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

NCT03581357 | Completed DMC

• 1 other identifier: Bantum-2017-1
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cancer, Other Than Non-melanoma Skin Cancer

Keywords

Previous diagnosis of cancer, completed primary treatment of cancer

Outcome Measures

Primary Outcomes (9)

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

  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."

  8 weeks

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

  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").

  8 weeks

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

  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"

  8 weeks

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

  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.

  8 weeks

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

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

  8 weeks

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

  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.

  8 weeks

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

  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.

  Baseline, 8 weeks, 16 weeks

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

  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.

  Baseline, 8 weeks, 16 weeks

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

  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.

  Baseline, 8 weeks, 16 weeks

Secondary Outcomes (2)

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

  Baseline, 16 weeks

• Evaluate the satisfaction with Mindfulness Coach

  Baseline, 16 weeks

Study Arms (4)

Control/Waitlist (Anxiety Group)

ACTIVE COMPARATOR

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.

Behavioral: Mobile Mindfulness Meditation

Mindfulness App (Anxiety Group)

ACTIVE COMPARATOR

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.

Behavioral: Mobile Mindfulness Meditation

Control/Waitlist (Neuropathy Group)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Coach

Mindfulness App (Neuropathy Group)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Coach

Interventions

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.

Control/Waitlist (Anxiety Group); Mindfulness App (Anxiety Group)

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.

Control/Waitlist (Neuropathy Group); Mindfulness App (Neuropathy Group)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Hawaii: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (2)

Palo Alto VA Health Care System

Palo Alto, California, 94304, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

• Orasud AS, Uchiyama M, Pagano I, Bantum E. Mobile Mindfulness Meditation for Cancer-Related Anxiety and Neuropathy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 12;13:e47745. doi: 10.2196/47745.

  PMID: 38345843 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Erin O Bantum, PhD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 10, 2018
• Study Start: April 3, 2019
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)