Clinical trial NCT03581357: Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors
Official title: Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Other Than Non-melanoma Skin Cancer
Keywords: Previous diagnosis of cancer, completed primary treatment of cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2018-07-10
Enrollment: 302
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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).

Exclusion Criteria:

None

Primary outcomes:
measure: Evaluate the impact of Mobile Mindful Meditation on anxiety as measured with the GAD-7 (Anxiety Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mobile Mindful Meditation on pain as measured with the PEG-3 (Anxiety Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mobile Mindful Meditation on fatigue as measured with the Brief Fatigue Inventory (Anxiety Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mobile Mindful Meditation on trauma as measured with the PCL-5 (Anxiety Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mobile Mindful Meditation on sleep as measured by the PROMIS sleep scale (Anxiety Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mindfulness Coach on pain as measured with the McGill Pain Questionnaire (Neuropathy Arm)
timeFrame: 8 weeks
measure: Evaluate the impact of Mindfulness Coach on anxiety as measured with the PROMIS anxiety (Neuropathy Arm)
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Evaluate the impact of Mindfulness Coach on fatigue as measured with the BFI (Neuropathy Arm)
timeFrame: Baseline, 8 weeks, 16 weeks
measure: Evaluate the impact of Mindfulness Coach on Quality of Life as measured with the FACT scale (Neuropathy Arm)
timeFrame: Baseline, 8 weeks, 16 weeks
Secondary outcomes:
measure: Evaluate the satisfaction with Mobile Mindfulness Meditation as measured by questionnaires on the Online Mindful Meditation platforms (Anxiety Arm)
timeFrame: Baseline, 16 weeks
measure: Evaluate the satisfaction with Mindfulness Coach
timeFrame: Baseline, 16 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto VA Health Care System
state: California
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: Erin O Bantum, PhD
role: PRINCIPAL_INVESTIGATOR
References: