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

Not Applicable

Completed

• Conditions: Multiple Myeloma
• Interventions: Other: educational intervention; Other: Psychoeducational intervention; Behavioral: behavioral intervention; Other: telephone-based intervention; Other: counseling intervention; Other: questionnaire administration; Other: quality-of-life assessment

• Registration Number: NCT02129569
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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 Timeline

• Study Start: 2013-11-11
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Primary Completion: 2015-04-11
• Study Completion: 2016-08-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (psychoeducational and behavioral interventions)	behavioral intervention	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 I (psychoeducational and behavioral interventions)	counseling intervention	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 (control)	educational intervention	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.
Arm I (psychoeducational and behavioral interventions)	Psychoeducational intervention	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 I (psychoeducational and behavioral interventions)	questionnaire administration	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 (control)	telephone-based intervention	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.
Arm II (control)	quality-of-life assessment	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.
Arm I (psychoeducational and behavioral interventions)	quality-of-life assessment	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 (control)	questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
Change in emotional distress in patients measured as anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline to up to 12 weeks	A linear mixed model will be used and the model parameters will be estimated by the method of restricted maximum likelihood.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the intervention assessed using an exit interview survey	At 12 weeks
Change in depression in caregivers using the PROMIS	Baseline to up to 12 weeks	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.
Change in fatigue in patients using the PROMIS	Baseline to up to 12 weeks	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.
Change in fatigue in caregivers using the PROMIS	Baseline to up to 12 weeks	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.
Acceptability of the intervention, assessed via consent rates	Up to 12 weeks
Change in activation for self-management in patients using the Patient Activation Measure (PAM)	Baseline to up to 12 weeks	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.
Change in activation for self-management in caregivers using the PAM	Baseline to up to 12 weeks	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.
Change in HRQOL in patients using the PROMIS short form, Global Health	Baseline to up to 12 weeks	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.
Feasibility of the intervention, assessed via attrition rates	Up to 12 weeks
Integrity of the intervention, assessed through fidelity monitoring	Up to 12 weeks
Change in depression in patients using the PROMIS	Baseline to up to 12 weeks	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.
Change in HRQOL in caregivers using the PROMIS short form, Global Health	Baseline to up to 12 weeks	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.

Trial Locations

Locations (1)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States