Clinical trial · Interventional
Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers
Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
NCT02129569CI-TRIAL-00026522completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| behavioral intervention | Behavioral | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| Psychoeducational intervention | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| telephone-based intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (psychoeducational and behavioral interventions)
- 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.
- interventionNames
- Other: Psychoeducational intervention
- Behavioral: behavioral intervention
- Other: counseling intervention
- Other: questionnaire administration
- Other: quality-of-life assessment
- type
- ACTIVE_COMPARATOR
- label
- Arm II (control)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.