Multiple MyelomaNCT02129569
Psychoeducational and Behavioral Strategies in Reducing Distress and Anxiety in Patients With Multiple Myeloma and Their Family Caregivers
A study testing Psychoeducational intervention, behavioral intervention and counseling intervention in people with Multiple Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Psychoeducational intervention, behavioral intervention and counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2013to 17 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Multiple Myeloma
- Being tested
- Psychoeducational intervention, behavioral intervention, counseling intervention, educational intervention, telephone-based intervention
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational interventionOther
Receive information about strategies for cognitive self-management of distress
behavioral interventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral Therapy
Receive individualized walking prescription and wear pedometer
counseling interventionOther
Also called counseling and communications studies
Receive supplemental counseling support over the phone
educational interventionOther
Also called intervention, educational
Receive NCI educational booklets and a link to the ACS website
telephone-based interventionOther
Receive calls that are primarily social in nature
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (psychoeducational and behavioral interventions) | Experimental | 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. Receives: Other: Psychoeducational intervention; Behavioral: behavioral intervention; Other: counseling intervention; Other: questionnaire administration; Other: quality-of-life assessment |
| Arm II (control) | Active comparator | 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. Receives: Other: educational intervention; Other: telephone-based intervention; Other: questionnaire administration; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 12 weeks
Secondary outcomes (12)
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
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.
Measured: Baseline to up to 12 weeks
Feasibility of the intervention, assessed via attrition rates
Measured: Up to 12 weeks
Acceptability of the intervention, assessed via consent rates
Measured: Up to 12 weeks
Satisfaction with the intervention assessed using an exit interview survey
Measured: At 12 weeks
Integrity of the intervention, assessed through fidelity monitoring
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start11 Nov 2013
- Primary completion11 Apr 2015
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Susan Mazanec, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129569
- Sponsor's protocol ID
- CASE5A13
- Other IDs
- NCI-2014-00836, CASE 5A13, P30CA043703
- Status last verified
- Mar 2017
- First submitted
- 30 Apr 2014
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Intervention for the Transition to Living With Multiple Myeloma as a Chronic Illness
- ClinicalTrials.gov ID
- NCT02129569
- Acronym / sponsor ID
- CASE5A13
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 11 Apr 2015 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (psychoeducational and behavioral interventions) | Experimental | Other: Psychoeducational intervention, Behavioral: behavioral intervention, Other: counseling intervention, Other: questionnaire administration, Other: quality-of-life assessmentParticipants 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 (control) | Active comparator | Other: educational intervention, Other: telephone-based intervention, Other: questionnaire administration, Other: quality-of-life assessmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational interventionReceive information about strategies for cognitive self-management of distress | Other | Arm I (psychoeducational and behavioral interventions) |
| behavioral interventionAlso: Behavior Conditioning Therapy, Behavior Therapy, Behavioral Modification, Behavioral TherapyReceive individualized walking prescription and wear pedometer | Behavioural | Arm I (psychoeducational and behavioral interventions) |
| counseling interventionAlso: counseling and communications studiesReceive supplemental counseling support over the phone | Other | Arm I (psychoeducational and behavioral interventions) |
| educational interventionAlso: intervention, educationalReceive NCI educational booklets and a link to the ACS website | Other | Arm II (control) |
| telephone-based interventionReceive calls that are primarily social in nature | Other | Arm II (control) |
| questionnaire administrationAncillary studies | Other | Arm I (psychoeducational and behavioral interventions), Arm II (control) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (psychoeducational and behavioral interventions), Arm II (control) |
Primary outcome
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.
12 secondary outcomes
Change in activation for self-management in patients using the Patient Activation Measure (PAM)
Time frame: Baseline to up to 12 weeks
Change in activation for self-management in caregivers using the PAM
Time frame: Baseline to up to 12 weeks
Change in fatigue in patients using the PROMIS
Time frame: Baseline to up to 12 weeks
Change in fatigue in caregivers using the PROMIS
Time frame: Baseline to up to 12 weeks
Change in depression in patients using the PROMIS
Time frame: Baseline to up to 12 weeks
Change in depression in caregivers using the PROMIS
Time frame: Baseline to up to 12 weeks
Change in HRQOL in patients using the PROMIS short form, Global Health
Time frame: Baseline to up to 12 weeks
Change in HRQOL in caregivers using the PROMIS short form, Global Health
Time frame: Baseline to up to 12 weeks
Feasibility of the intervention, assessed via attrition rates
Time frame: Up to 12 weeks
Acceptability of the intervention, assessed via consent rates
Time frame: Up to 12 weeks
Satisfaction with the intervention assessed using an exit interview survey
Time frame: At 12 weeks
Integrity of the intervention, assessed through fidelity monitoring
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Mazanec principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention, behavioral intervention and counseling intervention in people with Multiple Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.