Chronic Leukemia, Hematopoietic and Lymphoid System Neoplasm, Lymphoma, Malignant Solid Neoplasm, Multiple Myeloma
Conditions
Brief summary
This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. Cancer pain is prevalent, under treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at double risk for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.
Detailed description
PRIMARY OBJECTIVE: I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors. GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study. GROUP II: ASCENT study interventionists complete an interview on study. GROUP III: Medical oncology providers participate in a focus group on study.
Interventions
OTHERExercise
Participate in exercise
OTHERInterview
Complete interview
PROCEDUREMassage Therapy
Receive massage
BEHAVIORALMindfulness Relaxation
Practice mindfulness
PROCEDUREAcupuncture Therapy
Undergo acupuncture therapy
BEHAVIORALCancer Pain Management
Receive pain clinic referral
BEHAVIORALCognitive Behavior Therapy
Undergo CBT
PROCEDUREDiscussion
Participate in focus group
OTHEREducational Intervention
Receive self-guided pain management education materials
PROCEDUREPain Therapy
Receive pain treatment/medicine
OTHERPalliative Therapy
Receive palliative care referral
BEHAVIORALPatient Navigation
Undergo visits with PCM and CHW for pain management
OTHERReferral
Receive pain management referrals
PROCEDURESpiritual Therapy
Receive spiritual support
PROCEDURESpiritual Care Referral
Receive spiritual care referral
OTHERSurvey Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A qualifying liquid or solid cancer diagnosis with visits at a participating Mayo site * Age 18+ * Numerical rating scale (NRS) pain score of a 5+ out of 10 * Pain that developed (onset) or significantly worsened since cancer diagnosis * Malignant hematology including: * Lymphoma * Myeloma * Chronic leukemias
Exclusion criteria
* Patient Health Questionnaire (PHQ) 8 score of 10 or more * Life expectancy less than 12 months * Hospice enrollment * Admitted to hospital from long term care/skilled nursing facilities (SNF) * Acute leukemias * Primary brain tumors * Confinement to a bed or a chair more than a third of waking hours because of health complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention | Up to 60 days | Assessed by proportion of participants who received key intervention components. |
| Acceptability of Intervention - Interaction | Up to 60 days | As assessed by frequency of participant interaction with care team. |
| Acceptability of Intervention - Satisfaction | Up to 60 days | As assessed by participant satisfaction with care team interactions |
| Utility of Intervention - Helpfulness | Up to 60 days | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful. |
| Utility of Intervention - Confidence | Up to 60 days | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident. |
| Utility of Intervention - Ease | Up to 60 days | Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy. |
Countries
United States
Participant flow
Pre-assignment details
Only Group 1 were actual participants who were enrolled in the study and received the intervention. Data was only collected for Group 1, so this is the only data reported. Group 2 consisted of interventionalists (provided the intervention to Group 1 participants). Group 3 were Medical Oncology providers. Neither Group 2 nor 3 received any intervention or were enrolled in the study. Groups 2 and 3 participated only in study development.
Participants by arm
| Arm | Count |
|---|---|
| Group I (Pain Management) See detailed description.
Acupuncture Therapy: Undergo acupuncture therapy
Cancer Pain Management: Receive pain clinic referral
Cognitive Behavior Therapy: Undergo CBT
Educational Intervention: Receive self-guided pain management education materials
Exercise: Participate in exercise
Interview: Complete interview
Massage Therapy: Receive massage
Mindfulness Relaxation: Practice mindfulness
Pain Therapy: Receive pain treatment/medicine
Palliative Therapy: Receive palliative care referral
Patient Navigation: Undergo visits with PCM and CHW for pain management
Referral: Receive pain management referrals
Spiritual Therapy: Receive spiritual support
Spiritual Care Referral: Receive spiritual care referral
Survey Administration: Ancillary studies | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Group I (Pain Management) |
|---|---|
| Age, Continuous | 62.03922 years STANDARD_DEVIATION 12.69167 |
| Cancer type Breast | 13 Participants |
| Cancer type Endocrine | 2 Participants |
| Cancer type Genitourinary | 4 Participants |
| Cancer type GI | 7 Participants |
| Cancer type GYN | 1 Participants |
| Cancer type Head and neck | 2 Participants |
| Cancer type Heme | 9 Participants |
| Cancer type Lung | 5 Participants |
| Cancer type Melanoma | 2 Participants |
| Cancer type Other | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 51 participants |
| Rural-Urban Commuting Area (RUCA) category Large rural (RUCA 4-6) | 1 Participants |
| Rural-Urban Commuting Area (RUCA) category Rural (RUCA 10) | 29 Participants |
| Rural-Urban Commuting Area (RUCA) category Small rural (RUCA 7-9) | 3 Participants |
| Rural-Urban Commuting Area (RUCA) category Urban (RUCA 1-3) | 18 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 51 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 51 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Acceptability of Intervention - Interaction
As assessed by frequency of participant interaction with care team.
Time frame: Up to 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Pain Management) | Acceptability of Intervention - Interaction | Never | 0 Participants |
| Group I (Pain Management) | Acceptability of Intervention - Interaction | Once | 1 Participants |
| Group I (Pain Management) | Acceptability of Intervention - Interaction | Every other week | 18 Participants |
| Group I (Pain Management) | Acceptability of Intervention - Interaction | Weekly | 16 Participants |
| Group I (Pain Management) | Acceptability of Intervention - Interaction | Multiple times a week | 0 Participants |
Primary
Acceptability of Intervention - Satisfaction
As assessed by participant satisfaction with care team interactions
Time frame: Up to 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Pain Management) | Acceptability of Intervention - Satisfaction | Not satisfied with frequency of communication with a member of the ASCENT care team | 0 Participants |
| Group I (Pain Management) | Acceptability of Intervention - Satisfaction | Satisfied with frequency of communication with a member of the ASCENT care team | 35 Participants |
Primary
Feasibility of Intervention
Assessed by proportion of participants who received key intervention components.
