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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational intervention
behavioral intervention
counseling intervention
educational intervention
telephone-based intervention
questionnaire administration
quality-of-life assessment
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (psychoeducational and behavioral interventions)

Arm II (control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Feasibility of the intervention, assessed via attrition rates
Acceptability of the intervention, assessed via consent rates
Satisfaction with the intervention assessed using an exit interview survey
Integrity of the intervention, assessed through fidelity monitoring

Full Information

First Posted
April 30, 2014
Last Updated
March 16, 2017
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02129569
Brief Title
Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers
Official Title
Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
April 11, 2015 (Actual)
Study Completion Date
August 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (psychoeducational and behavioral interventions)
Arm Type
Experimental
Arm Description
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 Title
Arm II (control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducational intervention
Intervention Description
Receive information about strategies for cognitive self-management of distress
Intervention Type
Behavioral
Intervention Name(s)
behavioral intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy, Behavioral Treatment
Intervention Description
Receive individualized walking prescription and wear pedometer
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Receive supplemental counseling support over the phone
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive NCI educational booklets and a link to the ACS website
Intervention Type
Other
Intervention Name(s)
telephone-based intervention
Intervention Description
Receive calls that are primarily social in nature
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in emotional distress in patients measured as anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
A linear mixed model will be used and the model parameters will be estimated by the method of restricted maximum likelihood.
Time Frame
Baseline to up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in activation for self-management in patients using the Patient Activation Measure (PAM)
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in activation for self-management in caregivers using the PAM
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in fatigue in patients using the PROMIS
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in fatigue in caregivers using the PROMIS
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in depression in patients using the PROMIS
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in depression in caregivers using the PROMIS
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in HRQOL in patients using the PROMIS short form, Global Health
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Change in HRQOL in caregivers using the PROMIS short form, Global Health
Description
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.
Time Frame
Baseline to up to 12 weeks
Title
Feasibility of the intervention, assessed via attrition rates
Time Frame
Up to 12 weeks
Title
Acceptability of the intervention, assessed via consent rates
Time Frame
Up to 12 weeks
Title
Satisfaction with the intervention assessed using an exit interview survey
Time Frame
At 12 weeks
Title
Integrity of the intervention, assessed through fidelity monitoring
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Mazanec
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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