Clinical trial NCT05647785: Long-term Follow-up of RESTORE Study
Official title: Extension Study to Compare Long-term Efficacy of Two Digital Software Medical Devices as Interventions for Physical and Mental Health in Cancer Patients Previously Enrolled in the RESTORE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: Blue Note Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of all interested patients who were enrolled and not withdrawn from the parent study (RESTORE).

Brief summary: The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898).

The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.

Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.


Eligibility criteria: Inclusion Criteria:

* Enrolled in and not withdrawn from the original RESTORE study

Primary outcomes:
measure: Symptoms of anxiety
timeFrame: 3 and 6 months post RESTORE end-of-study
Secondary outcomes:
measure: Symptoms of depression
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Symptoms of emotional distress
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Cancer-related symptoms of anxiety (intrusions)
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Wellbeing and quality of life
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Stress management/coping skills
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Non-specific (social) intervention effects
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Perceived stress
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Benefit finding
timeFrame: 3 and 6 months post RESTORE end-of-study
Other outcomes:
measure: Fear of cancer recurrence
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Healthcare utilization - visits and admissions
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Healthcare utilization - hospitalizations
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Healthcare utilization - medications
timeFrame: 3 and 6 months post RESTORE end-of-study
measure: Healthcare utilization - claims and costs
timeFrame: 3 and 6 months post RESTORE end-of-study
Locations:
city: San Francisco
country: United States
facility: Blue Note Therapeutics
state: California
Study officials:
affiliation: Blue Note Therapeutics
name: Dianne M Shumay, PhD
role: PRINCIPAL_INVESTIGATOR
References: