Trial Outcomes & Findings for Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study (NCT NCT06063603)
NCT ID: NCT06063603
Last Updated: 2025-09-18
Results Overview
Assessed by proportion of participants who received key intervention components.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Up to 60 days
Results posted on
2025-09-18
Participant Flow
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.
Participant milestones
| Measure |
Group I (Pain Management)
See detailed description.
Acupuncture Therapy: Undergo acupuncture therapy
Cancer Pain Management: Receive pain clinic referral
Cognitive Behavior Therapy(CBT): 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 pain care manager (PCM) and community health worker (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
|
Group 2 (Intervention Providers)
Study interventionalists complete an interview on study.
|
Group 3 (Medical Oncology Providers)
Medical oncology providers participate in a focus group on study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
5
|
3
|
|
Overall Study
Completed Intake Visit
|
44
|
0
|
0
|
|
Overall Study
Completed Planning Visit
|
43
|
0
|
0
|
|
Overall Study
Completed Final Visit
|
41
|
0
|
0
|
|
Overall Study
Completed Survey
|
35
|
0
|
0
|
|
Overall Study
Participated in Focus Group
|
0
|
0
|
3
|
|
Overall Study
Participated in Interventionalist's Interview
|
0
|
5
|
0
|
|
Overall Study
COMPLETED
|
35
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
16
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study
Baseline characteristics by cohort
| Measure |
Group I (Pain Management)
n=51 Participants
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
|
|---|---|
|
Age, Continuous
|
62.03922 years
STANDARD_DEVIATION 12.69167 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) category
Urban (RUCA 1-3)
|
18 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) category
Large rural (RUCA 4-6)
|
1 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) category
Small rural (RUCA 7-9)
|
3 Participants
n=5 Participants
|
|
Rural-Urban Commuting Area (RUCA) category
Rural (RUCA 10)
|
29 Participants
n=5 Participants
|
|
Cancer type
Breast
|
13 Participants
n=5 Participants
|
|
Cancer type
Endocrine
|
2 Participants
n=5 Participants
|
|
Cancer type
GI
|
7 Participants
n=5 Participants
|
|
Cancer type
GYN
|
1 Participants
n=5 Participants
|
|
Cancer type
Genitourinary
|
4 Participants
n=5 Participants
|
|
Cancer type
Head and neck
|
2 Participants
n=5 Participants
|
|
Cancer type
Heme
|
9 Participants
n=5 Participants
|
|
Cancer type
Lung
|
5 Participants
n=5 Participants
|
|
Cancer type
Melanoma
|
2 Participants
n=5 Participants
|
|
Cancer type
Other
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysPopulation: 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.
Assessed by proportion of participants who received key intervention components.
Outcome measures
| Measure |
Group I (Pain Management)
n=51 Participants
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
|
|---|---|
|
Feasibility of Intervention
Completed intake visit, planning visit, and final visit
|
41 Participants
|
|
Feasibility of Intervention
Utilized materials sent to the portal
|
17 Participants
|
|
Feasibility of Intervention
Utilized mailed materials that discussed pain management techniques
|
11 Participants
|
|
Feasibility of Intervention
Utilized ASCENT website
|
5 Participants
|
|
Feasibility of Intervention
Utilized follow-up phone calls with a member of the ASCENT team
|
27 Participants
|
|
Feasibility of Intervention
Utilized the Action Plan
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysAs assessed by frequency of participant interaction with care team.
Outcome measures
| Measure |
Group I (Pain Management)
n=35 Participants
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
|
|---|---|
|
Acceptability of Intervention - Interaction
Never
|
0 Participants
|
|
Acceptability of Intervention - Interaction
Once
|
1 Participants
|
|
Acceptability of Intervention - Interaction
Every other week
|
18 Participants
|
|
Acceptability of Intervention - Interaction
Weekly
|
16 Participants
|
|
Acceptability of Intervention - Interaction
Multiple times a week
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysAs assessed by participant satisfaction with care team interactions
Outcome measures
| Measure |
Group I (Pain Management)
n=35 Participants
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
|
|---|---|
|
Acceptability of Intervention - Satisfaction
Not satisfied with frequency of communication with a member of the ASCENT care team
|
0 Participants
|
|
Acceptability of Intervention - Satisfaction
Satisfied with frequency of communication with a member of the ASCENT care team
|
35 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysPopulation: Participants were asked about the helpfulness of specific components of the ASCENT intervention if and only if they utilized that component.
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = not at all and 5 = extremely helpful.
