Adaptive Symptom Self-Management Immunotherapy Study

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

May 8, 2023

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
Breast CancerColon CancerLung CancerSkin CancerRectum Cancer
Interventions
BEHAVIORAL

Automated Telephone Symptom Management (ATMS) and Telephone Interpersonal Counseling (TIP-C)

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.

BEHAVIORAL

Active control comparator

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.

Trial Locations (3)

48109

RECRUITING

University of Michigan, Ann Arbor

85008

RECRUITING

Valleywise Health Medical Center, Phoenix

85724

RECRUITING

University of Arizona Cancer Center, Tucson

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Arizona

OTHER