My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System. Eligible patients will be directly contacted by the study team for recruitment.
The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.
Participants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
My Wellbeing Guide
BehavioralThe intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.
Treatment groups
6,516 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in depressive symptoms will be evaluated with the Patient-Reported Outcomes Measurement Information System Depression
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire is a previously validated patient-report measure of depressive symptoms in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of depression.
Time frame
T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)Secondary outcomes
1
Change in anxiety will be evaluated with the Patient-Reported Outcomes Measurement Information System Anxiety
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire is a previously validated patient-report measure of symptoms of anxiety in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of anxiety.
Time frame
T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)2
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy - General - 7 item version (FACT-G7)
The Functional Assessment of Cancer Therapy - General - 7 item version (FACT-G7) has been used extensively to measure Health Related Quality of Life (HRQoL). The FACT-G7assesses participant's wellbeing in physical, emotional, social, and functional concerns in the last seven days using a five-point response scale. Scores range from 0-28, with higher scores indicating better quality of life.
Time frame
T1 (prior to starting intervention), T2 (7 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post-intervention)Sponsors and contacts
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Northwestern University
Lead sponsor
University of Miami
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov