Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer

Summary: RATIONALE: Telephone counseling by trained counselors may enhance the well-being and quality of life of patients who have undergone stem cell transplantation for cancer.
  PURPOSE: Randomized clinical trial to compare the effectiveness of standard follow-up care with extended follow-up care in treating patients who have undergone stem cell transplantation for cancer.

Detailed description: OBJECTIVES:
  -  Compare the recovery course of patients with malignancies who undergo standard vs extended recovery preparation after hematopoietic stem cell transplantation.
  -  Compare the efficacy of these recovery preparations in managing rehabilitation needs, including reduced stamina and cognitive limitations, of these patients.
  -  Compare the ability of these recovery preparations to assist patients and caregivers in adjusting to unavoidable fluctuations in caregiver roles and emotions.
  -  Compare the ability of these recovery preparations to assist female patients in managing menopausal symptoms and sexual function changes.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender, type of transplantation (allogeneic vs autologous), ethnicity (Caucasian vs non-Caucasian), total body irradiation (yes vs no), and participating center. Patients are randomized to 1 of 2 supportive care arms.
  Patients complete 1 baseline assessment prior to transplant and a second assessment after the transplant, approximately 1 week before returning home.
  -  Arm I (Standard Recovery Preparation): Patients and caregivers receive standard preparation prior to discharge, a booklet of stem cell transplant-related resources and contact information, and the National Cancer Institute-produced publication entitled "Facing Forward".
  -  Arm II (Recovery Preparation Intervention): Patients and caregivers receive standard preparation and resource materials as in arm I. Women also receive 10 scheduled telephone appointment sessions, lasting 1 hour each, over the first year after returning home. Men receive 9 scheduled telephone appointment sessions in the same manner as the women. The first 5-6 sessions have a specific topic with a corresponding video. The last 4 calls are booster calls to answer questions, identify new problems, and provide support. Patients with acute problems or problems that cannot be handled through regular sessions are referred to the interdisciplinary recovery triage team. Problems addressed by this team include depression, agitation, cognitive change, fatigue, family disruptions, sexuality, and gynecologic or menopausal difficulties.
  Patients are followed at 1 and 2 years.
  PROJECTED ACCRUAL: A total of 412 patients and their caregivers (385 patients randomized) will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of a malignancy
  -  Planned bone marrow, stem cell, or umbilical cord transplantation after a myeloablative conditioning regimen
  -  Must have completed radiotherapy and conditioning chemotherapy
  -  Must be first stem cell transplantation
  -  Must recover sufficiently, physically and cognitively, to be ambulatory and able to live at home
  -  Must be planning to live with primary caregiver for at least 3 months upon return home
  -  No refractory breast cancer requiring treatment on a phase I protocol
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Must be able to read, write, and communicate well by phone in English
  -  Must not be deaf or blind
  -  Must live in the United States
  -  Must not be too ill or in too much pain
  -  No major psychiatric disorders not in remission
  -  No prisoners
  -  No prior major alcohol or drug abuse
  -  No major cognitive problems
  -  No other concurrent confounding major illness
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  See Disease Characteristics
  Chemotherapy
  -  See Disease Characteristics
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  See Disease Characteristics
  Surgery
  -  Not specified

Relevance to patient case: not relevant