Project Persist: mHealth for Cancer Survivorship
Condition: Symptom Management; Reduce Treatment Non-adherence
Study type: Interventional

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.
    

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.
    

Intervention name(s): Assessment only group; Intervention group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: improve symptom management; reduce treatment non-adherence