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Adaptive Symptom Self-Management Immunotherapy Study

Primary Purpose

Breast Cancer, Colon Cancer, Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)
Active control comparator
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Cancer, Cancer Survivors, Immunotherapy, Immune Checkpoint Inhibitors, Symptom Management, Psychosocial Oncology, Telephone Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 or older Within 12 weeks after starting ICI treatment for cancer Cognitively oriented to person, place and time (determined by recruiter) Able to speak and understand English or Spanish Access to a telephone Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library Exclusion Criteria: Currently receiving regular behavioral counseling

Sites / Locations

  • University of Arizona Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive Intervention

Active Control

Arm Description

The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.

Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.

Outcomes

Primary Outcome Measures

Change in patient reported psychological distress in Interviews.
Patient Reported Outcomes Measurement Information System (PROMIS) has been developed using sophisticated measurement techniques, tested with over 21,000 individuals, calibrated to produce t-scores based on the general population and are available in either English or Spanish. The available short forms have evidence of good reliability and validity. PROMIS-short form 8 for depression and anxiety will be administered at baseline and 17-week telephone interviews to provide greater detail and precision in the measurement of severity of these symptoms, as compared to three PRO-CTCAE items (anxious, discouraged, sad). Each question is rated on a five-point scale from 1=Never to 5=Always. A higher score indicates higher anxiety or depression.The study team chose 8-item short forms to minimize respondent burden while maintaining measurement precision.
Change in reported PRO-CTCAE Symptoms
Psychological distress and other symptoms will be measured weekly using PRO-CTCAE severity items at weeks 0-17. Severity is rated 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The 3 items reflecting psychological distress are anxious, discouraged, and sad. Other items relevant to ICI treatment were selected from the PRO-CTCAE library for a total of 23 items (e.g., nausea, vomiting, constipation, diarrhea, swelling, rash, increased sweating, heart palpitations, etc.). In addition to PRO-CTCAE, the study team will use data on the grades of irAEs documented by clinicians in the HER. Each of 3 item sets, the three PRO-CTCAE items of psychological distress, 23 other PRO-CTCAE items, and clinician documented irAEs will be summarized into three toxicity indices (TIs). All grades of the included items will be ordered from highest to lowest, and the weighted sum will be calculated.

Secondary Outcome Measures

Change in cancer treatment interruptions
Cancer treatment interruptions (dose reductions and stoppages) along with their dates will be extracted from EHRs and summarized as the number and duration of temporary stoppages and dose reductions, and whether or not a premature permanent or temporary stoppage of the ICI occurred during the 17-week study period.
Change in unscheduled health care visits
Unscheduled health care visits, hospitalizations and emergency department visits will be summarized as the number of events and number of days spent in the hospital if admitted.

