involving skin), where the patient has agreed to undertake cancer treatment with curative intent the recruiting site, Peter MacCallum Cancer Centre East Melbourne. Eligibility of patients to participate will be evaluated by oncologists and/or the nurse co-coordinator. Participants must also be aged 18 years or older at the time of recruitment to be considered for inclusion in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient will not be eligible for this study if they are being actively treated for another cancer; or another severely debilitating illness, cannot speak or understand English adequately, or have been diagnosed with an intellectual disability, dementia or active psychotic illness. Participants who have been recruited into other time-intensive studies at the recruiting site, Peter MacCallum Cancer Centre, will not be approached to participate in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a phase I pilot intervention, there is no randomisation component. All participants enrolled in the study will receive the MBSR intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is a phase I pilot intervention, there is no randomisation component. All participants enrolled in the study will receive the MBSR intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
As this is a phase I pilot intervention, there is no randomisation component. All participants enrolled in the study will receive the MBSR intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility and compliance will be assessed using a frequency count of those people who met the criterion versus those who did not. Acceptability will be assessed using independent samples t-tests to compare the group who met feasibility to the group that did not participate or who did not meet feasibility. Change in self-reported mindfulness between baseline and post-intervention will be assessed using a paired-samples t-test. The secondary outcomes assessed post-intervention will be primarily assessed using independent samples t-tests (for compliance as a predictor of the other measures) or bivariate correlations (for mindfulness as a predictor of the other measures).

Bivariate correlations (for continuous or ordinal variables) or independent samples t-tests or univariate ANOVAs (for nominal variables) will be conducted between demographic characteristics such as age, gender, education level, type of treatment and cancer stage, and the outcome variables listed above. If these demographic characteristics have a strong (> .30) relationship (as assessed through r or eta-squared values) with any outcome, they will be considered as covariates for analyses using that outcome, and t-tests will be conducted as general linear models (such as repeated measures ANCOVA) and correlations as hierarchical linear regressions or a non-parametric equivalent if covariates are to be included. Significance for each analysis will be assumed at 0.05 to ensure that any small effect sizes are not missed, despite the increased rate of Type 2 errors.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2013
Actual
16/01/2013
Date of last participant enrolment
Anticipated
3/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 705 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 6449 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 286825 0
Charities/Societies/Foundations
Name [1] 286825 0
Beyond Blue Limited (beyondblue)
Country [1] 286825 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Beyond Blue Limited (beyondblue)
Address
PO Box 6100
Hawthorn West
VIC 3122
Country
Australia
Secondary sponsor category [1] 285616 0
None
Name [1] 285616 0
Address [1] 285616 0
Country [1] 285616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288891 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288891 0
Locked Bag 1
A'Beckett Street
Victoria 8006
Ethics committee country [1] 288891 0
Australia
Date submitted for ethics approval [1] 288891 0
Approval date [1] 288891 0
24/10/2012
Ethics approval number [1] 288891 0
12/89

Summary
Brief summary
This research project is a Phase I pilot study which aims to develop and manualise a version of Mindfulness-Based Stress Reduction (MBSR) suitable for individual administration to Head and Neck Cancer (HNC) patients during the active stage of cancer treatment of curative intent. Members of our research team have previously demonstrated that HNC patients receiving treatment of curative intent reach a threshold of clinically significant distress both immediately prior to and during treatment, and also experience a decline in health-related quality of life (HRQoL) in the weeks following treatment. These findings are consistent with previous research which has shown that patients experience high levels of distress following the chronic functional impairment and disfigurement that is a common outcome of treatment for HNCs, and points to the need for effective psychological interventions to assist coping during and following treatment for HNCs. MBSR, as demonstrated by another of our team members, has shown success in reducing psychological distress associated with other forms of cancer, including breast and prostate cancer. As no reported studies exist that use MBSR with HNC patients, we intend to evaluate whether MBSR may be suitable for use in this population. We also aim to establish whether participants’ levels of psychological distress, HRQoL, mindfulness attention and awareness, intrusive cognitions, self-compassion and shame can be effectively measured in this setting. We plan to examine the feasibility (assessed through the feasibility of and compliance and fidelity to the intervention) and acceptability of MBSR therapy to participants through examining the accrual and attrition rates for this pilot study, and further explore participant’s experiences, both positive and negative, of MBSR through a post-intervention semi-structured interview. Finally, we aim to see whether MBSR delivered by a suitably qualified and experienced mental health professional is applicable and feasible for use in a hospital context.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38190 0
Dr Jeremy Couper
Address 38190 0
Locked Bag 1
A'Beckett Street
Victoria 8006
Country 38190 0
Australia
Phone 38190 0
+61 3 96561828
Fax 38190 0
+61 3 96561095
Email 38190 0
[email protected]
Contact person for public queries
Name 38191 0
Jeremy Couper
Address 38191 0
Locked Bag 1
A'Beckett Street
Victoria 8006
Country 38191 0
Australia
Phone 38191 0
+61 3 96561828
Fax 38191 0
+61 3 96561095
Email 38191 0
[email protected]
Contact person for scientific queries
Name 38192 0
Jeremy Couper
Address 38192 0
Locked Bag 1
A'Beckett Street
Victoria 8006
Country 38192 0
Australia
Phone 38192 0
+61 3 96561828
Fax 38192 0
+61 3 96561095
Email 38192 0
[email protected]

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