Outcome measures
| Measure |
Group I (Pain Management)
n=35 Participants
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
|
|---|---|
|
Utility of Intervention - Helpfulness
Helpfulness of working with the ASCENT care team · Not at all helpful
|
2 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of working with the ASCENT care team · Somewhat helpful
|
7 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of working with the ASCENT care team · Helpful
|
6 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of working with the ASCENT care team · Very helpful
|
9 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of working with the ASCENT care team · Extremely helpful
|
11 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the materials sent to the patient portal · Not at all helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the materials sent to the patient portal · Somewhat helpful
|
1 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the materials sent to the patient portal · Helpful
|
4 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the materials sent to the patient portal · Very helpful
|
8 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the materials sent to the patient portal · Extremely helpful
|
4 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the mailed materials that discussed different pain management techniques · Not at all helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the mailed materials that discussed different pain management techniques · Somewhat helpful
|
1 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the mailed materials that discussed different pain management techniques · Helpful
|
4 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the mailed materials that discussed different pain management techniques · Very helpful
|
5 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the mailed materials that discussed different pain management techniques · Extremely helpful
|
1 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the ASCENT website · Not at all helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the ASCENT website · Somewhat helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the ASCENT website · Helpful
|
2 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the ASCENT website · Very helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the ASCENT website · Extremely helpful
|
3 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the follow-up phone calls with a member of the ASCENT team · Not at all helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the follow-up phone calls with a member of the ASCENT team · Somewhat helpful
|
4 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the follow-up phone calls with a member of the ASCENT team · Helpful
|
3 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the follow-up phone calls with a member of the ASCENT team · Very helpful
|
11 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the follow-up phone calls with a member of the ASCENT team · Extremely helpful
|
9 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the Action Plan · Not at all helpful
|
0 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the Action Plan · Somewhat helpful
|
1 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the Action Plan · Helpful
|
3 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the Action Plan · Very helpful
|
4 Participants
|
|
Utility of Intervention - Helpfulness
Helpfulness of the Action Plan · Extremely helpful
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysPopulation: Five patients did not set goals and thus the question about setting goals with the care team was not applicable.
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.
Outcome measures
| Measure |
Group I (Pain Management)
n=35 Participants
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
|
|---|---|
|
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
|
|
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
|
|
Utility of Intervention - Confidence
Confidence in achieving goal(s) set with the ASCENT care team as part of the action plan · Confident
|
6 Participants
|
|
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
|
|
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
|
|
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
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · Not at all confident
|
6 Participants
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · Somewhat confident
|
7 Participants
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · Confident
|
6 Participants
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · Very confident
|
13 Participants
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · Extremely confident
|
3 Participants
|
|
Utility of Intervention - Confidence
Confidence in ability to find resources to help with pain · N/A
|
0 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · Not at all confident
|
5 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · Somewhat confident
|
9 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · Confident
|
5 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · Very confident
|
13 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · Extremely confident
|
3 Participants
|
|
Utility of Intervention - Confidence
Confidence in managing pain better in the future · N/A
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 60 daysPopulation: 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.
Assessed by study-specific questionnaire. Questions were answered on an Adjectival Ordinal 5-point scale where 1 = very difficult and 5 = extremely easy.
Outcome measures
| Measure |
Group I (Pain Management)
n=35 Participants
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
|
|---|---|
|
Utility of Intervention - Ease
Ease of understanding materials sent to the patient portal · Very difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding materials sent to the patient portal · Somewhat difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding materials sent to the patient portal · Neither easy nor difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding materials sent to the patient portal · Somewhat easy
|
2 Participants
|
|
Utility of Intervention - Ease
Ease of understanding materials sent to the patient portal · Very easy
|
15 Participants
|
|
Utility of Intervention - Ease
Ease of understanding mailed materials that discussed pain management techniques · Very difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding mailed materials that discussed pain management techniques · Somewhat difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding mailed materials that discussed pain management techniques · Neither easy nor difficult
|
1 Participants
|
|
Utility of Intervention - Ease
Ease of understanding mailed materials that discussed pain management techniques · Somewhat easy
|
2 Participants
|
|
Utility of Intervention - Ease
Ease of understanding mailed materials that discussed pain management techniques · Very easy
|
8 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the ASCENT website · Very difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the ASCENT website · Somewhat difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the ASCENT website · Neither easy nor difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the ASCENT website · Somewhat easy
|
2 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the ASCENT website · Very easy
|
3 Participants
|
|
Utility of Intervention - Ease
Ease of understanding follow-up phone calls with a member of the ASCENT team · Very difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding follow-up phone calls with a member of the ASCENT team · Somewhat difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding follow-up phone calls with a member of the ASCENT team · Neither easy nor difficult
|
2 Participants
|
|
Utility of Intervention - Ease
Ease of understanding follow-up phone calls with a member of the ASCENT team · Somewhat easy
|
1 Participants
|
|
Utility of Intervention - Ease
Ease of understanding follow-up phone calls with a member of the ASCENT team · Very easy
|
24 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the Action Plan · Very difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the Action Plan · Somewhat difficult
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the Action Plan · Neither easy nor difficult
|
1 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the Action Plan · Somewhat easy
|
0 Participants
|
|
Utility of Intervention - Ease
Ease of understanding the Action Plan · Very easy
|
15 Participants
|
Adverse Events
Group I (Pain Management)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II (Intervention Providers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group III (Medical Oncology Providers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place