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Completed

NCT Number: NCT03581357

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

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

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Key information

Conditions

Cancer, Other Than Non-melanoma Skin Cancer Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto VA Health Care System, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Anxiety Arm:

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

Cancer Related Neuropathy Arm

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

Exclusion criteria

None

Treatment and study plan

Mobile Mindfulness Meditation

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 Coach

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.

Primary outcomes

  1. Evaluate the impact of Mobile Mindful Meditation on anxiety as measured with the GAD-7 (Anxiety Arm)

    Time frame: 8 weeks

    Anxiety will be measured with the GAD-7, which entails respondents indicating how much in the past week they experienced anxiety. Participants are asked to provide their responses on a 5-point Likert type scale, with options ranging from "never" to "always."

  2. Evaluate the impact of Mobile Mindful Meditation on pain as measured with the PEG-3 (Anxiety Arm)

    Time frame: 8 weeks

    Pain will be measured with the PEG-3, a three item measure assessing pain intensity, interference with general activity, and interference with enjoyment of life, with response options ranging from a 0-10 scale (0 being "no pain" or "does not interfere" and 10 being "pains as bad as you can imagine" or "completely interferes").

  3. Evaluate the impact of Mobile Mindful Meditation on fatigue as measured with the Brief Fatigue Inventory (Anxiety Arm)

    Time frame: 8 weeks

    Fatigue will be measured with the Brief Fatigue Inventory, a 9-item measure where respondents are asked to rate their fatigue on an 11-point scale, with options on three items ranging from either "no fatigue" to "as bad as you can imagine" and options on the remaining items ranging from "does not interfere" to "completely interferes"

  4. Evaluate the impact of Mobile Mindful Meditation on trauma as measured with the PCL-5 (Anxiety Arm)

    Time frame: 8 weeks

    Trauma Symptoms will be measured with the PCL-5. This 20-item measure assess for the 20 DSM-5 symptoms of PTSD, which fit into the larger categories of intrusive and avoidant symptoms.

  5. Evaluate the impact of Mobile Mindful Meditation on sleep as measured by the PROMIS sleep scale (Anxiety Arm)

    Time frame: 8 weeks

    Sleep will be measured by the PROMIS sleep scale, an 8-item measure, with 5-point response choices.

  6. Evaluate the impact of Mindfulness Coach on pain as measured with the McGill Pain Questionnaire (Neuropathy Arm)

    Time frame: 8 weeks

    This is a self-report questionnaire, consisting of 3 major classes of word descriptors--sensory, affective/emotional impact and cognitive evaluation of pain. The Short-form McGill Pain Questionnaire (SFMPQ) was developed to provide an instrument that could be completed in less time than the MPQ but would still reflect both the sensory and affective dimensions of pain and has been shown to have high correlations with the original McGill Pain Scale.

  7. Evaluate the impact of Mindfulness Coach on anxiety as measured with the PROMIS anxiety (Neuropathy Arm)

    Time frame: Baseline, 8 weeks, 16 weeks

    This is a 22 item measure created for cancer survivors to measure both symptoms of anxiety and whether help was needed due to anxiety symptoms65. This is included at all time-points as an additional outcome measure.

  8. Evaluate the impact of Mindfulness Coach on fatigue as measured with the BFI (Neuropathy Arm)

    Time frame: Baseline, 8 weeks, 16 weeks

    The Brief Fatigue Inventory (BFI) is a 15-item measure assessing both the severity of fatigue and the impact of fatigue on daily functioning64. This is included at all three time-points as an additional outcome measure.

  9. Evaluate the impact of Mindfulness Coach on Quality of Life as measured with the FACT scale (Neuropathy Arm)

    Time frame: Baseline, 8 weeks, 16 weeks

    The FACT-GOC-Ntx scale includes 11 additional items (27 original items and 11 CIPN items) to measure the severity and impact of chemotherapy induced peripheral neuropathy. This data will serve as both a screening tool and baseline measure of CIPN.

Secondary outcomes

  1. Evaluate the satisfaction with Mobile Mindfulness Meditation as measured by questionnaires on the Online Mindful Meditation platforms (Anxiety Arm)

    Time frame: Baseline, 16 weeks

    Patient self-reporting through the Mobile Mindful Meditation platform will measure satisfaction via the Five Facet Mindfulness Questionnaire. Successfully completing the 8-week program will also be an indirect measure of patient satisfaction.

  2. Evaluate the satisfaction with Mindfulness Coach

    Time frame: Baseline, 16 weeks

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • VA Palo Alto Health Care System

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 10, 2018
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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