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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-11

Study Completion Date

2016-08-17

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.

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Psychoeducational intervention

Intervention Type OTHER

Receive information about strategies for cognitive self-management of distress

behavioral intervention

Intervention Type BEHAVIORAL

Receive individualized walking prescription and wear pedometer

counseling intervention

Intervention Type OTHER

Receive supplemental counseling support over the phone

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

educational intervention

Intervention Type OTHER

Receive NCI educational booklets and a link to the ACS website

telephone-based intervention

Intervention Type OTHER

Receive calls that are primarily social in nature

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Psychoeducational intervention

Receive information about strategies for cognitive self-management of distress

Intervention Type OTHER

behavioral intervention

Receive individualized walking prescription and wear pedometer

Intervention Type BEHAVIORAL

counseling intervention

Receive supplemental counseling support over the phone

Intervention Type OTHER

educational intervention

Receive NCI educational booklets and a link to the ACS website

Intervention Type OTHER

telephone-based intervention

Receive calls that are primarily social in nature

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Therapy Behavioral Modification Behavioral Therapy Behavioral Treatment counseling and communications studies intervention, educational quality of life assessment

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes