This trial studies post-chemotherapy symptom management intervention for cancer survivors with solid tumors that have come back at or near the same place as the original (primary) tumor (locally recurrent). This study aims to learn if either of the two therapies, a printed Symptom Management and Survivorship Handbook or Telephone Education and Counseling Intervention may help cancer survivors feel better physically and/or emotionally following cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03494166.
PRIMARY OBJECTIVES:
I. Test the effects of interventions on summed index of severity of 15 post-chemotherapy symptoms (primary outcome) and symptom-specific responses and times to response (secondary outcomes).
II. Compare symptom outcomes of intervention sequences against the benchmark low need group.
EXPLORATORY OBJECTIVE:
I. Explore which survivor characteristics are associated with responses to the Symptom Management and Survivorship Guide (SMSG) alone during weeks 1-4 and optimal symptom outcomes during weeks 1-13.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive SMSG for 4 weeks. Patients who respond on depression continuous to receive another 8 weeks of SMSG alone. Patients who do not respond on depression are randomized to either continuous to receive another 8 weeks of SMSG alone, or another 8 weeks of SMSG and weekly Telephone Interpersonal Counselling (TIP-C) sessions over 30 minutes each.
ARM II: Patients receive SMSG and weekly TIP-C sessions over 30 minutes each for 8 weeks followed by SMSG alone for 4 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorTerry A. Badger
