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

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ClinicalTrials.gov Identifier: NCT02129569
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Psychoeducational intervention Behavioral: behavioral intervention Other: counseling intervention Other: educational intervention Other: telephone-based intervention Other: questionnaire administration Other: quality-of-life assessment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
Actual Study Start Date : November 11, 2013
Actual Primary Completion Date : April 11, 2015
Actual Study Completion Date : August 17, 2016

Resource links provided by the National Library of Medicine


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: 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 Name: counseling and communications studies

Other: questionnaire administration
Ancillary studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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: educational intervention
Receive NCI educational booklets and a link to the ACS website
Other Name: intervention, educational

Other: telephone-based intervention
Receive calls that are primarily social in nature

Other: questionnaire administration
Ancillary studies

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment




Primary Outcome Measures :
  1. Change in emotional distress in patients measured as anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 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 :
  1. Change in activation for self-management in patients using the Patient Activation Measure (PAM) [ Time Frame: 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.

  2. Change in activation for self-management in caregivers using the PAM [ Time Frame: 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.

  3. Change in fatigue in patients using the PROMIS [ Time Frame: 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.

  4. Change in fatigue in caregivers using the PROMIS [ Time Frame: 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.

  5. Change in depression in patients using the PROMIS [ Time Frame: 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.

  6. Change in depression in caregivers using the PROMIS [ Time Frame: 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.

  7. Change in HRQOL in patients using the PROMIS short form, Global Health [ Time Frame: 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.

  8. Change in HRQOL in caregivers using the PROMIS short form, Global Health [ Time Frame: 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.

  9. Feasibility of the intervention, assessed via attrition rates [ Time Frame: Up to 12 weeks ]
  10. Acceptability of the intervention, assessed via consent rates [ Time Frame: Up to 12 weeks ]
  11. Satisfaction with the intervention assessed using an exit interview survey [ Time Frame: At 12 weeks ]
  12. Integrity of the intervention, assessed through fidelity monitoring [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129569


Locations
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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susan Mazanec Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02129569     History of Changes
Other Study ID Numbers: CASE5A13
NCI-2014-00836 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 5A13 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases