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

NCT02129569 | Completed DMC

• 4 other identifiers: CASE5A13NCI-2014-00836CASE 5A13P30CA043703
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Change in emotional distress in patients measured as anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS)

  A linear mixed model will be used and the model parameters will be estimated by the method of restricted maximum likelihood.

  Baseline to up to 12 weeks

Secondary Outcomes (12)

• Change in activation for self-management in patients using the Patient Activation Measure (PAM)

  Baseline to up to 12 weeks

• Change in activation for self-management in caregivers using the PAM

  Baseline to up to 12 weeks

• Change in fatigue in patients using the PROMIS

  Baseline to up to 12 weeks

• Change in fatigue in caregivers using the PROMIS

  Baseline to up to 12 weeks

• Change in depression in patients using the PROMIS

  Baseline to up to 12 weeks

Study Arms (2)

Arm I (psychoeducational and behavioral interventions)

EXPERIMENTAL

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.

Other: Psychoeducational intervention; Behavioral: behavioral intervention; Other: counseling intervention; Other: questionnaire administration; Other: quality-of-life assessment

Arm II (control)

ACTIVE COMPARATOR

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.

Other: educational intervention; Other: telephone-based intervention; Other: questionnaire administration; Other: quality-of-life assessment

Interventions

Psychoeducational intervention OTHER

Receive information about strategies for cognitive self-management of distress

Arm I (psychoeducational and behavioral interventions)

behavioral intervention BEHAVIORAL

Receive individualized walking prescription and wear pedometer

Also known as: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment

Arm I (psychoeducational and behavioral interventions)

counseling intervention OTHER

Receive supplemental counseling support over the phone

Also known as: counseling and communications studies

Arm I (psychoeducational and behavioral interventions)

educational intervention OTHER

Receive NCI educational booklets and a link to the ACS website

Also known as: intervention, educational

Arm II (control)

telephone-based intervention OTHER

Receive calls that are primarily social in nature

Arm II (control)

questionnaire administration OTHER

Ancillary studies

Arm I (psychoeducational and behavioral interventions); Arm II (control)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Arm I (psychoeducational and behavioral interventions); Arm II (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Behavior Therapy; Counseling; Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Investigative Techniques

Study Officials

• Susan Mazanec

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: November 11, 2013
• Primary Completion: April 11, 2015
• Study Completion: August 17, 2016
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)