Symptom ManagementPersistNCT04126642
Project Persist: mHealth for Cancer Survivorship
A study testing Assessment only group and Intervention group in people with Symptom Management and Reduce Treatment Non-adherence, run by University of Oklahoma at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Symptom Management, Reduce Treatment Non-adherence
- What is being tested?
- Assessment only group and Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the 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.
- Conditions
- Symptom Management, Reduce Treatment Non-adherence
- Being tested
- Assessment only group, Intervention group
- Keywords
- improve symptom management, reduce treatment non-adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment only groupBehavioural
Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.
Intervention groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment only group | Other | Standard care + Daily ecological momentary assessments (EMAs) Receives: Behavioral: Assessment only group |
| Intervention group | Experimental | 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. Receives: Behavioral: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of anxiety and depression in intervention group compared with the assessment only control group
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start27 Jul 2020
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ManagementStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126642
- Sponsor's protocol ID
- 11273
- Acronym
- Persist
- Status last verified
- Nov 2023
- First submitted
- 18 Sep 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Persist: mHealth for Cancer Survivorship
- ClinicalTrials.gov ID
- NCT04126642
- Acronym / sponsor ID
- Persist / 11273
- Conditions
- Symptom Management, Reduce Treatment Non-adherence
- Keywords
- improve symptom management, reduce treatment non-adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assessment only group | Other | Behavioral: Assessment only groupStandard care + Daily ecological momentary assessments (EMAs) |
| Intervention group | Experimental | Behavioral: Intervention groupIntervention 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment only groupIndividuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments. | Behavioural | Assessment only group |
| Intervention groupIndividuals 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. | Behavioural | Intervention group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment only group and Intervention group in people with Symptom Management and Reduce Treatment Non-adherence, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of anxiety and depression in intervention group compared with the assessment only control group (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.