Cancer, Other Than Non-melanoma Skin Cancer Clinical Trial
Official title:
Mobile Mindfulness Meditation Intervention to Improve the Well-Being of Cancer Survivors
Verified date | August 2023 |
Source | University of Hawaii |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the impact and satisfaction of Mobile Mindfulness Meditation on anxiety, pain, fatigue, trauma, and sleep in cancer survivors.
Status | Completed |
Enrollment | 302 |
Est. completion date | July 11, 2023 |
Est. primary completion date | July 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Palo Alto VA Health Care System | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
University of Hawaii | VA Palo Alto Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Evaluate the satisfaction with Mobile Mindfulness Meditation as measured by questionnaires on the Online Mindful Meditation platforms (Anxiety Arm) | 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. | Baseline, 16 weeks | |
Secondary | Evaluate the satisfaction with Mindfulness Coach | Baseline, 16 weeks |