Time frame: Up to 60 days
Population: Participants who completed all three visits were sent a survey about their experience with the ASCENT pilot--of the 41 who completed all 3 visits, 35 completed the survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group I (Pain Management) | Feasibility of Intervention | Completed intake visit, planning visit, and final visit | 41 Participants |
| Group I (Pain Management) | Feasibility of Intervention | Utilized materials sent to the portal | 17 Participants |
| Group I (Pain Management) | Feasibility of Intervention | Utilized mailed materials that discussed pain management techniques | 11 Participants |
| Group I (Pain Management) | Feasibility of Intervention | Utilized ASCENT website | 5 Participants |
| Group I (Pain Management) | Feasibility of Intervention | Utilized follow-up phone calls with a member of the ASCENT team | 27 Participants |
| Group I (Pain Management) | Feasibility of Intervention | Utilized the Action Plan | 16 Participants |
Primary
Utility of Intervention - Confidence
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all confident and 5 = extremely confident.
Time frame: Up to 60 days
Population: Five patients did not set goals and thus the question about setting goals with the care team was not applicable.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | Not at all confident | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | Somewhat confident | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | Confident | 6 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | Very confident | 10 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | Extremely confident | 9 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan | N/A | 5 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | Not at all confident | 6 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | Somewhat confident | 7 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | Confident | 6 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | Very confident | 13 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | Extremely confident | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in ability to find resources to help with pain | N/A | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | Not at all confident | 5 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | Somewhat confident | 9 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | Confident | 5 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | Very confident | 13 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | Extremely confident | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Confidence | Confidence in managing pain better in the future | N/A | 0 Participants |
Primary
Utility of Intervention - Ease
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
Time frame: Up to 60 days
Population: Participants were asked about the ease of use of specific components of the ASCENT intervention if and only if they utilized these components. Five participants did not utilize these components.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the ASCENT website | Very easy | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the Action Plan | Somewhat difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the Action Plan | Neither easy nor difficult | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding materials sent to the patient portal | Very difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding materials sent to the patient portal | Somewhat difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding materials sent to the patient portal | Neither easy nor difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding materials sent to the patient portal | Somewhat easy | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding materials sent to the patient portal | Very easy | 15 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding mailed materials that discussed pain management techniques | Very difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding mailed materials that discussed pain management techniques | Somewhat difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding mailed materials that discussed pain management techniques | Neither easy nor difficult | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding mailed materials that discussed pain management techniques | Somewhat easy | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding mailed materials that discussed pain management techniques | Very easy | 8 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the ASCENT website | Very difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the ASCENT website | Somewhat difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the ASCENT website | Neither easy nor difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the ASCENT website | Somewhat easy | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding follow-up phone calls with a member of the ASCENT team | Very difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding follow-up phone calls with a member of the ASCENT team | Somewhat difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding follow-up phone calls with a member of the ASCENT team | Neither easy nor difficult | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding follow-up phone calls with a member of the ASCENT team | Somewhat easy | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding follow-up phone calls with a member of the ASCENT team | Very easy | 24 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the Action Plan | Very difficult | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the Action Plan | Somewhat easy | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Ease | Ease of understanding the Action Plan | Very easy | 15 Participants |
Primary
Utility of Intervention - Helpfulness
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
Time frame: Up to 60 days
Population: Participants were asked about the helpfulness of specific components of the ASCENT intervention if and only if they utilized that component.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of working with the ASCENT care team | Not at all helpful | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of working with the ASCENT care team | Somewhat helpful | 7 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of working with the ASCENT care team | Helpful | 6 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of working with the ASCENT care team | Very helpful | 9 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of working with the ASCENT care team | Extremely helpful | 11 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the materials sent to the patient portal | Not at all helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the materials sent to the patient portal | Somewhat helpful | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the materials sent to the patient portal | Helpful | 4 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the materials sent to the patient portal | Very helpful | 8 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the materials sent to the patient portal | Extremely helpful | 4 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the mailed materials that discussed different pain management techniques | Not at all helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the mailed materials that discussed different pain management techniques | Somewhat helpful | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the mailed materials that discussed different pain management techniques | Helpful | 4 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the mailed materials that discussed different pain management techniques | Very helpful | 5 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the mailed materials that discussed different pain management techniques | Extremely helpful | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the ASCENT website | Not at all helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the ASCENT website | Somewhat helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the ASCENT website | Helpful | 2 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the ASCENT website | Very helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the ASCENT website | Extremely helpful | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the follow-up phone calls with a member of the ASCENT team | Not at all helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the follow-up phone calls with a member of the ASCENT team | Somewhat helpful | 4 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the follow-up phone calls with a member of the ASCENT team | Helpful | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the follow-up phone calls with a member of the ASCENT team | Very helpful | 11 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the follow-up phone calls with a member of the ASCENT team | Extremely helpful | 9 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the Action Plan | Not at all helpful | 0 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the Action Plan | Somewhat helpful | 1 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the Action Plan | Helpful | 3 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the Action Plan | Very helpful | 4 Participants |
| Group I (Pain Management) | Utility of Intervention - Helpfulness | Helpfulness of the Action Plan | Extremely helpful | 8 Participants |