Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2023-07-11

Brief Summary

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Evaluate the impact and satisfaction of Mobile Mindfulness Meditation on anxiety, pain, fatigue, trauma, and sleep in cancer survivors.

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Detailed Description

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Through previous research, mindfulness meditation has been linked to decreases in anxiety, increased pain tolerance, better mood, and improved quality of life, in both healthy and medical populations. Although mindfulness meditation is well promoted both clinically and in the media, finding ways to promote engagement in and fidelity to the intervention, in a format that is accessible for cancer survivors is crucial, as the availability of resources and appreciation of the benefits does not necessarily lead to behavior change.

With many more people surviving cancer than in previous decades, there is an opportunity to act on the residual effects of cancer diagnosis and treatment, and with the prevalence of technology ever increasing, online and mobile interventions have become more frequently delivered and have a particular utility for this population. Physical and geographic limitations could prevent cancer survivors from accessing psychosocial interventions. Whether the repeated beneficial findings of face-to-face training in mindfulness meditation will be found in a mobile environment is an open and timely question. This intervention will include two arms: the impact of the use of the mobile app for anxiety and for cancer related neuropathy.

Conditions

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Cancer, Other Than Non-melanoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be conducted as a randomized wait-list control design, such that participants will be randomized to either begin the intervention immediately or after 8 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control/Waitlist (Anxiety Group)

Subjects assigned to this arm will not be offered access to the mobile app during the first 8 weeks of their participation. Subjects will be asked to begin using the app eight weeks after randomization. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week time point (just before subject begins using the mobile app) and 16 week time point.

Group Type ACTIVE_COMPARATOR

Mobile Mindfulness Meditation

Intervention Type BEHAVIORAL

It is hypothesized that participants who are randomized in the app condition will have significantly less anxiety, pain, fatigue, and sleep disturbance than their counterparts in the control condition.

Mindfulness App (Anxiety Group)

Subjects assigned to this arm will receive mindfulness meditation instructions for 8 consecutive weeks following randomization to this arm. The mobile app contains 14 sessions that subject can participate in at their own pace. Subjects are asked to try and practice mindfulness meditation daily, for a total time of 2 hours per week. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week and 16 week time points.

Group Type ACTIVE_COMPARATOR

Mobile Mindfulness Meditation

Intervention Type BEHAVIORAL

It is hypothesized that participants who are randomized in the app condition will have significantly less anxiety, pain, fatigue, and sleep disturbance than their counterparts in the control condition.

Control/Waitlist (Neuropathy Group)

Subjects assigned to this arm will not be offered access to the mobile app during the first 8 weeks of their participation. Subjects will be asked to begin using the app eight weeks after randomization. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week time point (just before subject begins using the mobile app) and 16 week time point.

Group Type ACTIVE_COMPARATOR

Mindfulness Coach

Intervention Type BEHAVIORAL

It is hypothesized that participants who are randomized into treatment condition will have significantly less CIPN, anxiety, and fatigue, and improved anxiety, in comparison to their counterparts in the wait-list control condition.

Mindfulness App (Neuropathy Group)

Subjects assigned to this arm will receive mindfulness meditation instructions for 8 consecutive weeks following randomization to this arm. The mobile app contains 14 sessions that subject can participate in at their own pace. Subjects are asked to try and practice mindfulness meditation daily, for a total time of 2 hours per week. Subjects assigned to this arm will complete a questionnaire at three times points: the beginning after the subject has signed the informed consent form, at the 8 week and 16 week time points.

Group Type ACTIVE_COMPARATOR

Mindfulness Coach

Intervention Type BEHAVIORAL

It is hypothesized that participants who are randomized into treatment condition will have significantly less CIPN, anxiety, and fatigue, and improved anxiety, in comparison to their counterparts in the wait-list control condition.

Interventions

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Mobile Mindfulness Meditation

It is hypothesized that participants who are randomized in the app condition will have significantly less anxiety, pain, fatigue, and sleep disturbance than their counterparts in the control condition.

Intervention Type BEHAVIORAL

Mindfulness Coach

It is hypothesized that participants who are randomized into treatment condition will have significantly less CIPN, anxiety, and fatigue, and improved anxiety, in comparison to their counterparts in the wait-list control condition.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Anxiety Arm:

1. previous diagnosis of cancer, other than non-melanoma skin cancer
2. over 21 years of age
3. routine access to the Internet
4. comfortable reading and writing in English
5. have completed primary treatment for cancer
6. indicate the presence of cancer related anxiety as indicated by the PROMIS measure
7. not currently practicing meditation regularly (more than one hour per week), and
8. diagnosed with any stage of cancer
9. own a smartphone or tablet

Cancer Related Neuropathy Arm

1. diagnosis of cancer
2. use of a taxane or platinum agent
3. experiencing CIPN, per self-report
4. over 21 years of age
5. routine access to a smart device
6. comfortable reading and writing in English, and
7. not currently practicing meditation regularly (more than one hour per week).