Full Information

First Posted
January 27, 2023
Last Updated
May 25, 2023
Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05715255
Brief Title
Adaptive Symptom Self-Management Immunotherapy Study
Official Title
Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 TIPC+ATSM 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colon Cancer, Lung Cancer, Skin Cancer, Rectum Cancer
Keywords
Cancer, Cancer Survivors, Immunotherapy, Immune Checkpoint Inhibitors, Symptom Management, Psychosocial Oncology, Telephone Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Intervention
Arm Type
Experimental
Arm Description
The adaptive intervention sequence is assumed to affect psychological distress (depression and anxiety) severity of other symptoms and irAEs, as tested in Aim 1. Both the Automated Telephone Symptom Management (ATSM) system and the Telephone Interpersonal Counseling (TIP-C) interventions help participants to identify and understand troublesome symptoms, with suggestions to effectively self-manage these symptoms. The proposed interventions are expected to alleviate burdensome symptoms through several key mediating variables, as tested in Aim 2.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe. An active control comparator was purposively selected to enable a more rigorous testing of intervention effectiveness in Aims 1 and 2. Also, the study team will be better able to address the question about which channel of communication (automated versus survivor initiated) results in better outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)
Intervention Description
Participants randomized to the adaptive intervention are telephoned weekly and asked to enter by pin-pad or voice the severity of the PRO-CTCAE items on a 0-4 scale, with 0 being none and 4 being very severe. Participants are mailed the Symptom Management and Survivorship Handbook in their preferred language (English or Spanish). Survivors who rated any item at moderate or higher (2-4) will be referred by the ATSM to read the corresponding chapters in the Handbook and given a call back in 24 hours to inquire about the severity of the reported symptom, whether it has improved or worsened, and whether the participant reported it to their HCP, or the HCP has contacted the survivor. Participants that report elevated symptoms for two consecutive weeks are rerandomized to continue the ATSM alone or continue the ATSM with TIP-C added for 8 weeks. TIP-C is delivered by a masters prepared counselor with cancer expertise via weekly 30-minute phone calls using interpersonal techniques.
Intervention Type
Behavioral
Intervention Name(s)
Active control comparator
Intervention Description
Survivors in the active control will receive weekly AVR assessments of PROCTCAE symptoms, and summary of these assessments will be sent securely to HCPs. Survivors will not receive the Handbook and will not be prompted by the AVR to contact HCPs unless the symptoms are severe.
Primary Outcome Measure Information:
Title
Change in patient reported psychological distress in Interviews.
Description
Patient Reported Outcomes Measurement Information System (PROMIS) has been developed using sophisticated measurement techniques, tested with over 21,000 individuals, calibrated to produce t-scores based on the general population and are available in either English or Spanish. The available short forms have evidence of good reliability and validity. PROMIS-short form 8 for depression and anxiety will be administered at baseline and 17-week telephone interviews to provide greater detail and precision in the measurement of severity of these symptoms, as compared to three PRO-CTCAE items (anxious, discouraged, sad). Each question is rated on a five-point scale from 1=Never to 5=Always. A higher score indicates higher anxiety or depression.The study team chose 8-item short forms to minimize respondent burden while maintaining measurement precision.
Time Frame
PROMIS short form 8 for depression and anxiety will be administered at baseline (week 0) and again at week 17 as part of the final follow-up.
Title
Change in reported PRO-CTCAE Symptoms
Description
Psychological distress and other symptoms will be measured weekly using PRO-CTCAE severity items at weeks 0-17. Severity is rated 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The 3 items reflecting psychological distress are anxious, discouraged, and sad. Other items relevant to ICI treatment were selected from the PRO-CTCAE library for a total of 23 items (e.g., nausea, vomiting, constipation, diarrhea, swelling, rash, increased sweating, heart palpitations, etc.). In addition to PRO-CTCAE, the study team will use data on the grades of irAEs documented by clinicians in the HER. Each of 3 item sets, the three PRO-CTCAE items of psychological distress, 23 other PRO-CTCAE items, and clinician documented irAEs will be summarized into three toxicity indices (TIs). All grades of the included items will be ordered from highest to lowest, and the weighted sum will be calculated.
Time Frame
PRO-CTCAE will be administered weekly at baseline (week 0) through week 17.
Secondary Outcome Measure Information:
Title
Change in cancer treatment interruptions
Description
Cancer treatment interruptions (dose reductions and stoppages) along with their dates will be extracted from EHRs and summarized as the number and duration of temporary stoppages and dose reductions, and whether or not a premature permanent or temporary stoppage of the ICI occurred during the 17-week study period.
Time Frame
Cancer treatment interruptions will be measured after the final week 17 follow-up and take into account the participant's time on study (consent date through week 17 interview date).
Title
Change in unscheduled health care visits
Description
Unscheduled health care visits, hospitalizations and emergency department visits will be summarized as the number of events and number of days spent in the hospital if admitted.
Time Frame
Unscheduled health care visits will be measured at baseline and week 17.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Within 12 weeks after starting ICI treatment for cancer Cognitively oriented to person, place and time (determined by recruiter) Able to speak and understand English or Spanish Access to a telephone Severity score of 1 (mild) or higher on at least 1 of the 3 indicators of psychological distress from the PRO-CTCAE (i.e., the three items of anxious, discouraged, sad) library Exclusion Criteria: Currently receiving regular behavioral counseling
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Hadeed
Phone
520-626-0583
Email
mcbarry@arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Badger, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Hadeed
Phone
520-626-0583
Email
mcbarry@arizona.edu
First Name & Middle Initial & Last Name & Degree
UACC IIT
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Terry Badger, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data will be shared with Dr. Alla Sikorski as she is the statistician for our research team and leads data analysis, interpretation of the results, and report writing. Dr. Sikorski will perform quality assurance checks, data analysis, data management, etc. De-identified data will be transferred into SAS 9.4 for such analysis. All errors are corrected during the QA check. Dr. Sikorskii will oversee preparation of data reports.
IPD Sharing Time Frame
Quality assurance and data analysis will be done on a quarterly basis.
IPD Sharing Access Criteria
Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. A data and safety monitoring plan for this study is in place and described under Human Subjects within the protocol.

Learn more about this trial

Adaptive Symptom Self-Management Immunotherapy Study

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