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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Multiple Myeloma

Treatments: Other: counseling intervention; Other: educational intervention; Other: telephone-based intervention; Behavioral: behavioral intervention; Other: Psychoeducational intervention; Other: questionnaire administration; Other: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02129569

CASE 5A13 (Other Identifier)

NCI-2014-00836 (Registry Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE5A13

Details and patient eligibility

About

This pilot clinical trial studies how well psychoeducational and behavioral strategies work in reducing distress and anxiety in patients with multiple myeloma and their family caregivers. Education and walking programs, may be able to reduce distress and anxiety and improve the well-being and quality of life of patients with multiple myeloma and their family caregivers. Understanding how different forms of education and support can promote emotional wellness may help nurse researchers find ways to improve services provided to patients and family members during cancer treatment.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Arm I (psychoeducational and behavioral interventions)

Experimental group

Description:

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.

Treatment:

Other: quality-of-life assessment

Other: questionnaire administration

Other: Psychoeducational intervention

Behavioral: behavioral intervention

Other: counseling intervention

Arm II (control)

Active Comparator group

Description:

Participants meet with a nurse in-person for approximately 20 minutes to receive NCI educational booklets and a link to the 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.

Treatment:

Other: quality-of-life assessment

Other: questionnaire administration

Other: educational intervention

Other: telephone-based intervention