Project Persist: mHealth for Cancer Survivorship

NCT04126642 | Completed

• 1 other identifier: 11273
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Symptom Management; Reduce Treatment Non-adherence

Keywords

improve symptom management; reduce treatment non-adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

Assessment only group

OTHER

Standard care + Daily ecological momentary assessments (EMAs)

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.

Behavioral: Intervention group

Interventions

Assessment only group BEHAVIORAL

Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.

Assessment only group

Intervention group BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Study Design

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

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 15, 2019
• Study Start: July 27, 2020
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

US (1)