- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126642
Project Persist: mHealth for Cancer Survivorship (Persist)
November 13, 2023 updated by: University of Oklahoma
Many studies have shown that anxiety and depression are associated with reduced treatment adherence and poor treatment outcomes among patients undergoing cancer treatments.
Given the negative consequences of psychological symptoms for cancer patients, it is important to effectively identify and address emotional distress among cancer patients.
However, many barriers exist that limit access to effective treatments.
Mobile health (mHealth) technologies offer the potential for remote monitoring and on demand management of psychological needs among cancer patients.
This pilot randomized controlled trial (RCT) will assess the initial feasibility of a phone-delivered intervention for anxiety and depressive symptoms among cancer patients that are receiving active radiation treatments.
A total of 60 participants will be randomized to in-person and smartphone-based assessment only (n=30) or assessment plus smartphone-based intervention (n=30).
Both groups will be followed for 8 weeks (6 weeks while undergoing radiation therapy for breast or gynecological cancer + 2 weeks following radiation therapy).
It is expected that patients who are randomized to the intervention group will report that the smartphone app is easy to use, app content is useful, and will show greater improvements in reported anxiety, depression, and quality of life compared with the assessment only group.
Data from this pilot study will be used to inform the development of mHealth interventions that will be tested in future fully powered RCTs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 60 individuals will be recruited from the OU Medicine Radiation Oncology Clinic (radiation clinic).
All participants will be adults who are beginning radiation treatments for breast, gynecological, and head and neck cancers.
Eligible participants include adult males and females 18+ who are: 1) community dwelling, 2) diagnosed with a primary breast or gynecological or head and neck cancer, 3) ordered to receive radiation treatments during a minimum of 6 consecutive weeks, and 4) able to read at the 7th grade level, speak, and write English.
Exclusion criteria include: 1) radiation treatment with primary palliative intent, 2) radiation treatment protocol occurring in a time period of less than 6 weeks, 3) severe visual impairment that limits mobile technology use (e.g, partial or full blindness), and 4) history of dementia or other major neurocognitive disorder.
Potential participants will be referred to this study for screening from multiple sources including from radiation clinic staff and self-referral.
Eligible participants will be identified by radiation oncologists and other radiation clinic staff during initial consult visit, who will alert study staff of potential participants.
Flyers will also be used to advertise the study to potential study participants, who can discuss enrollment with radiation oncologists.
Those interested in participating in this study will complete the informed consent process.
Those who meet the study inclusion criteria will be randomized into the assessment only group (n=30) or the assessment + intervention group (n=30).
All participants will complete a baseline assessment visit which includes completion of study questionnaires, downloading the study smartphone app onto personal or study provided smartphones, and training to complete the phone based surveys (EMAs).
Consent, baseline assessment, and mobile health training will take place in a private or semi-private space in the radiation clinic and is estimated to take 60-90 minutes to complete.
Radiation oncology providers will be blinded to patient group assignment, which will occur during the baseline visit.
Participants will complete EMAs for 8 weeks.
At the end of the 8-week data collection period, participants will complete a final study survey using the study smartphone application and participate in a telephone interview.
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael S Businelle, Ph.D
- Phone Number: 50460 4052718001
- Email: michael-businelle@ouhsc.edu
Study Contact Backup
- Name: Audrey Montgomery, MEd.
- Phone Number: 50479 4052718001
- Email: audrey-montgomery@ouhsc.edu
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Eligible participants include adults 18+ who are:
- community dwelling
- diagnosed with a primary breast or gynecological or head and neck cancer
- ordered to receive radiation treatments during a minimum of 5-6 consecutive weeks
- able to read at the 7th grade level, speak, and write English.
- scheduled for 5-6 weeks of radiation therapy
Exclusion Criteria:
- radiation treatment with primary palliative intent
- radiation treatment protocol occurring in a time period of less than 6 weeks
- severe visual impairment that limits mobile technology use (e.g, partial or full blindness)
- history of dementia or other major neurocognitive disorder. There are no early termination criteria; however, individuals can elect to stop participation in mobile monitoring at any time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Assessment only group
Standard care + Daily ecological momentary assessments (EMAs)
|
Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.
|
Experimental: Intervention group
Intervention group will receive same measures and interventions as the assessment only group AND will receive messaging that is tailored to patient responses on EMAs.
When participants provide a pattern of responses that are suggestive of heightened emotional distress, they will receive feedback and/or a prompt to complete one of the self-management exercise.
The app will prompt participants to complete a brief educational video on relaxation strategies and guided relaxation exercises.
Participants will have access to: 1) a "Help me Cope" button in the app that contains links to evidenced-based self-management techniques, and 2) a "Contact Counselor" button that will send a secure email to a study psychologist requesting a call.
Participants will receive a coping focused message at the completion of the "Report Distress" EMAs.
Participants can access these on demand intervention components and review them at any time in addition to receiving the tailored intervention messages.
|
Individuals randomized to the intervention group will complete the same measures (in person and daily EMAs) as the assessment only group, but will additionally receive messaging that is tailored to patient responses on EMAs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of anxiety and depression in intervention group compared with the assessment only control group
Time Frame: 8 weeks
|
The study plans to assess the differences between the 8 week and baseline values of scores from validated scales for evaluating anxiety (GAD7) and depression (PHQ and CESD).
Exact 95% confidence intervals will be estimated for the difference between the 8 week and baseline scores in the intervention and control groups.
The scale scores for anxiety and depression obtained from the EMA measurements will also be modeled, which are correlated within participants.
Thus, we will use linear mixed model regression analysis (LMM) on these repeated measures, employing a random intercept or slope parameter, as appropriate, to examine changes in these measures over time in the two treatment groups.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2020
Primary Completion (Actual)
October 19, 2023
Study Completion (Actual)
October 19, 2023
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 13, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 11273
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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