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

Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: questionnaire administration; Other: quality-of-life assessment; Other: Psychoeducational intervention; Behavioral: behavioral intervention; Other: counseling intervention; Other: educational intervention; Other: telephone-based intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I (psychoeducational and behavioral interventions); 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: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: Psychoeducational intervention; Receive information about strategies for cognitive self-management of distress; Behavioral: behavioral intervention; Receive individualized walking prescription and wear pedometer; Other Names: Behavior Conditioning Therapy; Behavior Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Other: counseling intervention; Receive supplemental counseling support over the phone; Other Names: counseling and communications studies
ACTIVE_COMPARATOR: Arm II (control); 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: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: educational intervention; Receive NCI educational booklets and a link to the ACS website; Other Names: intervention, educational; Other: telephone-based intervention; Receive calls that are primarily social in nature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in activation for self-management in patients using the Patient Activation Measure (PAM)	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in activation for self-management in caregivers using the PAM	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in fatigue in patients using the PROMIS	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in fatigue in caregivers using the PROMIS	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in depression in patients using the PROMIS	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in depression in caregivers using the PROMIS	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in HRQOL in patients using the PROMIS short form, Global Health	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Change in HRQOL in caregivers using the PROMIS short form, Global Health	A linear mixed model will be used. If there are large numbers of missing values, the parameters will be estimated by utilizing the "pattern mixture model." Should the change be non-linear, the model may be extended to allow for non-linearity. In the case of parametric model assumption violation, the generalized estimating equation approach may be used.	Baseline to up to 12 weeks
Feasibility of the intervention, assessed via attrition rates		Up to 12 weeks
Acceptability of the intervention, assessed via consent rates		Up to 12 weeks
Satisfaction with the intervention assessed using an exit interview survey		At 12 weeks
Integrity of the intervention, assessed through fidelity monitoring		Up to 12 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Susan Mazanec, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2013
• Primary Completion (ACTUAL): April 11, 2015
• Study Completion (ACTUAL): August 17, 2016

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (ESTIMATE): May 2, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CASE5A13; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00836 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CASE 5A13 (OTHER: Case Comprehensive Cancer Center)