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IMPACT (IMproving Proactive Approaches for Cancer Survivors' Mental Health Treatment)

Evaluation of a Proactive Identification and Digital Mental Health Intervention Approach to Address Unmet Psychosocial Needs of Individuals Living With Likely Incurable Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will complete electronic questionnaire measures throughout the study period."
  • "Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Moodivate, a phone app to help treat depression in cancer survivors with signs of depression. The study lasts about 12 weeks, and everyone fills out online surveys. Participants are placed by chance into a group that gets the app or a group that does not.

The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors. Moodivate was developed by our research team to assist with the treatment of depressed mood. Participants will be randomly assigned to either download the mobile app, "Moodivate", or not. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will not. All participants will complete electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as your experiences using Moodivate and participating in this trial. Participation in this study will take about 12 weeks, beginning today. Participation in this study may help in the treatment of future cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality. Alternative treatments include contacting your primary care provider or your oncology care team to discuss other available treatments for depressed mood.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Meet the ILLIC requirement, checked through medical records. The listing does not explain what ILLIC means.
  • Score 8 or higher on the PHQ-9, a survey about depression symptoms.
  • Own an iPhone or an Android-compatible smartphone.
  • Be willing to use a phone app to help treat depressed mood.
  • Have a working email address you check often, or regular access to text messages.
  • Be fluent in English.

Who can't join

  • Have current thoughts of suicide at screening, based on a score of 1 or higher on question 9 of the PHQ-9.
  • Have severe trouble with memory or thinking that prevents informed consent, meaning understanding the study and agreeing to join. The study checks for a past diagnosis of dementia or major neurocognitive disorder, or reported thinking problems that make it hard to live independently.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age \> 18 years * ILLIC (as determined during manual chart review) * Elevated depressive symptoms, defined as a score of ≥ 8 on the PHQ-9 * Current owner of an iOS- or Android-compatible smartphone * Willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item) * Have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments) * English language fluency Exclusion Criteria: * Current suicidal ideation at study screening, defined as a response greater than or equal to 1 on item nine of the PHQ-9 * Severe cognitive impairment that precludes completion of informed consent. For the purposes of assessing eligibility, this criterion is operationalized as: * Prior diagnosis of dementia, or Major Neurocognitive Disorder indicated either via self-report or in the EHR; or * Self-report of cognitive difficulties that impair functional independence

Study sites (1)

SC