Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers

PRIMARY OBJECTIVES:

I. Evaluate the effect of the intervention, as compared to the control group, on emotional
distress, the primary outcome, measured as anxiety in patients with multiple myeloma and
their caregivers at the transition.

II. Evaluate the effect, including the effect size, of the intervention, as compared to the
control group, on activation for self-management, fatigue, depression, and health-related
quality of life (HRQOL) in both patients and caregivers.

III. Assess the feasibility, acceptability, and content integrity of the intervention in
patients with multiple myeloma and their family caregivers.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants meet with a nurse in-person for approximately 30 minutes to receive
information about strategies for cognitive self-management of distress and an individualized
walking prescription to gradually increase their walking to 30 minutes per day, 5 times per
week. Participants wear a pedometer for at least 3 consecutive days during weeks 1, 6, and
12. Participants are also contacted by the nurse via telephone at 1 and 3 weeks for
supplemental counseling support.

ARM II: Participants meet with a nurse in-person for approximately 20 minutes to receive
National Cancer Institute (NCI) educational booklets and a link to the American Cancer
Society (ACS) website. Participants are also contacted by the nurse via telephone at 1 and 3
weeks but the calls are primarily social in nature and do not include counseling support.

Inclusion Criteria:

- PATIENTS: Within 12 months of a new diagnosis of multiple myeloma or less than or
equal to 2 cycles of treatment (all stages, with or without treatment)

- PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status less than or
equal to 2

- PATIENTS: Ambulatory with or without an assistive device (cane, walker)

- PATIENTS: Cognitively intact, as evidenced by orientation to person, place, and time

- PATIENTS: Ability to speak, read, and comprehend English

- PATIENTS: Has an identified family caregiver who is willing to participate

- CAREGIVERS: Any family member, who is identified by the patient as his/her caregiver

- CAREGIVERS: ECOG performance status less than or equal to 2

- CAREGIVERS: Ambulatory with or without an assistive device (cane, walker)

- CAREGIVERS: Cognitively intact, as evidenced by orientation to person, place, and
time

- CAREGIVERS: Ability to speak, read, and comprehend English

- CAREGIVERS: Has an identified family member who is a patient

- CAREGIVERS: Caregivers do not need to reside with the patient

Exclusion Criteria:

- PATIENTS: Have severe pain (pain score of 7 to 10 on a 0 to 10 scale)

- PATIENTS: Are at high risk for bone fracture or who have a new fracture needing
intervention, as determined by the physician

- PATIENTS: Have untreated venous thrombosis, as determined by the physician

- PATIENTS: Have a life expectancy of less than six months, as determined by the
physician, and their caregivers

- PATIENTS: Receiving active, concurrent treatment for a prior history of cancer
(hormonal therapies allowed)

- CAREGIVERS: Diagnosis of cancer and received cancer treatment within one year

- CAREGIVERS: Medical condition that significantly affects their ability to walk

- PATIENT or CAREGIVER: Is hearing impaired to the degree that they are unable to hear
instructions via the phone

- PATIENTS or CAREGIVER: Lives in a skilled nursing facility