This clinical trial studies whether a mindfulness-based intervention for depressive symptoms sent via text (MINDSET) works to improve symptoms of depression in breast, prostate, and colorectal cancer survivors who are post-treatment. Post-treatment cancer survivors are at a high risk for developing symptoms of depression. When left untreated, high levels of depressive symptoms can increase the risk of the cancer coming back or death. The MINDSET intervention sends text messages to a personal device containing audio recordings of a mindfulness-based intervention. The recordings encourage listeners to have an increased awareness of the present and help change their behavior by changing the way they think and feel about certain things, which may improve symptoms of depression.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06811454.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Approved
Contact: Chelsea Siwik
Phone: 216-894-0058
PRIMARY OBJECTIVES:
I. Develop a daily mindfulness-based intervention for depressive symptoms sent via text (MINDSET).
II. Conduct a single-arm study to pilot test and refine MINDSET (Study 1, N=16).
III. Conduct a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of MINDSET and enhanced usual care (EUC) control condition (Study 2, N=60).
SECONDARY OBJECTIVES:
I. Will assess the following secondary outcomes in study 1 and 2:
Ia. Symptoms of depression;
Ib. Symptoms of anxiety.
OUTLINE:
STUDY 1: Patients receive a text message at their preferred time once daily (QD) containing a link to MINDSET audio segments and listen to MINDSET audio segments over 15 minutes QD for 8 weeks. Patients also complete a survey QD for 8 weeks and a focus group over 60 minutes during follow up in support of the refinement of the MINDSET intervention.
STUDY 2: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a text message at their preferred time QD containing a link to MINDSET audio segments and listen to MINDSET audio segments over 15 minutes QD for 8 weeks.
ARM II: Patients receive a text message containing a one-page brochure summarizing publicly available information on depression self-care strategies once a week (QW) for 8 weeks.
After completion of study intervention, patients are followed for up to 4 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorChelsea Siwik
