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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129569
• Other study ID #: CASE5A13
• Secondary ID: NCI-2014-00836CA
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: March 16, 2017
• Start date: November 11, 2013
• Est. completion date: August 17, 2016

Study information

• Verified date: March 2017
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 17, 2016
• Est. primary completion date: April 11, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Psychoeducational intervention
Receive information about strategies for cognitive self-management of distress

Behavioral:
• behavioral intervention
Receive individualized walking prescription and wear pedometer

Other:
• counseling intervention
Receive supplemental counseling support over the phone
• educational intervention
Receive NCI educational booklets and a link to the ACS website
• telephone-based intervention
Receive calls that are primarily social in nature
• questionnaire administration
Ancillary studies
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Feasibility of the intervention, assessed via attrition rates		Up to 12 weeks
Secondary	Acceptability of the intervention, assessed via consent rates		Up to 12 weeks
Secondary	Satisfaction with the intervention assessed using an exit interview survey		At 12 weeks
Secondary	Integrity of the intervention, assessed through fidelity monitoring		Up to 12 weeks