RecruitingACTRN12613000271707

Phase I pilot of a Mindfulness-Based Stress Reduction intervention for Head and Neck Cancer patients receiving treatment of curative intent.

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.


Sponsor

Beyond Blue Limited (beyondblue)

Enrollment

30 participants

Start Date

Jan 16, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Head and neck cancer and its treatments — surgery, radiation, and chemotherapy — can cause lasting changes to a person's appearance and ability to speak or swallow. These changes often lead to high levels of emotional distress and reduced quality of life. This pilot study is developing and testing a tailored version of Mindfulness-Based Stress Reduction (MBSR) — a program that teaches focused awareness and acceptance — to help head and neck cancer patients cope better during their treatment. You may be eligible if: - You are 18 years of age or older - You have been newly diagnosed with a potentially curable cancer in the head or neck region (not skin-only cancers) - You have agreed to undergo curative-intent cancer treatment at Peter MacCallum Cancer Centre in East Melbourne You may NOT be eligible if: - You are currently being treated for another cancer or a severely debilitating illness - You cannot speak or understand English adequately - You have been diagnosed with an intellectual disability, dementia, or active psychotic illness - You are already enrolled in another time-intensive study at Peter MacCallum Cancer Centre Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

Peter MacCallum Cancer Institute - East Melbourne

VIC, Australia

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ACTRN12613000271707


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