Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05715255
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-01-27
Brief Title:
Adaptive Symptom Self-Management Immunotherapy Study
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of immune checkpoint inhibitors ICIs alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events irAEs common 90 during ICI treatment Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to health care providers HCPs may reduce irAE severity by early recognition and management resulting in fewer treatment interruptions and unscheduled health services
Detailed Description:
Using a sequential multiple assignment randomized trial SMART design the study team will initially randomize 286 diverse survivors 30 Hispanic who are within 12 weeks of starting ICIs and who also have elevated psychological distress to an Automated Telephone Symptom Management ATSM or to an active control condition ATSM consists of weekly telephone symptom monitoring using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events PRO-CTCAE items by an automated voice response technology Participants are referred to a printed Handbook with information about symptoms evidence-based self-management strategies and when to report symptoms to HCPs ATSM automatically sends a weekly symptom summary to HCPs Active control survivors will receive automated symptom monitoring only with reports sent to HCPs Survivors in ATSM whose psychological distress is still elevated for 2 consecutive weeks during weeks 2-8 nonresponders will be randomized for the second time to add TIPC for 8 weeks or continue with ATSM alone The study team hypothesizes adding TIPC will improve self-efficacy for symptom self-management including communication with HCPs and increase social support resulting in lower indices of psychological distress other PRO-CTCAE symptoms clinician-documented irAES primary outcomes and unscheduled health services use and ICI treatment interruptions secondary outcomes With total intervention time of 16 weeks all survivors will be interviewed at baseline and week 17 post-intervention and electronic health record data will be extracted for the participation period
Specific aims
Aim 1 Determine if primary and secondary outcomes over weeks 1-17 are lower better in the group created by the first randomization the adaptive intervention that begins with ATSM with the need-based addition of TIPC vs active control group
Aim 2 Among those not responding to ATSM on psychological distress during weeks 2-8 who enter the second randomization determine a if primary and secondary outcomes over weeks 8-17 are lower better in TIPCATSM vs ATSM alone group b the extent to which the effects of adding TIPC to ATSM on primary and secondary outcomes are mediated by increased social support self-efficacy for symptom management and for communication with HCP
Aim 3 Explore which baseline characteristics of the survivor cancer and cancer treatment are associated with optimal primary and secondary outcomes resulting from three supportive care options 1 symptom monitoring only with automated reports to HCPs active control 2 ATSM alone for 16 weeks or 3 addition of 8 weeks of TIPC to ATSM if no response on psychological distress during weeks 2-8
Specific aims
Aim 1 Determine if primary and secondary outcomes over weeks 1-17 are lower better in the group created by the first randomization the adaptive intervention that begins with ATSM with the need-based addition of TIPC vs active control group
Aim 2 Among those not responding to ATSM on psychological distress during weeks 2-8 who enter the second randomization determine a if primary and secondary outcomes over weeks 8-17 are lower better in TIPCATSM vs ATSM alone group b the extent to which the effects of adding TIPC to ATSM on primary and secondary outcomes are mediated by increased social support self-efficacy for symptom management and for communication with HCP
Aim 3 Explore which baseline characteristics of the survivor cancer and cancer treatment are associated with optimal primary and secondary outcomes resulting from three supportive care options 1 symptom monitoring only with automated reports to HCPs active control 2 ATSM alone for 16 weeks or 3 addition of 8 weeks of TIPC to ATSM if no response on psychological distress during weeks 2-8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA263714-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA263714-01A1 |