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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Psychoeducational intervention
* Behavioral: behavioral intervention
* Other: counseling intervention
* Other: educational intervention
* Other: telephone-based intervention
* Other: questionnaire administration
* Other: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |